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

Not Applicable

Recruiting

• Conditions: Miscarriage in First Trimester; Missed Miscarriage
• Interventions: Drug: Misoprostol (given vaginally); Drug: Placebo; Drug: Letrozole 5 mg

• Registration Number: NCT07160855
• Lead Sponsor: Nishtar Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-13
• Status Verified: 2025-08
• Study First Submitted: 2025-08-29
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2025-11-12
• Study Completion: 2025-11-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

• Pregnant women up till 13th weeks of gestation according to last menstrual period (LMP) dates, confirmed on ultrasound
• Single intrauterine pregnancy
• Planned for termination due to missed miscarriage

Exclusion Criteria

• Previous history of cesarean section
• Uterine scar due to previous procedure like myomectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol with placebo	Misoprostol (given vaginally)	Vaginal Misoprostol will be instituted after oral placebo
Misoprostol with placebo	Placebo	Vaginal Misoprostol will be instituted after oral placebo
Misoprostol with Letrozole	Misoprostol (given vaginally)	After oral letrozole, vaginal Misoprostol will be instituted
Misoprostol with Letrozole	Letrozole 5 mg	After oral letrozole, vaginal Misoprostol will be instituted

Primary Outcome Measures

Name	Time	Method
Complete abortion	From start of study medication after randomization to within 24-hours	The expulsion of both fetus and placenta without operative intervention and no retained products of conception confirmed on ultrasound.

Trial Locations

Locations (1)

Nishtar Medical University and Hospital; 🇵🇰 Multan, Punjab Province, Pakistan