Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage

Phase 4

• Conditions: Missed Abortion
• Interventions: Drug: letrozole then misoprostol; Drug: placebo then misoprostol

• Registration Number: NCT04215835
• Lead Sponsor: Cairo University

Brief Summary

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Last Update Submitted: 2019-12-30
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02
• Study Start: 2020-01-05
• Primary Completion: 2020-04-05
• Study Completion: 2020-04-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Gestational age less than 64 days gestation (<9 wks).
• Hemoglobin >10 g/dL.
• BMI between 18.5 kg/m2 and 25 kg/m2.
• Missed abortion.
• previous one or more cesarean delivaries

Exclusion Criteria

• Molar pregnancy.
• Fibroid uterus.
• Uterine anomalies.
• Coagulopathy.
• Medical disorder that contraindicate induction of abortion (e.g. heart failure).
• Previous attempts for induction of abortion in the current pregnancy.
• Allergy to misoprostol or letrozole.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	letrozole then misoprostol	3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.
control group	placebo then misoprostol	three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses

Primary Outcome Measures

Name	Time	Method
induction to abortion time	6 hours	induction to abortion time
Incidence of complete miscarriage	6 hours	Incidence of complete miscarriage

Secondary Outcome Measures

Name	Time	Method
Need for surgical evacuation of the products of conception	6 hours	Need for surgical evacuation of the products of conception