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Completed

NCT Number: NCT04602052

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

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

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Key information

Conditions

Termination of Pregnancy Dilatation, Pathologic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Paul's Hospital Millennium Medical College

Addis Ababa, 1271, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dilation and evacuation

Procedure

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

Other names: Medical abortion

Primary outcomes

  1. Composite complication rate

    Time frame: 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 outcomes

  1. Other serious maternal complications

    Time frame: During the abortion procedure and within 2 weeks post procedure

    Continued bleeding for more than two weeks, additional major surgery (laparotomy), and death.

Sponsors and collaborators

Lead sponsor

St. Paul's Hospital Millennium Medical College, Ethiopia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2020
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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