Effectiveness of Pretreatment Letrozole Versus Misoprostol Alone in Missed Abortion
Status:
Not yet recruiting
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
Background and Rationale Abortion accounts for about 8% of maternal mortality worldwide.
Surgical intervention is the definitive treatment for abortion but it is invasive.
Misoprostol, a PG E1 analogue, is exten¬sively used for induction of abortion with success
rate less than 90%. Estrogen is important in the maintenance of pregnancy & aromatase enzyme
is essential for its production. Letrozole is an aromatase inhibitor. So we assume that
suppression of serum estradiol by letrozole will facilitate termination of pregnancy.
Objectives :
To compare the effect of a combination of letrozole with misoprostol versus misoprostol alone
in successful induction of medical abortion.
Study population & Sample size 150 women will be recruited. Women included will be > 18 years
with singleton pregnancy of gestational age ≤ 20 weeks having missed abortion. They will be
excluded if they have prior CS, twin pregnancy, allergy to letrozole or liver problems.
Study Design :
A randomized controlled trial in which patients will be divided into 2 groups; case group &
control group. Each group will contain 75 patients.
Methods :
Case group will receive pretreatment letrozole 12.5 mg for 2 days while control group will
receive only misoprostol. Both groups will receive misoprostol in a dosage according to the
ACOG guidelines based on gestational age.
Possible Risk (s) to study population :
Major risks (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or
necessitating blood transfusion). Minor risks (Nausea, diarrhea, headache, weakness, hot
flushes).
Outcome parameter (s):
Successful medical abortion i.e. complete abortion with no need for surgical curettage within
one week from the 1st dose of misoprostol.