1

FCPS Thesis Research Protocol

Protocol No
Date of submission of
1
protocol
Relevant faculty of
2 Obstetrics & Gynaecology
BCPS
D R . M S T . H A Z E R A K H A T U N
3 Name of the examinee

Dr. Mst. Hazera Khatun

Address of
FCPS (Obstetrics & Gynaecology) part-II student,
correspondence of the
4 Department of Obstetrics & Gynaecology,
examinee and contact
Institute of Child and Mother Health, Matuail, Dhaka.
phone number
Phone: 01724005495

Outcome of combined mifepristone and misoprostol versus

5 Title of the thesis
misoprostol alone in the management of first trimester abortion.

6 Summary Background:
First trimester abortion is one of the most common complication of
pregnancy occurring in 10-20% of clinically recognized
pregnancies. Abortion can cause physical harm, such as
excessive bleeding and infection, and substantial psychological
harm, including anxiety, depression and post-traumatic stress
disorder. In this study, mifepristone and misoprostol versus
misoprostol alone and the outcome of this combination in the
management of first trimester abortion will be determind.

Objective:
To determine the outcome of combined mifepristone and
misoprostol with misoprostol alone in the management of first
trimester abortion.
 2

Design: Randomised controlled trial (RCT)

Setting: Department of obstetrics and Gynaecology, Institute of

Child and Mother Health (ICMH), Matuail, Dhaka.

Patient (s):
For this purpose 88 women with first trimester abortion will be
selected on the basis of inclusion and exclusion criteria. Inclusion
criteria will be women with first trimester abortion with a period of
gestation up to 14 weeks (ultrasongraphic diagnosis), patient got
at least 1 week of expectant treatment, haemodynamically stable
women, axillary temperature of less than 98.60F. Exclusion criteria
will be patient age <16 years, hemodynamic instability, sign of
infection, contraindication for mifepristone or misoprostol, potential
interaction between study medication and other medication.
Inability to give informed consent, a known clotting disorder or use
of anticoagulants or known risk factors for or presence of a
cardiovascular disease.

Intervention (s):
Participants will be divided into two equal, Group A and Group B
each containing 44 patients. Each patient/guardian will be offered
two sealed envelope containing folded piece of paper bearing later
A or B and will be requested to peak up one of these. Those who
will pick A will be selected for Group A and those who' will pick B
will be selected for group B.

In Group A 200mg mifepristone will be given on empty stomach in

such a way that mifepristone will be placed orally for half an hour
than swallowed. After 24 to 48 hours two doses of misoprostol
400µg will be given orally 4 hours apart. In Group B only two
doses of 400µg misoprostol will be given orally, 4 hours apart. In
both groups, if no tissue is lost after 24 hours, two more doses of
oral misoprostol 400 µg (4 hour apart) will be given, approximately
 3

24 hours after the first course. After 2 weeks complete,

incomplete or no expulsion will be documented by trans
abdominal ultrasound.

Main Outcome Measure(s):

The expected primary outcome of this study is successful
expulsion of conception. The secondary outcome includes;
number of doses for successful expulsion, time interval between
first dose and spontaneous expulsion and side effects.

Statistical analysis:
Data will be processed manually and analyzed with the help of
SPSS (Statistical package for social sciences) Version 21.0.
Quantitative data will be expressed in mean and standard
deviation; and comparison will be done between the groups by "t"
test. Qualitative data will be expressed in frequency and
percentage; and comparison will be done between groups by Chi-
square (x2). A probability value of <0.05 (p<0.05) will be
considered statistically significant.

Ethical consideration
Approval of the protocol will be taken by the Institutional Ethical
Committee of ICMH, Matuail, Dhaka before the commencement of
the study. Informed written consent will be taken from each of the
patients before taking any interview. The attendant will be the
witness of taking informed consent. The consent form¦ will clearly
describe the purpose and methods of the study, confidentiality of
the interview, risks and benefits of participating in the study, their
rights to participate voluntarily and to refuse at any point of time
without consequences. All information will be collected
confidentially with complete respect to the patient’s wish and
without any force or mental pressure. This study will be done by
following the guideline of BMRC.
 4

Quality assurance strategy:

During the procedure of data collection, processing, and analysis,
a suggestion from a statistician will be sought and the collected
data will be rechecked to avoid entry of wrong data and to ensure
analysis using appropriate statistics.

Implementation of the result:

It is expected that this study will evaluate the effects of combined
mifepristone and misoprostol versus misoprostol alone for the
management of first trimester abortion. It will increase the
evidence-based knowledge about the effectiveness of these drugs
and will be helpful for the clinician to find an effective and safer
medical management of first trimester abortion.
Department of Obstetrics & Gynaecology,
7 Place of study
Institute of Child and Mother Health, Matuail, Dhaka.
8 Study Period Twelve months (after acceptance of protocol).
Overview of the study
9 Randomised Controlled Trial (RCT)
design
10 Introduction "Abortion is the termination of pregnancy by any means before the
foetus is sufficiently developed to survive. (Malhotra, N., et
al.2018)

First trimester abortion in one of the most common complication of

pregnancy occurring in 10-20% of clinically recognized
pregnancies. (Bagratee, J.S., et al.2004)
When Abortion occurs within 14 week of gestation is called First
trimester abortion. (Van den Berg, J., et al.2019)

There are two main type of First trimester Abortion Include

incomplete abortion and missed abortion that require medical
intervention. (Chu, J.J., et al.2020)
 5

A Missed abortion, also known as a delayed or silent abortion is

diagnosed when non-viable pregnancy is identified on USG scan
during first-14 weeks of gestation. Often women who have missed
abortion are asymptomatic or have small amount of vaginal
bleeding or pain before the diagnosis is made. All pregnancy
tissue is retained in the uterus in a missed abortion. By contrast
an incomplete abortion is diagnosed when pregnancy tissue have
been partly expelled by the uterus (Chu, J.J., et al.2020).

If women do not abort spontaneously they will undergo medical or

surgical treatment in order to remove the product of conception
from the uterus (Van den Berg, J., et al.2019).

According to ACOG (American college of obstetricians and

Gynecologists) & RCOG (Royal College of obstetricians and
Gynecologists) advantage of medical treatment is safe, effective
and acceptable alternative and it in used in off-label for several
obstetric and gynecologic indications (Van den Berg, et al.2019)
Disadvantage of medical treatment of first trimester abortion has
not yet gained wide acceptance (Stockheim, D., et al.2006).

For Many years, surgical evacuation was the standard

management of early pregnancy failure due to the low efficacy of
expectant management (47%) compared to surgical evacuation
(95%) (Wieringa-de Waard et al.2002) Mechanical dilatation of the
cervix followed by curettage is the most commonly used method
for termination of first trimester pregnancy. It remains as the
treatment of choice if bleeding is excessive and vital signs are
unstable, or infected tissue is present in the uterine cavity. Studies
suggest that 10% of women who miscarry fall into these
categories (Jabir, M., et al.2009).
 6

However, D & C is associated with risks of complications (Uterine

perforation, pelvic infection, excessive Bleeding, anesthesia, intra
uterine adhesions, cervical injury or cervical insufficiency in
following pregnancies) and high costs (Van den Berg, J., et
al.2019).

To decrease the rate of the complications many agents have been

investigated for their effectiveness in cervical priming action. The
most commonly used medical agents used are the prostaglandins
with or without the antiprogesterone agent (mifepristone) Ho, P.C.,
et al.1997), (Jabir, M., et al.2009).

Mifepristone in the only Anti progestin approved for the induction

of abortion. It in a 19 norsteroid which bind with high affinity to the
progesterone receptor thus inhibiting the effect of progesterone.
The blocking the progesterone receptors by mifepristone results in
vascular damage, decidual necrosis and bleeding which lead to
cervical softening, Increased uterine sensitivity to PG and
conversion of the quiet pregnant uterus into an organ of
spontaneous activity with maximal effect of 36-48 hours.
(Gemzell-Danielsson., et al.2008) For other indication such a
labour induction in case of fetal death after the first trimester and
also for the medical termination of vital pregnancy (Van den Berg,
J., et al.2019).

Misoprostol in a Synthetic PGE1 analogue which induces cervical

ripening as well as strong uterine contractions and leads to
expulsion of a pregnancy. (Gemzell-Danielsson., et al.2008) It is
also used for the prevention and treatment of peptic ulcer disease,
induction of labor at term (Sanchez-Ramos., et al.1997).

However, misoprostol in not always effective and 15-40% of

women require an additional dose of misoprostol, thus prolonging
the duration of treatment. To augment the effect of Misoprostol, a
 7

steroidal anti progesterone called mifepristone is sometimes used

in combination. The reported effectiveness of combination
treatment with mifepristone and misoprostol for the medical
management of first trimester abortion in proving previous clinical
trial has ranged from 64% to 84%(Chu, J.J., et al.2020).

But other studies showed that giving the antiprogesterone

mifepristone as pretreatment with misoprostol has not increased
the success rates substantially; 52-92%. (Davis, A.R., et al.2007),
(El-Refaey, H., et al. 1992). Due to these conflicting results this
study is designed to compare of outcome of combined
mifepristone and misoprostol with misoprostol alone in the
management of first trimester abortion, in order to have a ripe,
dilated cervix and expulsion of product of conception.
11 Rationale of the thesis Worldwide first trimester abortion is a very common phenomenon.
It includes incomplete abortion and missed abortion. Medicinal
abortion is performed with the help of the drugs mifepristone and
misoprostol. It has been shown in the past that the success rate is
lower when Misoprostol is used alone. Even more debate
surrounds the use of misoprostol alone. So, it became necessary
to investigate medical management options that would make
termination of a pregnancy in the first trimester more practical.

Although mifepristone was initially developed as a potential anti-

glucoccorticoid, its potent anti-progesterone activity quickly gained
prominence. Mifepristone has shown conclusively to increase the
success rate of abortions performed in the first trimester.
Mifepristone has also shown promising result that Its impact is
amplified when taken with misoprostol.

A prospective randomized control trial is needed to investigate the

effect of mifepristone and misoprostol combination in all type of
first trimester abortion. This study is designed to compare the
effectiveness of combined mifepristone and misoprostol with
 8

misoprostol alone in the management of first trimester abortion.

12 Research question/ Research question

hypothesis • Is combined mifepristone and misoprostol therapy more
(as applicable) effective than misoprostol alone in the management of first
trimester abortion?

Research hypothesis
• Combined mifepristone and misoprostol therapy is more
effective than misoprostol alone in the management of first
trimester abortion.
13 Objectives a) General Objective:
To determine the outcome of combined mifepristone and
misoprostol versus misoprostol alone in the management of
first trimester abortion.

b) Specific Objective:
1. To determine the proportion of patients having complete
spontaneous expulsion of conceptus treated with combined
mifepristone and misoprostol in the management of first
trimester abortion.

2. To determine the proportion of patients having complete

spontaneous expulsion of conceptus treated with misoprostol
in the management of first trimester abortion.

3. To identify the time interval between drug administration and

spontaneous expulsion of conceptus in patients of both groups
and compare the results between two groups.

4. To identify the side effects in patients treated with combined

mifepristone and misoprostol and misoprostol alone and
compare between two groups.
 9

14 Materials and methods a. Main outcome Outcome variables

variables Primary outcome
• Successful expulsion of
conception by Transabdominal
Sonography after 15 days

Secondary outcome
• Number of doses for successful
expulsion
• Time interval between first dose
and spontaneous expulsion

• Side effects

➢ Nausea
➢ Vomiting
➢ Diarrhea
➢ Severe pain
➢ Hyperpyrexia
➢ Excessive blood loss
b. Confounding • Age
variables • Parity
• Gestational age
c. Sample All patients with first trimester abortion.
d. Study Population All patients with first trimester abortion,
those will get admitted in Department of
Obstetrics and Gynaecology, Institute of
Child & Mother Health, Matuail Dhaka
for expulsion of the product of
conception and fulfilling the inclusion
and exclusion criteria will be enrolled as
study population.
 10

e. Sample size and Sample size calculation for RCT

the statistical 𝑝₁(100−𝑝₁)+𝑃₂ (100−𝑝₂)
n= × (𝑧⍺ + 𝑧𝛽)²
(𝑝₁−𝑝₂)²
basis of it

Where, n = sample size,

P 1 = outcome in experimental group

= 79.1% (Hamel et al., 2021)

P 2 = outcome in control group

= 58.7% (Hamel et al., 2021)

Z α = z- value of SND at a 20% level of significance, 80% c.

interval

=1.28

Z β = z- value of SND at 80% power

=0.84

So n= 44.02≈44 in each group

A total of (44+44) =88 patients will be enrolled in the study.

f. Screening Inclusion and exclusion criteria.
methods
g. Sampling Random sampling.
methods (s)
h. Inclusion and Inclusion criteria:
exclusion criteria • Women with first trimester abortion with a period of
gestation up to 14 weeks (Ultrasonography
diagnosis).
• Patient got at least one week of treatment.
• Haemodynamically stable women.
• Afebrile.
• Willingness and ability to sign the informed consent.
 11

Exclusion criteria:
• Patients age less than 16 years.
• Hemodynamic instability.
• Signs of infection.
• Contraindications for mifepristone or misoprostol.
• Potential interaction between study medication and
other medication.
• Known case of clotting disorder.
• Use of anticoagulants
• Presence of cardiovascular disease.
i. Operational Complete abortion:
definitions
When expulsion of gestational sac from the uterus, TED
15 mm by USG and no further evaluation is necessary is
called complete abortion.
Success: Abortion success is defined as complete abortion
without the use of surgical aspiration.
Failure: Abortion failure is defined as a need for evacuation
of the uterus by a surgical technique for any reason.

Induction expulsion interval: Time period between

commencements of treatment to expulsion of the
conceptus.
 12

j. Flow chart Flow chart of the steps of study:

showing the
Study population
sequence of tasks

Sample (n=88)

Participants
Randomization

Group-A (n=44) Group-B (n=44)

Data collection Data collection

Data Analysis Data Analysis

Results Results

Comparison

k. Procedures of Prior to data collection a semi-structured questionnaire and

preparing and check will be designed for this study by reviewing all the
organizing available questionnaire/data collection sheet of previous
materials studies along with the help of experts in this regards.
l. Nature of controls N/A
m. Randomization Lottery
and blinding
methods
Pre-designed and pretested semi-structured questionnaire
n. Equipment’s to be
and check list.
used
 13

o. Procedures of All patients in this study will be admitted to the Department

collecting data of Obstetrics and Gynecology, Institute of Child & Mother
Health, Matuail Dhaka. Detailed history, general, and
gynecological examinations will be carried out. The
demographic characteristics of each patient will be
assessed including age, body weight, gravidity, parity,
history of previous miscarriages, and gestational age that
will be determined by trans abdominal ultrasound.

Investigations will be conducted for each patient including

complete blood picture, renal function tests, liver function
tests,

Blood grouping. Rh typing and coagulation profile.

Informed written consent will be obtained from the patients

or guardians after full explanation of the purpose of the
study. They will be informed of their right to withdraw from
the study.
Eighty eight women with first trimester abortion satisfying
the inclusion and exclusion criteria will be selected in this
study.

Grouping of the sample:

Both of the group in this study will be selected by lottery.
Each patient/ guardian will be offered two sealed envelope
containing folded piece of paper bearing letter A or B and
will be requested to peak up one of these. Those who will
pick A will be selected for group-A and those who will pick B
will be selected for group-B.
 14

Intervention:
In Group A 200mg mifepristone will be given on empty
stomach in such a way that mifepristone will be placed
orally for half an hour than swallowed. After 24 to 48 hours
two doses of misoprostol 400µg will be given orally 4 hours
apart. In Group B only two doses of misoprostol 400µg will
be given orally, 4 hours apart. If no tissue is lost after 24
hours two more doses of oral misoprostol 400 µg (4 hour
apart) will be given, approximately 24 hours after the first
course. After 2 weeks, complete, incomplete or no
expulsion will be documented by trans abdominal
ultrasound.

Regular monitoring of patients for blood pressure, pulse,

temperature at 4 hourly interval will be carried out. Patients
will be observed for abdominal pain, uterine contractions
and vaginal bleeding. Rh-negative women will be given 150
microgm of anti D immunoglobulin. Surgical evacuation will
be performed in case of heavy vaginal bleeding or when
trans abdominal ultrasound did not document a complete
expulsion after 2 weeks.

The primary outcome evaluated will be drug induced

complete or incomplete evacuation.

Secondary outcome evaluated will patient satisfaction,

complications, side effects and costs.

All relevant findings will be recorded in a pre-designed data

collection sheet designed for the study.
p. Professional N/A
assistance form
experts (if
applicable)
 15

q. Procedure of data Data will be processed manually and analyzed with the help
analysis of of SPSS (Statistical package for social sciences) Version
interpretation 21.0.
Quantitative data will be expressed in mean and standard
deviation; and comparison will be done between the groups
by "t" test.
Qualitative data will be expressed in frequency and
percentage; and comparison will be done between groups
by Chi-square (x2).
A probability value of <0.05 (p<0.05) will be considered
statistically significant.
r. Quality assurance At the end of an interview a cross-check will be performed
strategy to detect and gather missed data.

Each completed datasheet will be coded at the end of each

working day.
Data collection sheet will be periodically checked by the
supervisor.
Regular entry of each fully completed questionnaire using
the SPSS programme.

In any critical situation, opinion will be taken from expert in

this regard
 16

s. Time table

1st month
11th to 12th
Activates 2nd to 10th month
month

Problem
definition

Literature
Review

Approach to
patients

Research
Design

Data
Collection

Data
Analysis

Report
writing &
binding

Submission
 17

15 Ethical implications Approval of the protocol will be taken by the Institutional Ethical
Committee of Institute of Child and Mother Health, Matuail, Dhaka
before the commencement of the study.

Informed written consent will be taken from each of the patients

before taking any interview. The attendant will be the witness of
taking informed consent. The consent form¦ will clearly describe the
purpose and methods of the study, confidentiality of the interview,
risks and benefits of participating in the study, their rights to
participate voluntarily and to refuse at any point of time without
consequences.

All information will be collected confidentially with complete respect

to the patient’s wish and without any force or mental pressure.

This study will be done by following the guideline of BMRC.

16 Total budget Cost of investigation Tk. 20,000.00
Internet search Tk. 2,000.00
Books and literature Tk. 3,000.00
Travelling Tk. 2,000.00
Data analysis and compose Tk. 30,000.00
Printing and binding Tk. 3000.00
Total Tk. 60,000.00
17 Source(s) of funding N/A
Facilities available at All investigations facilities are available at the place of study.
18
the place of study
 18

19 Other facilities
needed and the
organization N/A
(s)/institution (s)
providing them
20 Dissemination and Thesis will be submitted to BCPS which will be available in BCPS
use of the findings Library and with permission of BCPS results of the study may be
published in a reputed journal of the country or abroad.
21 References Abubeker, F.A., Lavelanet, A., Rodriguez, M.I. and Kim, C., 2020.
Medical termination for pregnancy in early first trimester (≤ 63 days)
using combination of mifepristone and misoprostol or misoprostol
alone: a systematic review. BMC women's health, 20(1), pp.1-17.
Bagratee, J.S., Khullar, V., Regan, L., Moodley, J. and Kagoro, H.,
2004. A randomized controlled trial comparing medical and
expectant management of first trimester miscarriage. Human
reproduction, 19(2), pp.266-271.
Chu, J.J., Devall, A.J., Beeson, L.E., Hardy, P., Cheed, V., Sun, Y.,
Roberts, T.E., Ogwulu, C.O., Williams, E., Jones, L.L. and
Papadopoulos, J.H.L.F., 2020. Mifepristone and misoprostol versus
misoprostol alone for the management of missed miscarriage
(MifeMiso): a randomised, double-blind, placebo-controlled
trial. The Lancet, 396(10253), pp.770-778.
Davis, A.R., Hendlish, S.K., Westhoff, C., Frederick, M.M., Zhang,
J., Gilles, J.M., Barnhart, K., Creinin, M.D. and National Institute of
Child Health and Human Development Management of Early
Pregnancy Failure Trial, 2007. Bleeding patterns after misoprostol
vs surgical treatment of early pregnancy failure: results from a
randomized trial. American journal of obstetrics and
gynecology, 196(1), pp.31-e1.
Dunford, A. and Fyfe, R., 2018. Combination therapy with
mifepristone and misoprostol for the management of first trimester
miscarriage: Improved success. Australian and New Zealand
Journal of Obstetrics and Gynaecology, 58(4), pp.438-442.
 19

El-Refaey, H., Hinshaw, K., Henshaw, R., Smith, N. and Templeton,

A., 1992. Medical management of missed abortion and
anembryonic pregnancy. BMJ: British Medical Journal, 305(6866),
p.1399.
Gemzell-Danielsson, K. and Lalitkumar, S., 2008. Second trimester
medical abortion with mifepristone–misoprostol and misoprostol
alone: a review of methods and management. Reproductive health
matters, 16(31), pp.162-172.
Hamel, C., Coppus, S., van den Berg, J., Hink, E., van Seeters, J.,
van Kesteren, P., Merién, A., Torrenga, B., van de Laar, R., van
Scheltinga, J.T. and Gaugler-Senden, I., 2021. Mifepristone
followed by misoprostol compared with placebo followed by
misoprostol as medical treatment for early pregnancy loss (the
Triple M trial): a double-blind placebo-controlled randomised
trial. EClinicalMedicine, 32, p.100716.
Ho, P.C., Ngai, S.W., Liu, K.L., Wong, G.C.Y. and Lee, S.W.H.,
1997. Vaginal misoprostol compared with oral misoprostol in
termination of second-trimester pregnancy. Obstetrics &
gynecology, 90(5), pp.735-738.
Jabir, M. and Smeet, R.I., 2009. Comparison of oral and vaginal
misoprostol for cervical ripening before evacuation of first trimester
missed miscarriage. Saudi medical journal, 30(1), pp.82-87.
Jain, J.K. and Mishell Jr, D.R., 1994. A comparison of intravaginal
misoprostol with prostaglandin E2 for termination of second-
trimester pregnancy. New England Journal of Medicine, 331(5),
pp.290-293.
Malhotra, N., Malhotra, J., Saxena, R. and Bora, N.M.,
2018. Jeffcoate's principles of gynaecology. JP Medical Ltd.
Nielsen, S., Hahlin, M. and PtetZrChristensen, J.J., 1997.
Unsuccessful treatment of missed abortion with a combination of an
antiprogesterone and a prostaglandin E1 analogue. BJOG: An
International Journal of Obstetrics & Gynaecology, 104(9), pp.1094-
1096.
Raymond, E.G., Shannon, C., Weaver, M.A. and Winikoff, B., 2013.
 20

First-trimester medical abortion with mifepristone 200 mg and

misoprostol: a systematic review. Contraception, 87(1), pp.26-37.
Sanchez-Ramos, L., Kaunitz, A.M., Wears, R.L., Delke, I. and
Gaudier, F.L., 1997. Misoprostol for cervical ripening and labor
induction: a meta-analysis. Obstetrics & gynecology, 89(4), pp.633-
642.
Stockheim, D., Machtinger, R., Wiser, A., Dulitzky, M., Soriano, D.,
Goldenberg, M., Schiff, E. and Seidman, D.S., 2006. A randomized
prospective study of misoprostol or mifepristone followed by
misoprostol when needed for the treatment of women with early
pregnancy failure. Fertility and sterility, 86(4), pp.956-960.
Van den Berg, J., Hamel, C.C., Snijders, M.P., Coppus, S.F. and
Vandenbussche, F.P., 2019. Mifepristone and misoprostol versus
misoprostol alone for uterine evacuation after early pregnancy
failure: study protocol for a randomized double blinded placebo-
controlled comparison (Triple M Trial). BMC pregnancy and
childbirth, 19(1), pp.1-8.
Van den Berg, J., van den Bent, J.M., Snijders, M.P., de Heus, R.,
Coppus, S.F. and Vandenbussche, F.P., 2014. Sequential use of
mifepristone and misoprostol in treatment of early pregnancy failure
appears more effective than misoprostol alone: a retrospective
study. European Journal of Obstetrics & Gynecology and
Reproductive Biology, 183, pp.16-19.
Wagaarachchi, P.T., Ashok, P.W., Narvekar, N., Smith, N.C. and
Templeton, A., 2001. Medical management of early fetal demise
using a combination of mifepristone and misoprostol. Human
Reproduction, 16(9), pp.1849-1853.
Wieringa-de Waard, M., Vos, J., Bonsel, G.J., Bindels, P.J. and
Ankum, W.M., 2002. Management of miscarriage: a randomized
controlled trial of expectant management versus surgical
evacuation. Human reproduction, 17(9), pp.2445-2450.
 21

Any other relevant N/A

22
information

23

I solemnly pledge that this research protocol shall be implemented in accordance with the
relevant ordinance/circulars of BCPS and funding agencies as and when it may be applicable.
I hereby declare that no part of the proposed research has been in any thesis/dissertation in
partial fulfillment of any degree/fellowship or in any publication.

I also understand that the BCPS reserves the right of accepting or rejecting this protocol.

…………………………… ……………………………………
Date Signature of the Researcher

24 Signature (s) of the supervisor (s)

 22

Dr. Dilruba Akter

Professor & Head of the Department
Obstetrics & Gynaecology
Director, ICMH
Institute of Child and Mother Health
Matuail, Dhaka.

Seal :

Attachment:

Appendix-I: Data collection sheet

Appendix-II: Informed written consent

 23

Appendix-I
Group A B
Data Collection Sheet

No. Reg. No: Date:

Name ....................................................................Age..........................Years

Address..........................................................................................................

Date & Time of admission...................................................................am/pm

1. Chief Complaints:

• Amenorrhoea for.....................
• Others.....................................

2. Obstetrics history:

a) Married for..........................Years

b) Gravida.........................

c) Para..............................

d) ALC.....................Years

3. Menstrual history:

a) Menstrual period ..........................

b) Menstrual cycle..........................

c) LMP ..........................

f) Contraceptive history..........................

4. Past obstetrics history of multipara patient. a) Vaginal delivery b)Instrumental delivery c) CS

5. History of medical disorder: Glucoma, Heart Disease, Sickle Cell Anemia, Seizure disorder, Alergy
to Postaglanding, Adrenal Disease.
 24

6. post surgical history:

7. Drug History:Cortico Steroid Yes / NO

Anti Coagulants Yes / NO

8. Patient’s condition at admission:

A) General Examination:

a) Anaemia..........................

b) Dehydration..........................

c) Oedema..........................

d) Pulse........................../min

e) BP....... .....................mm Hg

f) Temperature......................F

g) Respiratory rate............................/min

h) Lungs..........................

i) Heart..........................

B) Per Abdomen:

Uterus palpable / not palpable

Size of the uterus: weeks

C) Pelvic Examination:

Per Speculium:

Vagina:

Cervix:
 25

Abnormal discharge Internal OS Bleeding through OS Old tears

D) Per Vaginal Examination

Uterus Cervix Adnexa

Size Internal OS

Position Length

Shape Position

Mobility Consistency

Cnsistancy

9. Investigations:

CBC:

Hb:

Blood Grouping & Rh typing:

BT:

CT:

Platelet Count:

Sonographic findings..

10. Date and time administered mifepristone or misoprostol: ------------------------ & ------------------------

Successful expulsion of conceptus: complete/ Incomplete/No

Number of duces for successful expulsion :.....................

Time interval hetween first dose and spontaneous expulsion :.................................

Permeabilty of cervix in unsuccessful cases :.............................

 26

11. Side Effects

Side effects Yes NO

Nausea

Vomiting

Diarrhoea

Abdominal cramp

Severe pain:

Hyperpyrexia

Excessive blood loss:

Shivering

Unpleasant taste

Others:

12. Any maternal complication:

13. Blood transfusion

14. Patient discharge on: ...........................................

Pulse ......................../min

Bp ........................mm/Hg

Temperature ................F

Signature of Investigators

Date:
 27

Appendix-II

Informed Written Consent

1. Protocol ID:

2. Title of the study: Outcome of Combined Mifepristone and Misoprostol versus Misoprostol Alone in

the management of First Trimester Abortion

3. Investigator's name: Dr. Mst. Hazera khatun

4. Institution: Institute of Child and Mother Health, Matuail, Dhaka.

5. Do you know the type, purpose and procedure of this study? Yes/No

6. Are you sure that you will not face any physical, psychological and social risk for this study? Yes/No

7. Are you sure this study will not cause any physical or Psychological harm? Yes/No

8. Have you clear idea about the result and wellbeing of this study? Yes/No.

9. Do you have freedom to refuse, participate or help in this study? Yes/No.

10. Do you loss any fundamental human rights due to participation in this study? Yes? No.

11. Do you know that the confidentiality of your information will be maintained? Yes/No.

12. Do you know that you will get no remuneration or travel expenses due to participation

in this study? Yes/No.

 28

Informed consent Form

I am setting full information about the purpose, procedure and utility of this study, I give consent of

participate in this study. I have not been influenced by anybody or groups or my no mental human

rights have not been violated due to participation in this study. ssured that confidentiality of all

gathered information will be maintained and will be use only or study purpose and my personal

information will not be disclosed to others. My participation in this study is entirely voluntary. My

decision whether or not to participate will not prejudice my medical care. I have right to withdraw my

consent and discontinue participation at any time without prejudice to me or effect on my medical

care.

will have got no remuneration or travel expenses due to participation in this study.

I am willingly giving signature to this consent form.

Signature / Left thumb impression of Signature /Left thumb impression of

the participant the attendant/guardian

Signature / Left thumb impression of Signature of the investigator

withness Date.........................................
 29

অবহিতকরণ সম্মহতপত্র

1. প্রট োকল পহরহিহত নং-

2. গটবষণোর নোম: Outcome of combined mifepristone and misoprostol versus misoprostol

alone in the management of first trimester abortion.

3. গটবষটকর নোম: Dr. Mst. Hazera Khatun

4. প্রহতষ্ঠোটনর নোম: হিশু-মোতৃ স্বোস্থ্য ইন্সহ হ উ , মোতুযোইল, ঢোকো।

5. এই গটবষণো কটমের ধরন, উটেিয এবং পদ্ধহত সম্পটকে সম্পু নে জোনটত পপটরটেন হক ? িযোাঁ/নো

6. এই গটবষণোর জনয পে, আপনোটক িোহররীক, মোনহষক এবং সোমোহজক পকোন ঝুাঁহকর সম্মু খীন িটত িটব নো, এ

হবষটয হক হনহিত িটযটেন? িযোাঁ/নো

7. এই গটবষণোর ফটল আপনোর িরীর বো মটন পে পকোন ক্ষত বো আঘোত সৃ হি িটব নো এ হবষটয অবহিত িটযটেন

হক?িযোাঁ/নো

8. এই গটবষণোর ফলোফল এবং সম্ভোবয কলযোটনর হবষটয আপনোর ধোরণোহ স্পি িটযটে হক? িযোাঁ/নো

9. এই গটবষণো কটমে অংি গ্রিন, সিটেোহগতো দোন অথবো হবরত থোকোর হসদ্ধোত্ম আপহন স্বোধীন ভোটব গস্খিণ করটত

পোরটেন হক? িযোাঁ/নো

10. এই গটবষণো কটমে অংি গ্রিটনর ফটল আপনোর পমৌহলক মোনবোহধকোর ক্ষুন্ন িটযটে হক? িযোাঁ/নো

11. আপহন হক জোটনন আপনোর তথযোবলীর পগোপনীযতো বজোয রোখো িটব ? িযোাঁ/নো

12. এই গটবষণো কটমে অংি গ্রিটনর জনয আপনোটক পকোন প্রকোর পোহরশ্রহমক অথবো ভ্রমণ ভোতো পদযো িটব নো, এ

হবষটয অবহিত িটযটেন হক? িযোাঁ/নো

 30

সম্মহতপত্র

এই গটবষণো কটমের উটেিয, পদ্ধহত ও উপটেোহগতো সম্পটকে পূ ণে ধোরনো পোইযো এবং নীহতগত ববহিিয সমুটির প্রহত
আমোর সন্মহত প্রকোি কহরটতহে। গটবষণো কটমে অংিগ্রিটনর জনয আহম পকোন বযহি বো পগোহষ্ঠর দ্বোরো প্রভোহবত িয নোই
অথবো আনোর পমৌহলক মোনবোহধকোর ক্ষুন্ন িয নোই।

আহম হনহিন্ন িইযোহে পে, এই গটবষণো পথটক সংগৃ িীত তথযোবহল সম্পূ ণে পগোপন রোখো িইটব। এই তথযোবহল পকবলমোত্র
গটবষণোর কোটজই বযবিোর করো িইটব। আমোর বযহিগত তথযোহদ গটবষণোকোরী েোডো অনয কোরও হনক প্রকোি করো িইটব
নো।

আমোটক জোনোটনো িইযোটে পে, এই গটবষণোয অংিগ্রিন সম্পূ নে আমোর ইচ্ছোধীন। আহম ইচ্ছো কহরটল গটবষণোয অংিগ্রিণ
নোও কহরটত পোহর তোিোটত আমোর হিহকৎসোর তোরতময িইটব নো। পেটকোন মুিূটতে আহম আমোর সম্মহত প্রতযোিোর কহরবোর
অহধকোর রহন । তোমোর এই প্রতযোিোর/প্রতযোখযোন আমোর হিহকৎসোর উপর পকোনরূপ প্রভোব পফহলটব নো।

অতএব, েথোেথ পেেোটলোিনো সোটপটক্ষ আহন স্ব-প্রটনোহদত িইযো এই সম্মহত পটত্র স্বোক্ষর কহরটতহে।

অংিগ্রিনকোরীর স্বোক্ষর অথবো বোম বৃ দ্ধোঙ্গু লীর েোপ পরোগীর অহভভোবটকর স্বোক্ষর অথবো বোম বৃ দ্ধোঙ্গু লীর েোপ

স্বোক্ষীর স্বোক্ষর অথবো বোম বৃ দ্ধোঙ্গু লীর েোপ গটবষটকর স্বোক্ষর ও তোহরখঃ