Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

Phase 4

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

• Registration Number: NCT04217265
• 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.

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

Study Timeline

• Study First Submitted: 2019-12-30
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-01
• Last Update Submitted: 2020-01-01
• Study First Posted: 2020-01-03
• Last Update Posted: 2020-01-03
• 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.

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.
• Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Letrozole then misoprostol	2 tablets of Letrozole 2.5 mg will be given as single daily doses, 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 three doses.
control group	placebo then misoprostol	2 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 three doses

Primary Outcome Measures

Name	Time	Method
complete abortion rate	9 hours	Incidence of complete miscarriage
time from induction to abortion	9 hours	induction to abortion time interval

Secondary Outcome Measures

Name	Time	Method
Need for surgical evacuation of the products of conception	9 hours	how many women will undergo dilatation and curettage after failed medical induction of abortion