RecruitingPhase 4NCT07160855

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


Sponsor

Nishtar Medical University

Enrollment

92 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

  • 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 Criteria2

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

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Interventions

DRUGMisoprostol (given vaginally)

800 micrograms of a single dose of vaginal misoprostol will be given

DRUGLetrozole 5 mg

10 mg oral letrozole for 3 days will be given

DRUGPlacebo

oral placebo for three days will be given


Locations(1)

Nishtar Medical University and Hospital

Multan, Punjab Province, Pakistan

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NCT07160855


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