NCT07160855

Letrozole Plus Misoprostol Versus Misoprostol Alone for Treating Women With Missed Miscarriage

Comparison of Letrozole With Misoprostol Versus Misoprostol Alone in the Management of Missed Miscarriages

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Nishtar Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn whether adding the medicine letrozole to Misoprostol helps women have a complete abortion more often than using Misoprostol alone for the treatment of missed miscarriage (when a pregnancy has stopped developing but has not yet passed naturally). The main questions this study aims to answer are: 1. Does taking letrozole for 3 days before misoprostol increase the chance of a complete abortion compared to misoprostol alone? 2. Does the use of letrozole affect the time it takes for abortion to occur? Who can Join? i. Women up to 13 weeks of pregnancy (based on last menstrual period and confirmed by ultrasound) who have a missed miscarriage. ii. Only those with a single pregnancy are eligible. iii. Women with a previous cesarean section or uterine scar are not included. What Will Happen in the Study A total of 92 women will take part. Participants will be randomly assigned to one of two groups: Group A: Letrozole tablets once daily for 3 days, followed by one dose of vaginal misoprostol. Group B: Placebo tablets for maximum of 3 days, followed by one dose of vaginal misoprostol. Doctors will monitor whether the abortion is complete within 24 hours. If it is not, other medical procedures will be offered as needed. Products of conception will be examined to confirm abortion.

Conditions

• Miscarriage in First Trimester
• Missed Miscarriage

Interventions

Type	Name	Description
DRUG	Misoprostol (given vaginally)	800 micrograms of a single dose of vaginal misoprostol will be given
DRUG	Letrozole 5 mg	10 mg oral letrozole for 3 days will be given
DRUG	Placebo	oral placebo for three days will be given

Timeline

• Start date: 2025-05-13
• Primary completion: 2025-11-12
• Completion: 2025-11-12
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: Pakistan