Berghella2013 Vincenzo Berghella

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org

OBSTETRICS acesso em: 19/10/2022

Transvaginal cervical cerclage: evidence


for perioperative management strategies
Vincenzo Berghella, MD; Jack Ludmir, MD; Giuliana Simonazzi, MD; John Owen, MD

C ervical cerclage is the placement of


a stitch within and around the pe-
rimeter of the cervix, with the aim to re-
The objective was to review the evidence supporting various perioperative technical and
management strategies for transvaginal cervical cerclage. We performed MEDLINE,
inforce its integrity and keep it closed, to PubMed, EMBASE, and COCHRANE searches with the terms, cerclage, cervical cerclage,
prevent or treat cervical insufficiency cervical insufficiency, and randomized trials, plus each technical aspect (eg, suture, am-
and consequent spontaneous preterm niocentesis, etc) considered. The search spanned 1966 through September 2012 and was
birth (PTB). Transvaginal cerclage in not restricted by language. Each retrieved manuscript was carefully evaluated, and any
pregnancy was first reported in 1955; the pertinent references from the reports were also obtained and reviewed. All randomized
case was performed by Dr V. Shirodkar, trials covering surgical and selected perioperative, nonsurgical aspects of cerclage were
an Indian obstetrician, in 1951.1 Many included in the review. The evidence was assessed separately for history-, ultrasound-,
investigators have reported variations on and physical examination-indicated cerclage. Evidence levels according to the new
the surgical technique of transvaginal method outlined by the US Preventive Services Task Force were assigned based on the
cerclage, and the most common of these evidence. There are no grade A high-certainty recommendations regarding technical
is the McDonald procedure.2,3 A variety aspects of transvaginal cervical cerclage. Grade B moderate-certainty recommendations
of technical aspects of cervical cerclage include performing a fetal ultrasound before cerclage to ensure fetal viability, confirm
have been investigated for their efficacy gestational age, and assess fetal anatomy to rule out clinically significant structural ab-
in prolonging gestation. normalities; administering spinal, and not general, anesthesia; performing a McDonald
Safety and effectiveness of technical cerclage, with 1 stitch, placed as high as possible; and outpatient setting. Unfortunately,
aspects of cerclage may vary by the indi- no other recommendations can be made regarding the other technical aspects of cerclage.
cations for this procedure. When first de- Key words: cervical cerclage, stitch, technique
scribed, cerclage was used for 2 indications:
initially for prior second-trimester loss
with painless cervical dilation in the cur- Contemporary indications and no- pects of old preconception techniques
rent pregnancy (ie, physical examination menclature are listed in Table 1.4-9 In such as Lash or Mann is not planned be-
indicated) and soon after for recurrent sec- women with prior spontaneous preterm cause these techniques are used rarely, if
ond-trimester loss, not attributable to birth, singleton gestation, and transvag- at all. Additionally, a review of the tech-
other causes (ie, history indicated).1,2 inal ultrasound (TVU) cervical length of nical aspects of transabdominal or lapa-
less than 25 mm before 24 weeks, a meta- roscopic cerclage is not planned because
analysis of randomized trials has shown these are in many ways technically quite
From the Division of Maternal-Fetal Medicine, that ultrasound-indicated cerclage is as- different from transvaginal cerclage.
Department of Obstetrics and Gynecology, sociated with a significant 30% decrease in Our objective was to review the evi-
Thomas Jefferson University, Philadelphia, PA preterm birth less than 35 weeks and a sig- dence for efficacy of various periopera-
(Dr Berghella); Division of Maternal-Fetal
Medicine, Department of Obstetrics and
nificant 36% decrease in perinatal morbid- tive technical and management strate-
Gynecology, Pennsylvania Hospital, University ity and mortality.10 Current guideline gies associated with transvaginal cerclage
of Pennsylvania Perelman School of Medicine, statements now support cerclage place- placement, as analyzed by the different in-
Philadelphia, PA (Dr Ludmir); Department of ment for this indication.11,12 dications (Table 1) for this surgical proce-
Obstetrics and Gynecology, University of These recent efficacy data make a re- dure. Each strategy will be reviewed sepa-
Bologna, Bologna, Italy (Dr Simonazzi); and
Division of Maternal-Fetal Medicine,
view of the technical aspects of cerclage rately. Clinical assessment of the published
Department of Obstetrics and Gynecology, and their effect on pregnancy outcome data will follow evidence-based criteria,
University of Alabama at Birmingham, timely. An evaluation of the indications, emphasizing level I evidence (based on
Birmingham, AL (Dr Owen). gestational age of placement, contraindi- randomized clinical trials [RCT] or meta-
Received Dec. 19, 2012; revised Feb. 4, 2013; cations, and complications of cerclage is analyses) when available.
accepted Feb. 10, 2013. beyond the scope of this report.13 Be-
The authors report no conflict of interest. cause cerclage placement has not been Sources
Reprints not available from the authors. shown to be beneficial in multiple gesta- MEDLINE, PubMed, EMBASE, and
0002-9378/$36.00 tions,14,15 the assumption in this review COCHRANE searches were performed
© 2013 Mosby, Inc. All rights reserved.
http://dx.doi.org/10.1016/j.ajog.2013.02.020
is that cerclage is placed in a woman car- with the terms, cerclage, cervical cer-
rying a singleton. Review of technical as- clage, cervical insufficiency, and ran-

SEPTEMBER 2013 American Journal of Obstetrics & Gynecology 181


Expert Reviews Obstetrics www.AJOG.org

We could identify no published report


TABLE 1 investigating the prevalence of subclini-
Nomenclature, indication, and usual gestational cal IAI in women undergoing history-
age of placement for cervical cerclage4 indicated cerclage, but it is probably
Usual GA of present in less than 1% of these women
placement, because their cervix is typically closed
Name Indication wks and long. Therefore, amniocentesis is
History indicated Prior multiple (eg, ⱖ3) second-trimester 12-146 not indicated before history-indicated
losses and/or PTBs5
.............................................................................................................................................................................................................................................. cerclage.
Ultrasound indicated Short CL (eg, ⬍25 mm) by TVU 7
16-23 7
Subclinical IAI complicates about
..............................................................................................................................................................................................................................................
Physical examination indicated Dilated cervix on manual or speculum 16-23 8,9
1-2% of pregnancies in women undergo-
examination8,9 ing ultrasound-indicated cerclage.19 The
..............................................................................................................................................................................................................................................
CL, cervical length; GA, gestational age; PTB, preterm birth; TVU, transvaginal ultrasound. prevalence can be as high as 4-9% if the
Berghella. Technique of cervical cerclage. Am J Obstet Gynecol 2013. fluid is also cultured for Ureaplasma and
Mycoplasma species20,21; however, the
clinical significance of colonization with
domized trials, plus each technical aspect After each strategy was reviewed, evi- these microbes is unclear. In general,
(eg, suture, amniocentesis, etc) consid- dence levels were assigned based on the shorter cervical length (CL) is associated
ered. The search spanned 1966 through evidence according to the new method with higher rates of IAI.21 In approxi-
September 2012 and was not restricted outlined by the US Preventive Services mately 75% of cases, women screened
by language. Task Force (Table 2).16 with TVU and found to have a short CL
will have a closed and long cervix when
Study selection
Results examined by speculum and/or manual
Each retrieved manuscript was carefully
Preoperative considerations examination,22 and their rate of IAI is ex-
evaluated, and any pertinent references
Fetal ultrasound. There are no specific tremely low. The presence of sludge as
from the reports were also obtained and
randomized trials assessing the effective- detected by ultrasound has been associ-
reviewed. All randomized trials covering
ness of performing an ultrasound before ated with IAI in asymptomatic patients
surgical and selected perioperative, non-
a cerclage (Table 3). Based on indirect with a short cervix.23 Nonetheless, we
surgical aspects of cerclage were in-
evidence and clinical common sense, an could find no report that suggests im-
cluded in the review. In the absence of
ultrasound should be performed before proved pregnancy outcomes result from
randomized trials adequately covering
every cerclage placement to ensure fetal using amniocentesis, and thus, it is not
the intervention or related strategy, ana-
lytical data were reviewed. In the absence viability, confirm gestational age, and as- recommended.
of experimental or analytical data, obser- sess fetal anatomy to rule out clinically Subclinical IAI is discovered in ap-
vational data were evaluated. significant structural abnormalities.13 At proximately 13-28% of women with
Exclusion criteria included cerclage in least a crown-rump length and some acute cervical insufficiency (mostly asy-
multiple gestations, Lash or Mann pro- method of aneuploidy screening or test- mptomatic cervical dilatation on digital
cedures, cervical occlusion, and open or ing should be offered when cerclage is examination) in the second trimester
laparoscopic transabdominal cerclage. performed before 18 weeks (eg, history and who may be considered candidates
Each aspect of the cerclage technique indicated), and an anatomic survey per- for physical examination-indicated cer-
was reviewed separately. These included formed when cerclage is planned later clage.18,24 Amniotic fluid harvested from
preoperative, intraoperative, and post- (eg, ultrasound or physical exam indi- women with cervical dilatation of 2 cm
operative strategies. Preoperative con- cated) (recommendation B; level: low; or more, and cultured for Ureoplasma
siderations were fetal ultrasound; am- Table 3). and Mycoplasma, reveals an approxi-
niocentesis; screening for infection; and mately 50% incidence of IAI.17
the use of prophylactic antibiotics, tocolyt- Amniocentesis. We could identify no We could find no RCT evaluating the
ics, and progesterone. Intraoperative con- RCT assessing the effectiveness of per- safety and efficacy of amniocentesis
siderations included anesthesia method, forming a precerclage amniocentesis. for women with cervical changes prior to
cervicovaginal preparations, cerclage type Placing a cerclage in a woman with overt, physical examination-indicated cer-
(Shirodkar, McDonald), choice of suture, clinical intraamniotic infection (IAI) clage, but an ongoing RCT may help ad-
needle and number of stitches, cerclage places both fetus and mother at great dress this important clinical issue.25 Am-
height, and techniques for reducing pro- morbidity and even mortality risks and is niocentesis to rule out infection in
lapsed membranes. Postoperative consid- considered an absolute contraindica- women with second-trimester cervical
erations included outpatient vs inpatient tion.17,18 The prevalence of subclinical dilatation up to 4 cm has not been asso-
cerclage, activity restriction, and use of re- IAI depends on the clinical circumstance ciated with higher PTB or preterm pre-
inforcing cerclage. and cerclage indication. mature rupture of membranes rates.24

182 American Journal of Obstetrics & Gynecology SEPTEMBER 2013


www.AJOG.org Obstetrics Expert Reviews

TABLE 2
USPSTF ratings16: what the grades mean and suggestions for practice
Grade Definition Suggestions for practice
A The USPSTF recommends the service. There is high certainty that Offer/provide this service
the net benefit is substantial.
................................................................................................................................................................................................................................................................................................................................................................................
B The USPSTF recommends the service. There is high certainty that Offer/provide this service
the net benefit is moderate, or there is moderate certainty that the
net benefit is moderate to substantial.
................................................................................................................................................................................................................................................................................................................................................................................
C The USPSTF recommends against routinely providing the service. Offer/provide this service only if other considerations
There may be considerations that support providing the service in support the offering or providing the service in an
an individual patient. There is at least moderate certainty that the individual patient
net benefit is small.
................................................................................................................................................................................................................................................................................................................................................................................
D The USPSTF recommends against the service. There is moderate Discourage the use of this service
or high certainty that the service has no net benefit or that the
harms outweigh the benefits.
................................................................................................................................................................................................................................................................................................................................................................................
I Statement The USPSTF concludes that the current evidence is insufficient to Read the clinical considerations section of USPSTF
assess the balance of benefits and harms of the service. Evidence recommendation statement. If the service is offered,
is lacking or is of poor quality or conflicting, and the balance of patients should understand the uncertainty about the
benefits and harms cannot be determined. balance of benefits and harms.
Levels of certainty regarding net benefit
Level of certaintya Description
High The available evidence usually includes consistent results from well-designed, well-conducted studies in representative
primary care populations. These studies assess the effects of the preventive service on health outcomes. This
conclusion is therefore unlikely to be strongly affected by the results of future studies.
................................................................................................................................................................................................................................................................................................................................................................................
Moderate The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but
confidence in the estimate is constrained by such factors as:
● The number, size, or quality of individual studies.
● Inconsistency of findings across individual studies.
● Limited generalizability of findings to routine primary care practice.
● Lack of coherence in the chain of evidence.
As more information becomes available, the magnitude or direction of the observed effect could change, and this
change may be large enough to alter the conclusion.
................................................................................................................................................................................................................................................................................................................................................................................
Low The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of the
following:
● The limited number or size of studies.
● Important flaws in study design or methods.
● Inconsistency of findings across individual studies.
● Gaps in the chain of evidence.
● Findings not generalizable to routine primary care practice.
● Lack of information on important health outcomes.
More information may allow the estimation of effects on health outcomes.
................................................................................................................................................................................................................................................................................................................................................................................
USPSTF, US Preventive Services Task Force.
a
The USPSTF defines certainty as a “likelihood that the USPSTF assessment of the net benefit of a preventive service is correct.” The net benefit is defined as a benefit minus the harm of the preventive
service as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the nature of the overall evidence available to assess the net benefit of a preventive service.
Berghella. Technique of cervical cerclage. Am J Obstet Gynecol 2013.

Amniocentesis might help select pa- clined to have the amniocentesis in growth, but results from other meth-
tients who will benefit most from phys- these reports.18,21,24-26 For example, in ods for detecting subclinical IAI such
ical examination-indicated cerclage one study, women without IAI as con- as amniotic fluid Gram stain and glu-
and eliminate from consideration firmed by amniocentesis were com- cose can be obtained rapidly.
those who will likely not benefit. Al- pared with and had better pregnancy In summary, amniocentesis is un-
though the use of precerclage amnio- outcomes than women who had either necessary for women before history-
centesis has been associated with better positive cultures or who declined am- indicated cerclage (recommendation
outcomes compared with management niocentesis (some of whom likely had D; level: low; Table 3). There is insuf-
without amniocentesis, women man- positive cultures).26 If amniotic fluid is ficient evidence to recommend an am-
aged with amniocentesis were not sent for culture, it may take several niocentesis for women with cervical
compared with the women who de- days for the laboratory to confirm no shortening before ultrasound-indi-

SEPTEMBER 2013 American Journal of Obstetrics & Gynecology 183


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TABLE 3
Effectiveness for technical aspects of cerclage (USPFTF grade and level of certainty provided in parentheses)
Evidence Historic comparison

Physical examination Shirodkar, McDonald,


Variable History indicated Ultrasound indicated indicated 19551a 19572a
Preoperative
.......................................................................................................................................................................................................................................................................................................................................................................
Fetal ultrasound Yes (B; low) 13b Yes (B; low)13 Yes (B; low)13 N/A N/A
.......................................................................................................................................................................................................................................................................................................................................................................
Amniocentesis No (D; low) No (C; low)19,22c Consider (C; N/A N/A
moderate)18,21,24-26
.......................................................................................................................................................................................................................................................................................................................................................................
Perioperative antibiotics No (D; low)28 No (D; low)7,19,30-32 No (D; low)33 No No
.......................................................................................................................................................................................................................................................................................................................................................................
Perioperative tocolytics No (D; low) Consider (C; low)30,41 Consider (C; low)42 No No
.......................................................................................................................................................................................................................................................................................................................................................................
45
Perioperative progesterone No (D; low) No (D; low) No (D; low) No No
................................................................................................................................................................................................................................................................................................................................................................................
Intraoperative
.......................................................................................................................................................................................................................................................................................................................................................................
Anesthesia Spinal (B; low)46,47,49 Spinal (B; low)46,47,49 Spinal (B; low)46,47,49 ND ND
.......................................................................................................................................................................................................................................................................................................................................................................
McDonald vs Shirodkar McDonald (B; moderate)53,54,56-61 McDonald (B; moderate)62,63 McDonald (B; Shirodkar McDonald
moderate)53,56-61,64
.......................................................................................................................................................................................................................................................................................................................................................................
Suture Operator’s preference Operator’s preference Operator’s preference Human fascia lata Silk (but “not ideal”),
(I; moderate)5,69 (I; moderate)10 (I; moderate)67,69 (later changed to later #4 Mersilene
Mersilene thread) suture
.......................................................................................................................................................................................................................................................................................................................................................................
Needle Operator’s preference (I; low) Operator’s preference Operator’s preference Aneurism needle Mayo needle
(I; low) (I; low)
.......................................................................................................................................................................................................................................................................................................................................................................
Cerclage height Place stitch as high as possible Place stitch as high as Place stitch as high as Place stitch as high as Place stitch as high as
(B; moderate)52,72,73 possible (B; possible (B; possible possible
moderate)70,74,75 moderate)76
.......................................................................................................................................................................................................................................................................................................................................................................
Number of stitches 1 (B; moderate)78-81 1 (B; moderate)79,80,81 1 (B; moderate)80 1 1
.......................................................................................................................................................................................................................................................................................................................................................................
Membrane prolapse Operator’s preference (I; low) Operator’s preference Operator’s preference ND ND
management (I; low) (I; low)80
................................................................................................................................................................................................................................................................................................................................................................................
Postoperative
.......................................................................................................................................................................................................................................................................................................................................................................
Outpatient Yes (B; moderate)90,91 Yes (B; moderate)91 Yes (B; moderate)91,92 ND ND
.......................................................................................................................................................................................................................................................................................................................................................................
Activity restriction No (I; low) Individualize (I; low) Individualize (I; low) Bed rest for 15 days Bed rest for 3-7 days
.......................................................................................................................................................................................................................................................................................................................................................................
Repeat cerclage later if No (D; low)95d No (D; low)d No (D; low)d No Yes (but poor
necessary outcome)
................................................................................................................................................................................................................................................................................................................................................................................
N/A, not available or not applicable; ND, not discussed; USPSTF, US Preventive Services Task Force.
a
All physical examination–indicated cerclages; b USPFTF grade and level of certainty provided in parentheses (see details of scoring in Table 2); c Consider offering amniocentesis only if external cervical
os is dilated; d Consider only if cerclage slips off cervix because of poor technique.
Berghella. Technique of cervical cerclage. Am J Obstet Gynecol 2013.

cated cerclage or with the presence of Perioperative assessment for genital tract this strategy has not been found to be
intraamniotic sludge as detected by ul- infection and empiric antibiotic treatment. beneficial.28
trasound (recommendation C; level: We could identify no specific random- In candidates for ultrasound- or phys-
low; Table 3). There is also insufficient ized trial assessing the effectiveness ical examination–indicated cerclage be-
evidence to recommend an amniocen- of assessing for genital tract infection cause of cervical changes, the association
tesis for women with acute cervical in- and empiric antibiotic treatment be- with IAI and inflammation is directly
sufficiency (ie, cervical dilatation by fore cerclage. There is insufficient evi- proportional to the severity of cervical
digital examination) in the second tri- dence to evaluate whether the common changes (the more the cervix is dilated or
mester prior to a physical examina- practice of preoperative screening for short, the higher the incidence of IAI)
tion-indicated cerclage. Alternatively, and treating gonorrhea, chlamydia, or and indirectly related to the gestational
amniocentesis can be discussed and of- other sexually transmitted infections age at which these changes are detected
fered if utilized to select women for (STIs) is beneficial. STI screening (the earlier in pregnancy the cervix di-
cerclage and exclude those with sub- should probably be done based on risk lates and/or shortens, the higher the in-
clinical IAI, given the high rate (13- factors.27 cidence of IAI).21,29 Ureaplasma urealiti-
28%) of colonization. Subclinical IAI In women undergoing a history-indi- cum, if cultured for, is the most common
should be considered a contraindica- cated cerclage, whose cervix is not short organism isolated.17,29
tion to cerclage18 (recommendation C; or dilated, the empiric use of prophylac- Four of the RCTs that evaluated the
level: moderate; Table 3). tic antibiotics is not indicated because efficacy of ultrasound-indicated cerclage

184 American Journal of Obstetrics & Gynecology SEPTEMBER 2013


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used antibiotics at the time of cer- with higher rates of PTB, as compared with effect with ultrasound-indicated cer-
clage.7,19,30,31 Unfortunately, no separate no cerclage.38 clage placed for short CL.45
analysis was performed regarding their Prostaglandin metabolite levels are In summary, the evidence is insufficient
effect, except for an abstract, which re- high both before and after cerclage in to assess the risks and benefits of progester-
ported no benefit from the use of antibi- women with second-trimester cervical one use at the time of cerclage. We do not
otics and tocolytics compared with the dilatation.39 These associations raise the suggest its routine use perioperatively (rec-
use of neither.32 In at least 2 RCTs,19,30 question of the utility of tocolytics (in- ommendation D; level: low; Table 3).
the control group received the same an- cluding antiinflammatory agents) with Women already on 17P because of a prior
tibiotics as the cerclage group. (or without) cerclage for asymptomatic PTB, who also have indication(s) for cer-
Although some small retrospective women with a short CL. In an RCT, clage, should continue the 17P.
and poorly controlled studies have sug- women at high risk for PTB because of
Intraoperative strategies
gested benefit to antibiotics (and toco- both a prior poor obstetric history and a
Anesthesia
lytics) for physical-indicated cerclage,33 short TVU CL received either indometh-
We could find no randomized trial com-
the evidence is insufficient to recom- acin and an ultrasound-indicated cer-
paring general with regional anesthesia
mend their use. clage or bed rest alone.30 The combina-
for cerclage. General anesthesia was orig-
In summary, we recommend caution tion of indomethacin and cerclage was
inally suggested for the cerclage opera-
for use of antibiotics at the time (periop- associated with a significantly decreased
tion (nitrous oxide in McDonald’s re-
erative) of either ultrasound- or physical incidence of PTB compared with those
port).2 A small RCT comparing spinal
examination–indicated cerclage. Antibi- who did not receive either. Thus, the at-
with general anesthesia for women un-
otics for the prevention of PTB have tributable effect of indomethacin could
dergoing mostly history-indicated cer-
been associated with harm in other pop- not be formally assessed.30 This is the
clage showed similar rates of PTB as well
ulations at infectious risk for PTB34,35 RCT,30 albeit small, in which cerclage
as oxytocin concentrations and postop-
seemed to be most effective compared
(recommendation D; level: moderate; erative uterine activity.46 A retrospective
with other similar RCTs.7,19,31,40 In
Table 3). review also did not show differences in
women who received ultrasound-indi-
outcome between regional vs general an-
Tocolytic agents. We could find no ran- cated cerclage, perioperative indometh-
esthesia for cerclage placement.47 Re-
domized trial specifically assessing the acin for short TVU CL less than 25 mm at
gional anesthesia is now preferred for its
effectiveness of prophylactic tocolytics 14-23 weeks did not prevent PTB less
general safety compared with general an-
before a cerclage. than 35 weeks.41
esthesia for cerclage placement, based
Asymptomatic women receiving a his- In women undergoing physical exami-
mostly on noncerclage and anesthesia
tory-indicated cerclage, usually performed nation–indicated cerclage, indometha-
literature.48
at 12-14 weeks, are not experiencing con- cin has been associated with nonsignifi-
Spinal anesthesia is usually the pre-
tractions and therefore would not be ex- cant trends for preventing PTB as
ferred regional technique because the
pected to have any benefit from tocolysis. compared with no indomethacin.42 surgery rarely lasts longer than 30 min-
Painful uterine contractions with cer- In summary, there is insufficient evi- utes. A small RCT compared small-dose
vical change (ie, clinical preterm labor) dence to routinely recommend tocolyt- bupivacaine plus fentanyl vs lidocaine
in symptomatic patients is an absolute ics at the time of cerclage (recommenda- for spinal anesthesia and found them to
contraindication to cerclage placement.2 tion D; level: low for history-indicated have similar efficacy.48
Regarding ultrasound-indicated cer- cerclage; recommendation C; level: low Pudendal anesthesia has been shown
clage, most asymptomatic women with a for ultrasound- and physical examina- to be as effective as regional in a small
short CL at less than 24 weeks have evi- tion–indicated cerclage; Table 3). prospective, nonrandomized study.49
dence of some contractions when they are Progestogens. There are no specific ran- In summary, spinal anesthesia seems
placed on external monitoring.36 Usually domized trials assessing specifically the to be the preferred anesthesia for cer-
these are irregular and not felt by the pa- effectiveness of giving progestogens be- clage (recommendation B; level: low;
tient who has been screened with a sched- fore a cerclage. 17-alpha hydroxyproges- Table 3).
uled TVU CL. Cervical mucus inflamma- terone (17P) has been shown to be effec-
tory markers, such as interleukin (IL)-8, tive in preventing recurrent PTB in Intraoperative precerclage
fetal fibronectin, and others, have been re- women with prior spontaneous PTB.43,44 cervicovaginal preparations
ported as being helpful in predicting who Women already on 17P because of a prior There are several precerclage prepara-
might benefit from cerclage,37 but at this PTB, who also have indication(s) for cer- tions that are performed in the operating
time their use is investigational. In a cohort clage, should continue 17P. room prior to suture placement. None of
of women with short CL less than 25 mm, Although there were no significant these have been assessed by an RCT or
those with normal cervicovaginal IL-8 had statistical differences, the use of 17P in any controlled study. After the patient is
less PTB with cerclage, whereas in those women with prior PTB was associated placed in the dorsal lithotomy position
with elevated IL-8, cerclage was associated with trends for a cumulative beneficial and the bladder is emptied to reduce the

SEPTEMBER 2013 American Journal of Obstetrics & Gynecology 185


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these precerclage intraoperative steps


FIGURE 1 FIGURE 2
(recommendation I; level: low).
McDonald cerclage McDonald cerclage
Cerclage type: Shirodkar coronal section
vs McDonald
Transvaginal cerclage is usually per-
formed using either the McDonald or
Shirodkar approach with or without mod-
ifications, which have been reported.1,2 Al-
though proponents for each surgical
method exist, we could locate no RCT
comparing these 2 surgical methods.
In the McDonald technique, a purse-
string suture is placed in 4-6 bites cir-
cumferentially around the cervix, just
distal to the vesicocervical reflection (at
the junction of the ectocervix and the an-
terior ruggated vagina) and posteriorly, Each pass should be deep enough to contain
just distal to the vaginal-rectal reflection2 sufficient cervical stroma to avoid pulling through
(Figure 1).50 About 1 cm of spacing can but not too deep as to enter the endocervical
In a McDonald cerclage, a purse-string suture is be left between the exit of the last bite canal. The uterine vessels should be avoided lat-
placed in 4-6 passes circumferentially around and the entry of the new bite of suture erally. Particular attention should be given to the
the cervix. The suture should be placed as high into the cervix. It is unclear whether placement of the posterior bite because this is
as possible.50 placing the suture completely submuco- the most likely site of suture displacement.50
Reproduced, with permission, from Berghella et al.50 Reproduced, with permission, from Berghella et al.50
sally has any effects, as suggested by
Berghella. Technique of cervical cerclage. Am J Obstet
Berghella. Technique of cervical cerclage. Am J Obstet
Gynecol 2013.
some.51 Each pass should be deep Gynecol 2013.
enough to capture sufficient cervical
stroma to avoid pulling through and
later displacement but not so deep as to should be placed anteriorly or posteri-
chance of bladder injury, surgical prepa- enter the endocervical canal (and risk orly because RCTs have not addressed
ration of the perineum and vagina is rupture of the membranes, especially in this issue.
commonly performed, usually with Be- women with digital cervical changes The main difference between the
tadine. This step is done gently in the va- present). The uterine vessels should be McDonald and Shirodkar techniques is
gina if the membranes are protruding avoided laterally (Figure 2).50 The suture that the Shirodkar requires cephalad dis-
from the cervix. The cervix at this point should be placed as high as feasible, as section of the bladder and rectum off the
can be examined manually or with TVU. originally described,2 at least 2 cm or cervix to facilitate placement of the su-
Optimal exposure of the entire cervix more above the external os, as confirmed ture as close as safely possible to the in-
is crucial for optimal suture placement by recent data52 (see also Cerclage height ternal os (ie, as high as possible). Al-
and avoiding adjacent structures. Many section below). though surgical dissection with the
surgeons utilize a weighted speculum in In particular, the suture bite should be Shirodkar techniques theoretically al-
the posterior vagina, Breisky retractors placed securely on the posterior aspect of lows higher suture placement, this has
(Thomas Medical, Inc, Indianapolis, In- the cervix because this is the most likely not been conclusively demonstrated.
diana) for lateral vaginal wall retraction site of suture displacement2 (Figure 2).50 The McDonald technique also recom-
and Sims retractors (Thomas Medical, If the operator changes his/her position mended placing the suture as high as
Inc) for anterior retraction. The primary standing toward the side of the patient possible to approximate the level of the
surgeon performs the cerclage, and the and places the posterior bite in a forward internal os.2 With proper technique the
assistants help with retraction aimed at way, this may facilitate optimal suture McDonald suture can be placed close to
optimal visualization. We and others placement. The suture is tied after re- the internal os52 (Figure 3).50 The dissec-
utilize sponge ring forceps on the cervix moving any slack with gentle traction on tion and longer operating time for suture
to optimize visualization of the cervix the suture and countertraction on the placement (and later removal) of the
and provide the necessary countertrac- stroma; successive knots are tied, and the Shirodkar cerclage could theoretically
tion at the suture entry and exit sites. ends are left long enough (2-3 cm) to al- cause more complications than the
None of these intraoperative steps have low easy identification and removal (Fig- McDonald technique, but this again has
been evaluated in controlled trials. ure 3).50 Although we and others tie the not been evaluated in an RCT.
In summary, there is insufficient evi- suture anteriorly, no recommendations Considering only history-indicated
dence to assess the effectiveness of any of can be made regarding whether the knot cerclages, several series have shown sim-

186 American Journal of Obstetrics & Gynecology SEPTEMBER 2013


www.AJOG.org Obstetrics Expert Reviews

ultrasound- or physical examination– vdek, and metal wire as well as Mersilene


FIGURE 3
indicated cerclage, outcomes were simi- tape and others.1,2,5,7,19,30,65 Today the
McDonald cerclage
lar for the McDonald and Shirodkar most commonly used are Mersilene 5 mm
techniques.61 Given equivalent success tape (Thicon RS-21 or D-8113; Ethicon
rates and easier insertion and removal of Inc, Somerville, NJ)5,7,30,65 and large-cali-
the McDonald cerclage, many obstetri- ber nonabsorbable monofilament (eg,
cians have favored the McDonald Prolene, Ethicon, Inc).19
cerclage.53,56-60 In women undergoing history-indi-
In a patient-level metaanalysis of 4 cated cerclage, there are no specific data
RCTs analyzing only ultrasound-indi- to suggest the best suture. The largest
cated cerclage for short CL in singleton RCT ever reported, and which showed a
gestations, the rates of PTB were similar for benefit in women with 3 or more second-
McDonald vs Shirodkar techniques.62 It trimester losses or PTBs, used Mersilene
should be noted that the 3 randomized tri- tape.5
als that used the McDonald cerclage used a In women receiving ultrasound-indi-
short CL ⬍25 mm (mean, 17 mm) as in- cated McDonald cerclage, Mersilene
clusion criteria,19,30,40 whereas the one trial tape was associated with similar rates of
using Shirodkar used a short CL ⱕ15 mm PTB (24% vs 35%, respectively; P ⫽ .24)
(mean, 10 mm) as inclusion criteria.31 A compared with polyester-braided thread
regression analysis controlling for CL and (Mersilene or Ethibond) in a secondary
other baseline characteristics confirmed analysis of a RCT that included women
The suture is usually tied anteriorly, tight enough no differences in the incidences of PTB less
to admit a fingertip at the external os but closed with singleton gestations, prior PTB
than 35, less than 32, and less than 28 weeks 16-33 6/7weeks, and CL less than 25 mm
at the internal os. Successive knots are placed between the 2 techniques.62 A small retro-
(we usually place at least 5), and the ends are left between 16 and 22 6/7 weeks.10 Most pa-
spective review found a decreased inci- tients included in RCTs analyzed in
long enough (eg, 2 cm) to facilitate later re- dence of PTB less than 32 weeks (other
moval.50 metaanalyses that showed benefit from
rates of PTB were not reported) in their
Reproduced, with permission, from Berghella et al.50 cerclage in singleton gestations with
adjusted analysis with Shirodkar com-
Berghella. Technique of cervical cerclage. Am J Obstet prior PTB and short CL less than 25 mm
pared with the McDonald cerclage.63
Gynecol 2013. used Mersilene tape.14,66
Analyzing only physical examination–
Considering women with physical ex-
indicated cerclages done for manually
amination–indicated McDonald cer-
ilar efficacy of McDonald compared with detected cervical dilatation (usually of
clage, 1 retrospective study compared
Shirodkar cerclage.53,54 In women un- ⱖ1 cm), the rates of PTB were similar for
Mersilene tape, Tevdek, and Prolene.67
dergoing history-indicated cerclages, a McDonald vs Shirodkar techniques.53,64
The rates of PTB were similar in the 3
simpler Shirodkar technique, requiring Randomized trials5,7,14,30,65 and a
groups.67 Another small retrospective
only anterior fornix dissection, was asso- metaanalysis10 of selected trials that con-
ciated with similar incidence of PTB firmed ultrasound-indicated cerclage ef- study found braided suture to be associ-
compared with traditional Shirodkar in ficacy for the prevention of PTB reported ated with decreased rates of PTB less
a quasi-RCT.55 Given equivalent success data mostly on pregnancies in which the than 28 weeks and improved neonatal
rates and easier insertion and removal of McDonald cerclage was utilized. In the survival compared with Mersilene
the McDonald cerclage, investigators RCT in which the Shirodkar ultrasound- tape.68 In a small study that used mixed
have favored McDonald cerclage.53 indicated cerclage was used, cerclage was history- and physical examination–indi-
Several investigators have compared not found to be efficacious.31 cated McDonald cerclage, gestational
the efficacy of McDonald vs Shirodkar In summary, given these data, the age at delivery and latency were similar
cerclage in cohorts with different cer- McDonald technique is preferred over in women who received Mersilene tape
clage indications, limiting the interpre- Shirodkar because of its easier placement vs those who received Prolene.69
tation and external validity of the results. and removal, and its proven comparative Some surgeons lubricate the Mersilene
In women receiving either history- or effectiveness5,7,14,30,65,66 (recommenda- tape with either gel or Betadine for easier
physical examination–indicated cer- tion B; level: moderate; Table 3). threading through cervical tissue, but this
clage, several series have shown similar measure has not been evaluated in any study.
efficacy in preventing PTB of the Mc- Suture There are also no data to make a recommen-
Donald compared with the Shirodkar We could identify no randomized trials spe- dation regarding the numbers of knots or the
cerclage.53,56-60 Increased incidence of cifically comparing different types of cerclage placement of the knot anterior vs posterior.
cesarean section for cervical dystocia was suture. Several types of materials have been In summary, in the absence of data
noted with the Shirodkar technique in utilized, including human fascia lata,1 su- suggesting the superiority of one suture
one series.60 In women receiving either tures such as Mersilene,2 silk, Prolene, Te- type, the choice of suture should be in-

SEPTEMBER 2013 American Journal of Obstetrics & Gynecology 187


Expert Reviews Obstetrics www.AJOG.org

vestigated further and currently left to ble that cerclage increases cervical length second suture above the first, closer to
the operators’ preference (recommenda- in both the history-indicated72 and the the internal os if anatomically feasible.78
tion I; level: moderate; Table 3). ultrasound-indicated cerclage.74 In a re- One RCT79 and 3 retrospective stud-
cent study, the incidence of PTB less than ies78,80,81 evaluated the efficacy of cer-
35 weeks was 24% if the history-indi- clage with either placement of 2 or 1
Needle
cated cerclage height was less than 10 stitch. The randomized trial included
We could locate no specific randomized mm, 17% if 10-19 mm, and 10% if 20 only history-indicated cerclages. The in-
trial comparing different types of needles mm or greater.52 It is interesting to note cidence of PTB less than 34 weeks was
for cerclage. Shirodkar1 first described that a transabdominal cerclage, in which lower with 2 stitches (12%) compared
the use of an aneurism needle for cer- the stitch is placed at the anatomic inter- with the group with 1 stitch (41%), but
clage, to pass through the cervical stroma nal os, is associated with effective preg- this was not statistically significant.
at 3 and 9 o’clock inferior to the bladder nancy prolongation, even in women at
and rectal reflections dissected off the Moreover, the incidence of PTB was un-
the highest risk for PTB. usually high in the 1-stitch group, ac-
cervix. No controlled study has com- Most studies of ultrasound-indicated
pared this option with other types of nee- cording to the authors. Cervical length
cerclage suggest that placing the suture was significantly longer after 2 compared
dles, such as Mayo, etc. There is no study close to the internal os, or as high as pos-
comparing blunt vs sharp vs cutting with after 1 stitch. The 1-stitch technique
sible, is associated with a lower risk of did not recommend placing the suture as
needles. PTB compared with placement in the
In summary, there are insufficient high as possible but instead aimed to
middle or lower third of the cervix.70,74 A place it in the middle third of the cervix.
data to make any recommendation re- cerclage height of 18 mm or greater was
garding the safest and most effective nee- The 2-stitch technique included placing
associated with a lower incidence of PTB 1 suture in the lower and 1 in the upper
dle to use at the time of cerclage (recom- (4%) compared with placement less than
mendation I; level: low; Table 3). third of the cervix.79
18 mm (33%). The adjusted odds ratio In the first of 3 retrospective studies
was 0.10.70 Instead, in a study of 74
identified, patients with both history-
Cerclage height women who undertook ultrasound-in-
and ultrasound-indicated, and who un-
The distance from cerclage to external dicated cerclage, the cerclage height
derwent both McDonald and Shirodkar
os, as measured by TVU, is termed cer- demonstrated considerable variability
cerclages, were included and reported
clage height.52,70 We were unable to and minimal correlation with gestational
together, limiting the external validity in
identify a specific randomized trial com- age at delivery.75
any of these 4 groups. The type of suture
paring different cerclage heights for cer- In physical examination–indicated
used was also not reported. There was no
clage. Because one of the goals of cerclage cerclage, a cervical height of less than 10
statistically significant difference in PTB
is to reconstitute a closed endocervical mm was also associated with the highest
canal, both Shirodkar and McDonald rates of PTB, and the recommendation outcomes and complications in women
techniques described placing the suture was to place the stitch near the internal os who received 2 vs 1 stitch.78 In the sec-
as high as possible to approximate the to allow full restoration of the state of the ond retrospective study, women with
level of the internal os.1,2 Unless the sur- cervix.76 history-, ultrasound-, and physical ex-
geon takes special care at this step of the In summary, retrospective controlled amination–indicated cerclages were an-
procedure, most McDonald52,70 and data confirm the original recommenda- alyzed together. The incidence of PTB
even (importantly) most Shirodkar cer- tion of Shirodkar and McDonald: try to less than 35 weeks was similar in the 2-
clages71 are placed in the middle third of place the stitch as high as possible, close (48%) vs 1-stitch (41%) groups. Inter-
the endocervical canal. Although the to the internal os, hopefully attaining a estingly, cerclage height was also higher
Shirodkar technique might have a theo- cerclage height of more than 2 cm be- in the 2- vs 1-stich groups.80 In the third
retical advantage in creating a larger cer- cause this technical detail is associated and most recent retrospective study,
clage height, a retrospective study found with better prevention of PTB compared by far the largest (n ⫽ 444 cerclages),
no difference in cerclage height 2 weeks with placing the stitch lower along the history- and ultrasound-indicated cer-
after either the McDonald or Shirodkar cervical canal (recommendation B; level: clages were analyzed separately. PTB less
procedure.54 Patient selection may have moderate; Table 3). than 37 weeks was not significantly dif-
explained this lack of difference (ie, ferent between the 2- and 1-stitch groups
women with a shorter presurgery cervix Number of cerclage stitches for both the history-indicated group
may have been more likely to undergo Shi- As a modification of the McDonald (39% vs 35%, adjusted odds ratio [aOR],
rodkar). Thus, selection bias could explain method, some investigators have advo- 1.38; 95% confidence interval [CI],
the null finding. cated placing an additional stitch (total 0.64⫺3.01); and the ultrasound-indi-
Several retrospective studies of history- of 2). Originally a second stitch was cated group (44% vs 49%; aOR, 0.66;
indicated cerclage suggested that placing placed to support the first suture and 95% CI, 0.27⫺1.61), even after adjusting
the stitch close to the internal os would prevent its displacement.77 More re- for demographic differences and suture
result in better outcomes.72,73 It is nota- cently an additional goal is to place the type.81

188 American Journal of Obstetrics & Gynecology SEPTEMBER 2013


www.AJOG.org Obstetrics Expert Reviews

Placing a second stitch at the external low safe cerclage without rupture of Activity restriction
os, aiming to keep the mucus plug in membranes in cases of membrane pro- We could locate no controlled study of
place, has been termed cervical occlu- lapse, which is successfully retracted. postcerclage activity restriction. Both
sion. A recent RCT showed no additional Cerclage may be effective up to 4 cm of Drs Shirodkar (a “fortnight”) and Mc-
benefit from this second cervical occlu- cervical dilation,9 but efficacy appears to Donald (“3 to 7 days”) suggested bed rest
sion stitch compared to just one stitch.82 diminish if the cervix is more than 4 cm after their physical examination–indi-
In summary, placing one stitch, as dilated.89 cated cerclages.1,2 There is evidence that
originally described, appears sufficient, In summary, there are insufficient decreased activity such as bed rest, inpa-
especially if well placed (as high as possi- data to make any recommendation re- tient (as just described) or outpatient,
ble). It does not appear that placing a sec- garding technical aspects aimed at re- does not prevent PTB.93 There is level I
ond stitch is beneficial compared with ducing membrane prolapse and allow evidence that prophylactic bed rest in-
placing just 1 stitch for cerclage. We sug- placement of cerclage in these women creases PTB in twin gestations.94 Women
gest placing a second stitch at the time of placed on decreased activity should be ad-
(recommendation I; level: low; Table 3).
initial cerclage only if the initial stitch is vised there is no proven benefit associated
observed to be too low on the cervix, and with this intervention and there are potential
Postoperative care
gentle pulling on this first stitch may al- life-threatening risks such as thromboembo-
Outpatient vs inpatient cerclage
low placing a second stitch much closer lism. Although historically vaginal inter-
to the internal os, at least 2 cm above the The length of hospitalization for the course was restricted after cerclage place-
external os (recommendation B; level: placement of cerclage has been evaluated ment, there are no data to support this
moderate; Table 3). in a few studies, including an RCT. recommendation.
For history-indicated cerclages, there In summary, there is insufficient evi-
Management of membrane prolapse was no benefit from continued hospital- dence to recommend any type of activity
and/or advanced cervical dilatation ization for 48 hours as compared with restriction after cerclage placement (rec-
We could find no RCT to assess the com- same-day discharge 2-4 hours after the ommendation I; level: low; Table 3).
parative effectiveness of techniques procedure in a retrospective study.90
aimed at reducing membrane prolapse The only RCT identified comparing Reinforcing (repeat) cerclage
and allow placement of cerclage. Several outpatient (discharge after 3-5 hours) vs and cerclage revision
technical suggestions have been de- inpatient (for 3 days) cerclage included Reinforcing cerclage, defined as a cer-
scribed.83 Trendelenburg can be used to history-indicated, ultrasound-indicated, clage placed in a woman with a preexist-
harness the effect of gravity. Iatrogenic and physical examination–indicated ing cerclage, has not been evaluated by
bladder filling can also assist membrane procedures.91 Incidence of PTB and an RCT. TVU CL after cerclage predicts
replacement. For example, infusion of complications was similar, and the au- the incidence of PTB.74-76 However, no
500 mL of saline in the bladder helps thors concluded that outpatient cerclage intervention has been shown to prevent
retract the membranes but also elevates was preferable and associated with cost PTB if the CL shortens further after cer-
the cervix in the vaginal canal, which re- savings and less time away from home clage. In women with a history-indicated
quires significant deep exposure to accom- for patients.91 cerclage who develop a short TVU CL
plish cerclage. A moist sponge on ring for- For physical examination–indicated less than 25 mm at 14-23 6/7 weeks, rein-
ceps or a 16-French Foley balloon (with tip cerclages, McDonald had originally sug- forcing (second or repeat) cerclage is asso-
cut) have been used successfully to replace gested 5 days of hospitalization.2 Outpa- ciated with a higher incidence of PTB.95
membranes mechanically.83 There is insufficient (no) evidence to rec-
tient procedures, with discharge after 2-4
Amniocentesis can also be used to re- ommend the placement of a second cer-
hours and “advice to take it easy for 48
duce membrane prolapse and facilitate clage should the original one become dis-
hours,” was associated with similar out-
physical examination–indicated cer- placed (cerclage revision).
comes compared with inpatient stay in a
clage.84-87 The amount of fluid removed In summary, there is insufficient evi-
is usually about 150-250 mL.86,87 The retrospective study.92
In summary, given the lack of evidence dence to recommend the placement of a
only study with controls who did not re- reinforcing cerclage. Based on limited
ceive amniocentesis demonstrated a 90 for the benefit of hospitalization, it ap-
pears that cerclage can be safely per- data that show harm,95 we do not advo-
day longer interval to delivery in the am- cate reinforcing cerclage (recommenda-
niocentesis group.87 Stay suture around formed in the outpatient setting (ie, dis-
charge the same day of the procedure). tion D; level: low; Table 3).
the cervix with traction have also been
described,86 using stay silk sutures to pull In women with cervical changes at Conclusion
the cervix around the Foley to then be higher risk for infection and PTL, espe- More than 60 years after the first cerclage
able to place the suture. Others use ring cially if after 20 weeks, a brief 24 hour in pregnancy was performed,1,2 there
forceps for traction. postoperative stay might be considered still are not any grade A recommenda-
Ultrasound has been used to check the for observation (recommendation B; tions or any level of certainty high evi-
degree of membrane prolapse88 and al- level: moderate; Table 3). dence as to how the procedure should be

SEPTEMBER 2013 American Journal of Obstetrics & Gynecology 189


Expert Reviews Obstetrics www.AJOG.org

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