Actively Recruiting
Led by Nishtar Medical University · Updated on 2025-09-08
92
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating whether adding the medicine letrozole to misoprostol can help women have a complete abortion more often compared to using misoprostol alone for treating missed miscarriage, a condition where a pregnancy has stopped developing but has not passed naturally. The study focuses on women up to 13 weeks pregnant with a single pregnancy and excludes those with previous cesarean sections or uterine scars. This phase 4 trial aims to answer if taking letrozole for 3 days before misoprostol increases the chance of complete abortion and if it affects the time for abortion to occur. Participants will be randomly assigned to one of two groups. One group will take letrozole tablets orally once daily for 3 days, followed by a single dose of vaginal misoprostol. The other group will receive placebo tablets for up to 3 days before the vaginal misoprostol dose. The misoprostol dose is 800 micrograms given vaginally. Doctors will monitor the abortion progress closely within 24 hours after the medication to determine if the abortion is complete. During the study, 92 women will be monitored to see if the abortion completes within 24 hours after starting the study medication. If not complete, other medical procedures will be offered as needed. Researchers will examine products of conception to confirm the abortion. This careful monitoring helps understand the effects of adding letrozole to misoprostol for managing missed miscarriage and supports participant safety throughout the trial.
CONDITIONS
Letrozole Plus Misoprostol Versus Misoprostol Alone for Treating Women With Missed Miscarriage
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days
Participants receive oral letrozole or placebo for 3 days followed by a single vaginal dose of misoprostol for management of missed miscarriage.
1 baseline visit and 1 follow-up visit within 24 hours after treatment
Total: 1 location
1
Nishtar Medical University and Hospital
Multan, Punjab Province, Pakistan, 60000
Actively Recruiting
A
Afrayshum T Principal Investigator, MBBS
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Fatemeh Abbasalizadeh, Farnaz Sahhaf, Paria Sadeghi-Shabestari...
https://pubmed.ncbi.nlm.nih.gov/30647756