Comparison of Surgical Versus Medical Termination of Pregnancy Between 13-20 Weeks of Gestation in Ethiopia

Not Applicable

Completed

• Conditions: Termination of Pregnancy
• Interventions: Procedure: Dilation and evacuation

• Registration Number: NCT04602052
• Lead Sponsor: St. Paul's Hospital Millennium Medical College, Ethiopia

Brief Summary

The purpose of the study is to determine the safety and effectiveness of dilation and evacuation for surgical abortion as compared to medical abortion

Detailed Description

All patients with a gestational age between 13-20 weeks are fully counseled on the risks and benefits and given the option of medical or surgical abortion. Those who choose medical abortion receive mifepristone 200 mg on day 1 and are appointed to return to SPHMMC 24-48 hours later for admission and misoprostol administration. Those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion.

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2020-10
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-20
• Last Update Submitted: 2020-10-20
• Study First Posted: 2020-10-26
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 279

Inclusion Criteria

• Gestational age between 13 - 20 weeks confirmed with ultrasound,
• Age at or more than18 years,
• Having a working phone and willingness to be contacted for a follow-up questionnaire 2 weeks after the procedure.

Exclusion criteria

• Inability to give consent
• complicated abortion (missed abortion, septic abortion)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical arm	Dilation and evacuation	Those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion.
Medical arm	Dilation and evacuation	Those who choose medical abortion receive mifepristone 200 mg on day 1 and are appointed to return to SPHMMC 24-48 hours later for admission and misoprostol administration.

Primary Outcome Measures

Name	Time	Method
Composite complication rate	During the abortion procedure and within 2 weeks post procedure	Presence of one of the following complications: bleeding requiring observation, genital tract lacerations requiring repair, need for additional intervention to complete the abortion procedure, and one or more symptoms of pelvic infection

Secondary Outcome Measures

Name	Time	Method
Other serious maternal complications	During the abortion procedure and within 2 weeks post procedure	Continued bleeding for more than two weeks, additional major surgery (laparotomy), and death.

Trial Locations

Locations (1)

Saint Paul's Hospital Millennium Medical College; 🇪🇹 Addis Ababa, Ethiopia