Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion

Phase 4

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

• Registration Number: NCT04590482
• Lead Sponsor: Shereen Rady Abou El-fetouh

Brief Summary

this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.

Detailed Description

Intervention type: drug

Intervention name: letrozole then misoprostol

Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion

Arm group label:study group

Intervention type :drug

Intervention name:placebo then misoprostol

Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion

Arm group label: control group

Study Timeline

• Study First Submitted: 2020-08-23
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-10
• Study First Posted: 2020-10-19
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29
• Study Start: 2020-11-15
• Primary Completion: 2021-03-16
• Study Completion: 2021-05-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

1. Maternal age more than 18 years old.
2. Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study.
3. Hemoglobin >10 g/dl
4. Missed abortion

Exclusion Criteria

1. Mullerian Uterine anomalies as septate, bicornuate uterus.

2. Fibroid uterus.

3. Coagulopathy.

4. Medical disorder that contraindicate induction of abortion.

5. Allergy to misoprostol or letrozole.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo then misoprostol	placebo	Description:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed
letrozole then misoprostol	letrozole	description:letrozole 2.5 mg each 12hours for 2 days at home followed by misoprostol 800mcg vaginally at hospital repeated after 4 hours if needed

Primary Outcome Measures

Name	Time	Method
Complete abortion	6 hours	incidence of complete abortion without the need of surgical evacuation among 110patients in which 55 of patients took letrozole before misoprostol and the other 55 patients took placebo before misoprostol

Secondary Outcome Measures

Name	Time	Method
surgical evacuation	6 hours	surgical evacuation for the remnants of conception among 110 patients in which 55 took letrozole before misoprostol and other 55 patients who took placebo before misoprostol