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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04602052
Other study ID # StPaulsHMM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date October 31, 2019

Study information

Verified date October 2020
Source St. Paul's Hospital Millennium Medical College, Ethiopia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 279
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Dilation and evacuation
Abortion is termination of pregannacy by evaccuating the uterus using either medical or surgical technique

Locations

Country Name City State
Ethiopia Saint Paul's Hospital Millennium Medical College Addis Ababa

Sponsors (1)

Lead Sponsor Collaborator
St. Paul's Hospital Millennium Medical College, Ethiopia

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Other serious maternal complications Continued bleeding for more than two weeks, additional major surgery (laparotomy), and death. During the abortion procedure and within 2 weeks post procedure
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