Medical Abortion With Single Daily Dose of Misoprostol

Phase 2

Completed

• Conditions: Miscarriage
• Interventions: Drug: Misoprostol

• Registration Number: NCT03487354
• Lead Sponsor: Ain Shams University

Brief Summary

Medical abortion using multiple vs single daily dose of misoprostol in first trimester miscarriage.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-25
• Study Start: 2018-04-01
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-04
• Status Verified: 2019-01
• Primary Completion: 2019-01-10
• Study Completion: 2019-01-10
• Last Update Submitted: 2019-01-26
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

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

Inclusion Criteria

• Maternal age more than 18 years old (age of legal consent).
• Gestational age less than 13 weeks.
• Hemoglobin >10 g/dL.
• BMI between 25 kg/m2 and 35 kg/m2.
• Missed abortion.
• Living fetus with multiple congenital malformations incompatible with life.

Exclusion Criteria

• Maternal age less than 18 years old.
• Gestational age more than 12 weeks.
• Hemoglobin <10 g/dL.
• Anencephaly.
• Fibroid uterus.
• BMI less than 25kg/m2 and more than 35kg/m2.
• Coagulopathy.
• History or evidence of adrenal pathology.
• Previous attempts for induction of abortion in the current pregnancy.
• Allergy to misoprostol or letrozole.
• Medical disorder that contraindicate induction of abortion (e.g. heart failure).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple daily doses	Misoprostol	-
Single daily dose	Misoprostol	-

Primary Outcome Measures

Name	Time	Method
Complete miscarriage	one week	Assessed by trans-vaginal ultrasound where endometrial thickness less than 15 mm is considered complete miscarriage

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt