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

NCT ID: NCT04602052

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-10-31

Brief Summary

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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

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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.

Conditions

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Termination of Pregnancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medical arm

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.

Group Type ACTIVE_COMPARATOR

Dilation and evacuation

Intervention Type PROCEDURE

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

Surgical arm

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

Group Type EXPERIMENTAL

Dilation and evacuation

Intervention Type PROCEDURE

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

Interventions

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Dilation and evacuation

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

Intervention Type PROCEDURE

Other Intervention Names

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Medical abortion

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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St. Paul's Hospital Millennium Medical College, Ethiopia

OTHER

Sponsor Role lead

Responsible Party

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Tesfaye H. Tufa, MD

Assistant Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saint Paul's Hospital Millennium Medical College

Addis Ababa, , Ethiopia

Site Status

Countries

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Ethiopia

Other Identifiers

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StPaulsHMM

Identifier Type: -

Identifier Source: org_study_id