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International Journal of Clinical Obstetrics and Gynaecology 2018; 2(6): 78-82
ISSN (P): 2522-6614
ISSN (E): 2522-6622
© Gynaecology Journal
www.gynaecologyjournal.com
2018; 2(6): 78-82
Received: 04-09-2018
Accepted: 08-10-2018
Rupali Modak
Assistant Professor, Dept of
Obstetrics and Gynecology, R.G.
Kar Medical College, Kolkata,
West Bengal, India
Subrata Roy
Junior Resident, Dept of Obstetrics
and Gynecology, Burdwan Medical
College, Burdwan, West Bengal,
India
Dilip Kumar Biswas
Assistant Professor, Dept of
Obstetrics and Gynecology,
Burdwan Medical College,
Burdwan, West Bengal, India
Amitava Pal
Professor, Dept of Obstetrics and
Gynecology, Burdwan Medical
College, Burdwan, West Bengal,
India
Tapan Kumar Mandal
Professor, Dept of Obstetrics and
Gynecology, Burdwan Medical
College, Burdwan, West Bengal,
India
Correspondence
Subrata Roy
Junior Resident, Dept of Obstetrics
and Gynecology, Burdwan Medical
College, Burdwan, West Bengal,
India
Role of combination of mifepristone and misoprostol
versus misoprostol alone in induction of labor in late
intrauterine fetal death: A randomized trial
Rupali Modak, Subrata Roy, Dilip Kumar Biswas, Amitava Pal and Tapan
Kumar Mandal
Abstract
Objectives: To compare the efficacy, safety of a combination of mifepristone and misoprostol with oral
misoprostol alone for induction of labor in late IUFD cases.
Methods: A hospital based prospective randomized comparative study over 120 pregnant women with
IUFD after 28 weeks of gestation requiring induction of labor for termination of pregnancy. Women were
divided into two groups. Women of group1 (n=63) received a single oral dose of 200 mg of mifepristone,
and after 24 hours, 50 mcg of intravaginal misoprostol was administered followed by 50 mcg of
intravaginal misoprostol at 6 hours interval for a maximum of 5 doses if required. For group 2 (misoprostol
alone group, n=57) received only misoprostol in the dose of 50 mcg intravaginally every 6 hours for a
maximum of 5 doses (5x50 mcg=250 mcg in 24hours).Primary outcome was measured by the rate of
successful delivery in 24 hours and induction delivery interval from first dose of misoprostol to complete
delivery of fetus and placenta.
Results: Successful delivery occurred within 24 hours, who received mifepristone before misoprostol than
misoprostol alone (94% versus 81%; difference12.95%; 95% CI, 1.07%-24.83%). Mean induction delivery
interval in combined regime (group 1) and misoprostol only regime(group 2) was 12.45h (95% CI of mean,
10.863h-14.038h) and 20.25h (95% CI of mean,18.284h-22.216h) respectively; P=0.0001. Mean dose of
misoprostol required in group 1 was 2.41± 1.19 and 3.67± 1.07 in group 2 (P=0.0001).With respect to side
effects, the two groups did not differ significantly.
Conclusions: Addition of mifepristone to misoprostol appears to be more effective than misoprostol alone
for induction of labor in late IUFD cases but both the regimens were equally safe, easy to administer and
affordable.
Keywords: mifepristone, misoprostol, intrauterine fetal death, induction of labor
Introduction
Intrauterine fetal death is one of the most devastating obstetric complications. A clinically
accepted definition of IUFD is the death of fetus at or after 20 weeks of pregnancy
[1]
, but for
international comparison WHO has now recommended IUFD as a baby born with no sign of life
at or after 28 weeks of gestation
[2]
. The loss of a wanted baby at any gestational age is
distressing not only to the expectant parents, but also to their relatives and attending obstetrician.
Despite improvement of medical facilities, pregnancy wastage still occurs at an unacceptably
high rate. Common causes of IUFD include maternal systemic illness such as diabetes mellitus
and hypertension and fetal causes such as infection, immune haemolytic disease, cord accidents,
metabolic disorders, malformation and placental dysfunction
[3]
.
As over 90% of women with IUFD deliver spontaneously within 3 weeks of the event. Until
then the retention of dead fetus could cause emotional distress and intrauterine infection
following rupture of membrane
[4]
. About one in four women with a dead fetus retained for 4
weeks or more may develop consumptive coagulopathy
[3]
. To reduce these complications
medical induction is recommended, if it is considered safe
[4]
. The ideal drug for termination of
pregnancy should not only be effective and safe but should be affordable to avoid financial
burden to the patients. Induction by oxytocin was widely used in the past, but it was less
successful as the uterus is less sensitive to oxytocin before term. RCOG in its green top guide
line No.55 endorsed a combination of mifepristone and a prostaglandin preparation as the first
line of intervention for induction of labor in IUFD, which is also recommended by NICE
guidelines especially for late IUFD cases
[5, 6]
. WHO recommends oral or vaginal misoprostol for
induction of labor in the third trimester of pregnancy in women with dead or malformed fetus
[7]
.