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

S

St. Paul's Hospital Millennium Medical College, Ethiopia

Status

Completed

Conditions

Termination of Pregnancy

Treatments

Procedure: Dilation and evacuation

Study type

Interventional

Funder types

Other

Identifiers

NCT04602052
StPaulsHMM

Details and patient eligibility

About

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

Full 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.

Enrollment

279 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

279 participants in 2 patient groups

Medical arm
Active Comparator group
Description:
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.
Treatment:
Procedure: Dilation and evacuation
Surgical arm
Experimental group
Description:
Those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion.
Treatment:
Procedure: Dilation and evacuation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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