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

NCT04602052 | Completed

• 1 other identifier: StPaulsHMM
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

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

Conditions

Termination of Pregnancy

Keywords

Dilation and evacuation; Second Trimester; Medical abortion; Ethiopia

Outcome Measures

Primary Outcomes (1)

• Composite complication rate

  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

  During the abortion procedure and within 2 weeks post procedure

Secondary Outcomes (1)

• Other serious maternal complications

  During the abortion procedure and within 2 weeks post procedure

Study Arms (2)

Medical arm

ACTIVE COMPARATOR

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.

Procedure: Dilation and evacuation

Surgical arm

EXPERIMENTAL

Those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion.

Procedure: Dilation and evacuation

Interventions

Dilation and evacuation PROCEDURE

Abortion is termination of pregannacy by evaccuating the uterus using either medical or surgical technique

Also known as: Medical abortion

Medical arm; Surgical arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• St. Paul's Hospital Millennium Medical College, Ethiopia: lead

Study Sites (1)

Saint Paul's Hospital Millennium Medical College

Addis Ababa, 1271, Ethiopia

Location

MeSH Terms

Conditions

Dilatation, Pathologic

Interventions

Dilatation

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 26, 2020
• Study Start: November 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Currently available

Locations

ET (1)