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

Nishtar Medical University

Status and phase: Enrolling; Phase 4

Conditions: Miscarriage in First Trimester; Missed Miscarriage

Treatments: Drug: Placebo; Drug: Misoprostol (given vaginally); Drug: Letrozole 5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07160855

U1111-1327-5077

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Misoprostol with placebo

Active Comparator group

Description:

Vaginal Misoprostol will be instituted after oral placebo

Treatment:

Drug: Misoprostol (given vaginally)

Drug: Placebo

Misoprostol with Letrozole

Experimental group

Description:

After oral letrozole, vaginal Misoprostol will be instituted

Treatment:

Drug: Letrozole 5 mg

Drug: Misoprostol (given vaginally)