International Journal of Reproduction, Contraception, Obstetrics and Gynecology

Medda S et al. Int J Reprod Contracept Obstet Gynecol. 2018 Mar;7(3):996-1001

www.ijrcog.org pISSN 2320-1770 | eISSN 2320-1789

DOI: http://dx.doi.org/10.18203/2320-1770.ijrcog20180880
Original Research Article

A study of the outcome of pregnancy complicated by

obstetric cholestasis
Samik Medda*, Sibani Sengupta, Upasana Palo

Department of Obstetrics and Gynecology, Vivekananda Institute of Medical Sciences, Kolkata, West Bengal, India

Received: 28 December 2017

Revised: 21 January 2018
Accepted: 24 January 2018

*Correspondence:
Dr. Samik Medda,
E-mail: [email protected]

Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Background: Obstetric cholestasis is one of the most common causes of liver disease in pregnancy. Present study
was carried out to study the incidence of Obstetric Cholestasis and its feto-maternal outcome in a tertiary care
hospital.
Methods: It is a prospective epidemiologycal study during a period of one year (2014 to 2015) over 100 pregnant
ladies suffering from pruritus and detected as having Obstetric Cholestasis. They were followed up and maternal as
well as fetal-neonatal outcome recorded. Appropriate statistical analysis done as applicable.
Results: The incidence of Obstetric Cholestasis in our hospital was 9.9%. Majority of cases (43.0%) are diagnosed in
late gestational age, mostly during 28 to 32 weeks period of gestation. Maternal morbidities are due to sleep
disturbance (60/100), dyslipidemia, coagulation abnormality, PPH (10.0%) and increase chance of operative delivery
(66.0%). Neonatal morbidities are mainly due to fetal distress, prematurity (22.0%), low birth weight (32/100) and
meconium staining of amniotic fluid (42.0%). Maximum number of patients are delivered at 37 to 38 weeks, due to
active and early intervention.
Conclusions: Early diagnosis and active maternal and fetal surveillance is of utmost importance to avoid adverse
outcomes.

Keywords: Epidemiological study, Obstetric cholestasis, Outcome

INTRODUCTION in its incidence.1 The incidence of OC among Indian

women has been reported to be about 1%.3,4
Obstetric cholestasis is one of the most common causes
of liver disease in pregnancy. It is associated with Obstetric cholestasis classically manifests in second or
significantly high adverse maternal and fetal outcome.1 third trimester with pruritus and deranged liver function
Obstetric cholestasis (OC) or Intrahepatic cholestasis of test. The etiology of ICP is mostly unknown, but it is
pregnancy (ICP) is a cholestatic disorder characterized by believed to be multifactorial with genetic, environmental
unexplained pruritus during pregnancy with elevated or hormonal factors being involved.5-7 Impairment of the
serum bile acids (>10 μmol/L) and/or transaminases in function of major hepatocellular canalicular transporters
late second and third trimester of pregnancy, in absence lead to cholestasis.
of other liver disease, and spontaneous resolution of signs
and symptoms within two to three weeks after delivery.1,2 Obstetric cholestasis is associated with significant
maternal morbidities. The main maternal impact for
Obstetric cholestasis has been observed in almost all women with cholestasis is pruritus with no skin changes,
ethnic groups, but there is relevant geographical variation worse at night and most intense in the palms of the hands

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and soles.5-7 They have an increased risk for postpartum Maternal outcome was studied in reference to insomnia
hemorrhage, dyslipidemia, preterm labour and operative due to severe pruritus, associated dyslipidemia and
interference.7,8 deranged coagulation profile (increase PT), mode of
delivery, preterm labour, preterm pre-labour rupture of
Intrahepatic Cholestasis of pregnancy can have membrane, postpartum hemorrhage.
devastating consequences for the fetus with perinatal
mortality reaching up to 11% to 20% in untreated cases6. Fetal outcome was studied in reference to prematurity,
Adverse fetal outcomes associated with the conditions abnormal CTG, fetal distress or hypoxia, meconium
include preterm labour, preterm prelabour rupture of stained liquor, low birth weight (less than 2.5 kg) or Intra
membrane, fetal distress, abnormal CTG, meconium Uterine Growth Restriction, NICU admission rate and
staining, spontaneous intrauterine death.5,9-11 perinatal death (IUFD/Still born).

Ursodeoxycholic acid (UDCA) is considered to be a safe Statistical analysis

treatment option in the later part of pregnancy.12,13 The
condition typically resolves within 48 hours of women Statistical Analysis was performed with the help of Epi
giving birth, with biochemical markers predominantly Info (TM) 3.5.3 as per the recommendations of the
becoming normal within 2-4 weeks postnatally.5 Centers for Disease Control and Prevention (CDC). Test
of proportion (Z-test) and t-test were used to test the
Present study is aimed to detect the incidence of OC in significant difference. A p value ≤0.05 was considered
our hospital and follow up those pregnancies to evaluate statistically significant.
maternal and perinatal outcome.
RESULTS
METHODS
The total number of deliveries during the one year study
Our prospective epidemiological study was performed in period, were 3876 in this hospital, among them 384
Ramakrishna Mission Seva Prathishthan Hospital, patients had Obstetric Cholestasis. So, the incidence of
Kolkata over one year (May 2014 to April 2015). The OC was 9.9%. The incidence of ICP were 9.7% in
diagnosis of obstetric cholestasis was made by clinical primigravida (167 of 1719) and 10.0% in multigravida
symptom of pruritus without a skin rash affecting mainly (217 of 2157) accordingly showing no significant
extremities and worsening at night, associated with difference (Z=0.07; p=0.94) (Table 1).
biochemical evidence of cholestasis in form of elevated
serum transaminases (ALT and AST) with or without Table 1: Incidence of OC according to gravida.
elevated serum bilirubin, in the absence of other liver
disease. Postpartum resolution was studied in reference to Total Obstetric
Parity %
improvement of pruritus and abnormal Liver Function number cholestasis
Tests after 6 weeks of delivery. Primigravida 1719 167 9.7
Multigravida 2157 217 10.0
History taking, clinical examination and laboratory Total 3876 384 9.9
investigations were carried out to diagnose obstetric
cholestasis and calculate disease frequency. 64.7% of multigravida women (11 of 17 who had history
of previous viable pregnancy) had past history of OC
Among them, initial 100 cases were included in the study which was significantly higher (Z=4.15; p=0.0001)
as sample cases for monitoring clinical nature of the (Table 2).
disease, relevant biochemical alterations and outcome of
pregnancy. Other relevant investigations were done to Table 2: Distribution of past history of OC among
exclude other conditions of altered LFT like Hepatitis multipara patients.
serology, hepato-billiary ultrasonography, liver
autoimmune screen, etc. Past history Number %
Yes 11 64.7
LFT was repeated every 2-4 weeks interval as required. No 6 35.3
Fasting lipid profiles and coagulation profiles were also Total 17 100.0
detected. In present study serum levels that are more than
upper limit of pregnancy specific reference ranges are The mean age (mean±s.d.) of the patients was 27.53±4.49
considering as positive for OC. However, due some years with range 18-44 years and the median age was
limitation, measurement of serum bile acid could not be 28.0 years. Most of the patients (44.0%) were with age
done. All patients included in the study were given between 26-30 years (Z=2.51; p=0.0121). Only 3.0% of
ursodeoxycholic acid 300-1200 mg/day in divided doses the patients were >35 years of age and 6% were with age
for the rest of the antenatal period. ≤ 20 years (Figure 1).

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 Medda S et al. Int J Reprod Contracept Obstet Gynecol. 2018 Mar;7(3):996-1001

profile. Incidence of PPH and PROM were same, 10% in

45%
present study. Also 7% of patients had spontaneous onset
40% of labour pain before 37 weeks and delivered preterm
35% babies (Table 3).
30%
% of patients

25% Table 4: Gestational age at delivery (in weeks).

20%
Gestational age of delivery
15% Number %
(in weeks)
10%
<35 2 2.0
5%
35-36 22 22.0
0% 37-38 62 62.0
≤20 21-25 26-30 31-35 >35
Age (in years) 39-40 14 14.0
Total 100 100.0

Figure 1: Age distribution of OC in study population. The mean gestational age of delivery was 37.28±1.18
weeks with range 33 – 40 weeks and the median was 37.0
weeks. 62% of the patients delivered between 37-38
45% weeks which was significantly higher (p<0.01). Only
40% 2.0% patients delivered before 35 weeks of gestation and
35% none after 40 completed weeks (Table 4).
30%
% of patients

25% Table 5: Mode of delivery.

20%
Mode of Delivery Number %
15%
Elective CS 32 32.0
10%
Emergency CS 30 30.0
5%
Forceps 4 4.0
0%
<28 28-32 32.1-36 >36
Vaginal delivery 34 34.0
Gestational age at diagnosis (in weeks) Total 100 100.0

Number of the total cases of operative delivery (66%),

Figure 2: Gestational age at diagnosis (in weeks). which comprised of Elective CS (32%), Emergency CS
(30%) and Forceps delivery (4%), were significantly
The mean gestational age at diagnosis of the patients was higher than that of VD (34%) (p<0.01) (Table 5).
31.80±4.39 weeks with range 17-38 weeks and the
median was 32.0 weeks. Most of the patients (43.0%) Table 6: Distribution of fetal outcomes.
were diagnosed at gestational age of 28-32 weeks
followed by 32.1-36 weeks (36.0%) which was Fetal Outcome Number %
significantly higher than that of other gestational age Fetal distress 23 23.0
groups (p<0.01). 11% and 10% patients were diagnosed Abnormal CTG 17 17.0
at <28 weeks and >36 weeks of gestation respectively Meconium stained liquor 41 41.0
(Figure 2). LBW 32 32.0
IUFD or still born 2 2.0
Table 3: Distribution of maternal outcomes. NICU admission 27 27.0
Preterm birth 22 22.0
Maternal outcome Number %
Sleep disturbance 60 60.0
Among 100 cases included in present study, 23 patients
Dyslipidemia 30 30.0
had evidence of fetal distress (23.0%), 17 patients had
Deranged coagulation profile 19 19.0
abnormal CTG (17.0%), 41 patients had meconium
PPH 10 10.0 stained liquor (41.0%), 22 patients had preterm birth
PROM 10 10.0 (22.0%) excluding IUFD, 32 patients had delivered low
Operative delivery 66 66.0 birth weight babies (32.0%) among them majority had
Preterm labour spontaneous 7 7.0 IUGR and others being preterm, 27 neonates required
admission to NICU (27.0%). There were 2 intrauterine
Out of total cases of maternal outcomes operative fetal deaths (2.0%), both delivered preterm. No perinatal
delivery (66%) and sleep disturbance (60%) were death occurred among these cases while 39 patients had
significantly higher (p<0.01). It also shows, 30% patients no perinatal complications (39.0%). Out of total cases of
of OC had dyslipidemia, 19% had abnormal coagulation fetal outcome, meconium stained liquor (41%) and LBW

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 Medda S et al. Int J Reprod Contracept Obstet Gynecol. 2018 Mar;7(3):996-1001

(32%) were significantly higher (p<0.01) in present study et al (mean age 31±4 weeks) and Kenyon AP et al (33.7
(Table 6). weeks).3,24

Table 7: Post partum resolution after 6 weeks of This study shows 60% of the patients had sleep
delivery. disturbance, due to severe pruritus at night. Generalized
pruritus more affecting to palm and sole were the cardinal
Post partum resolution Number % features without skin rash and clinical jaundice. Total
Normal LFT 98 98.0 serum bilirubin rarely exceeds 4-5 mg/dl. Serum
Persisting Raised LFT 2 2.0 aminotransferases (ALT and AST) are also elevated 2-10
Total 100 100.0 fold above normal ranges in our patients but none exceed
1000 U/L.1,9 Serum levels of alkaline phosphatase may
In present study, in most of the cases normal LFT (98%) rise up to 7-10 times normal but are difficult to interpret
was found (p<0.01) after 6 weeks of delivery and due to elevation of the heat stable placental isoenzyme.
symptomatically pruritus relieved. So that disease Serum total bile acid levels usually exceed ≥10 μmol/L.
resolved within 6 weeks of delivery (Table 7).
In this study, we treated our patients with topical
DISCUSSION emollients like calamine lotion and oral Ursodeoxycholic
Acid (300-1200) in divided doses. We found complete
Obstetric Cholestasis is a relatively common cause of symptomatic improvement in 65% cases and partial
hepatic impairment in pregnancy. It has a complex response in 30%. Rest 5% of the patients did not get
etiology with genetic, endocrine and environmental relieved of pruritus. Biochemical improvement,
components. Intrahepatic cholestasis of pregnancy was evidenced by decreasing Transaminases levels, was
originally described by Ahlfeld as recurrent jaundice in observed in 85% cases (p<0.01). Deveer R et al found
pregnancy that resolved following delivery.14 serum transaminases to be decreased significantly in 60%
cases with UDCA treatment.25
The incidence of OC shows large variation between
different countries and populations.1 According to Abedin 30% of our patients had dyslipidemia. Dann AT et al also
et al, in the United Kingdom, OC affects only 0.6% of found in their study that total cholesterol levels raised
pregnancies in white Caucasians, but 1.4% of more in OC significantly.26 This table shows 19% of the
pregnancies of Indian and Pakistani origin.15 The highest patients had deranged coagulation profile with increased
incidence of OC (14%) has been reported from Chile PT or APTT level. Dang A et al (29.78%) and Ray A et al
(Reyes), but a much lower incidence (2-4%) was found in (25%) reported significant increased incidence of PPH, as
the latest report (Germain et al).16,17 In this study, we a result of malabsorption of vitamin K, due to
found the incidence of ICP was 9.9%, which is steatorrhoea of cholestasis, leading to coagulation
comparable to high incidence of 9.3% reported by Gupta problem.23,24 Kenyon AP et al found a high incidence of
A et al and 8.2% by Padmaja M et al.18,19 However it is PPH in OC patients who did not receive vitamin K
prudent to mention that, our hospital is a tertiary referral compared to those who did (45% vs 12%).3 Present study
center and the incidence of high risk pregnancy is higher. shows 10% incidence of PPH. Here, 19 patients had
Hence the incidence of OC is expected to be higher than deranged coagulation profile and received vitamin K,
in community. There was no significant difference in among them 4 (21.05%) patients had PPH. Other 6
incidence according to parity (primigravida 9.7% and (7.4%) patients who had PPH belongs to those 81 patients
multigravida 10.0%). having normal coagulation parameters, hence not
received vitamin K. PROM was found in 10% of cases in
Heinonen S et al reported that women of relatively present study and 7% of patients had spontaneous
advanced age (>35 years) were at increasing risk of preterm labour. Padmaja M et al reported a significant
developing OC, but in this study, mean age of the patients increase in incidence of PPROM (8.9%) and PTL (44%)
was 27.53±4.49 years (range 18-44 years) and most of the in OC group.19
patients (44.0%) were with age between 26-30 years.20
This is similar to the results shown by Rasheed S et al (28 This study shows incidence of operative delivery (66%),
years+ 5.19) and Sosa SY et al (29.2±6.8 yrs).21,22 which comprises of Elective CS (32%), Emergency CS
Recurrence of OC in subsequent pregnancies were upto (30%) and Forceps delivery (4%). It was significantly
60-70% (Ray A et al).23 We also found a significantly higher than that of VD (34%) (p<0.01). Kenyon AP et al
higher (64.7%) (Z=4.15; p=0.0001) recurrence rate in found caesarean section rate 36.0%. Rasheed S et al
multiparous women. reported spontaneous delivery rate of 80% with
emergency LSCS rate of 16.7% and elective LSCS rate of
The mean gestational age at diagnosis of ICP was 3.3%.3,21 It is often not clear whether this higher rate is as
31.80±4.39 weeks and the median were 32.0 weeks. Most a result of active management or because of
of the patients were diagnosed between 28-32 weeks complications as a result of the disease. Caesarean
(43.0%) and 32.1-36 weeks (36.0%) which was section rate (62%) was very high in present study, as like
corroborating to the findings of other authors like Dang A many UK hospitals, our tertiary private hospital also

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 Medda S et al. Int J Reprod Contracept Obstet Gynecol. 2018 Mar;7(3):996-1001

adopts a policy incorporating antenatal surveillance of mainly appears around 28-32 weeks gestation. There are
some form with elective delivery by 37-38 weeks. Hence, several maternal morbidities detected as sleep
most of the patients (62%) were with gestational age of disturbance, dyslipidemia, coagulation abnormality, PTL,
delivery between 37-38 weeks which was significantly PROM and PPH with increased rates of operative
higher (p<0.01) (mean 37.28±1.18 weeks). delivery. Maximum number of patients are delivered at
37 to 38 weeks, due to active maternal and fetal
Some studies, Roncaglia N et al and Fisk NM et al have surveillance and early intervention to prevent sudden
reported good outcomes with a policy of induction of fetal death at late gestation. Neonatal morbidities are
labour at 37 or 38 wk gestation.27,28 Many clinicians in mainly due to fetal distress, prematurity, low birth weight
the UK have adopted this practice as the IUDs appear to and meconium staining of amniotic fluid. Fetal outcomes
cluster at later gestations. However there have been very are improved with a variety of strategies of active
few reports of the gestational week at which the IUD management, although the most effective intervention has
occurs, nor have there been any large prospective studies not currently been established. Ursodeoxycholic acid
of whether drug treatment or early delivery prevents treatment is associated with marked improvement of
adverse fetal outcomes. symptoms and biochemical abnormalities. Almost all
patients have postnatal resolution within 6 weeks of
Fetal distress was found in 23% of the cases in present delivery.
study, as well as abnormal CTG in 17% of cases. 41
patients had meconium stained liquor during delivery However, Large therapeutic trials are required to
(41.0%) which was significantly higher (p<0.01). establish which specific drug treatments or management
Alsulyman OM et al also found that risk of meconium strategies are effective at reducing the rates of adverse
passage was higher in the cholestasis group (44.3% cases maternal and fetal outcomes. In this study the sample size
vs. 7.6%of control).29 It has been suggested that both fetal is small, and the time period is limited-it therefore may
distress and increased gut motility by bile acids is the not reflect the true magnitude of the problem; however,
cause of raised incidence of MSL. the ‘take home message’ is: early diagnosis and active
maternal and fetal surveillance is of utmost importance to
22% of the babies has been suffering from prematurity avoid adverse outcomes.
(7% preterm labour, 15% iatrogenetic due to fetal distress
or abnormal CTG). This study shows that, mean birth ACKNOWLEDGMENTS
weight of the babies were 2.80±0.36 kg (range 1.50-3.80
kg). LBW (birth weight <2.5 kg) was found in 32% of the Authors would like to thank Dr. Sukanta Misra Professor
cases. Most of these babies had IUGR, and others had and HOD Gynecology and Obstetrics Department for his
low birth weight due to preterm birth. Sosa S Y et al22 enumerable contribution, Dr. S. Mondal (statistician) for
(2010) reported that neonates of OC mothers had an helping in statistical analysis and patients who take
average weight of 2381±533 gm, while children of participation in this study.
mothers in the control cohort had an average weight of
3118±470 gm (p>0.001). Williamson C et al observed Funding: No funding sources
38% preterm delivery rate in cholestasis patients.30 IUFD Conflict of interest: None declared
or Still Born was found only in 2 (2.0%) cases in the Ethical approval: The study was approved by the
study, one at 33 weeks and another at 36 weeks. Institutional Ethics Committee
Alsulyman OM et al also found 2 of 79 patients having
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