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

Termination of Pregnancy Clinical Trial

Official title:

Comparison of Surgical Versus Medical Termination of Pregnancy Between 13-20 Weeks of Gestation in Ethiopia: A Quasi-experimental Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602052
• Other study ID #: StPaulsHMM
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Termination of Pregnancy

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