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

Phase 2

• Conditions: Miscarriage; Missed Abortion
• Interventions: Drug: Letrozole 2.5mg; Drug: Placebo; Drug: Misoprostol

• Registration Number: NCT03628625
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Detailed Description

According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period

Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week

letrozole administration with misoprostol raises the rate of complete abortion

Hypothesis:

In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.

Study Timeline

• Study First Submitted: 2018-05-10
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-14
• Study Start: 2018-09-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-05
• Last Update Posted: 2018-10-09
• Primary Completion: 2018-12-05
• Study Completion: 2018-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

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	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.
Study group	Letrozole 2.5mg	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	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
Control group	Placebo	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
Incidence of complete miscarriage	6 hours

Secondary Outcome Measures

Name	Time	Method
Need for surgical evacuation of the products of conception	6 hours
Incidence of Septic Abortion	1 week

Trial Locations

Locations (1)

Ain Shams University, Maternity Hospital; 🇪🇬 Cairo, Egypt