Midlevel Versus Physician-provided Medical Abortion in the Second Trimester

NCT04181541 | Completed

• 1 other identifier: PM23/146
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the safety and effectiveness of second trimester medical abortion when provided by nurse midwives compared with physicians. The study sample will be obtained from Michu Clinic, affiliated with St Paul's hospital, in Addis Ababa.

Conditions

Induced Abortion; Second Trimester Abortion; Medical Abortion; Health Personnel

Keywords

Midlevel provider

Outcome Measures

Primary Outcomes (1)

• Time to expulsion

  Time to expulsion of fetus after medical abortion regimen initiated

  Time (hours/minutes) from first dose of misoprostol until the fetus is expelled, up to 72 hours

Secondary Outcomes (5)

• Total number of misoprostol doses

  Time (hours/minutes) from first dose of misoprostol until the fetus and placenta are expelled, up to 72 hours

• Need for ultrasound to confirm gestational age

  At the time of eligibility for the abortion is assessed, need for confirmatory ultrasound recorded (up to 1 day)

• Need for intervention by a physician

  Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days)

• Serious complications/ morbidity

  Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days)

• Adverse events

  up to 7 days after discharge

Study Arms (2)

Women receiving abortion care by physicians

ACTIVE COMPARATOR

Patients who receive second trimester medical abortion care from a physician.

Procedure: Provider type: Physicians

Women receiving abortion care from midlevel providers

EXPERIMENTAL

Patients who receive second trimester medical abortion care from a midlevel provider.

Procedure: Provider type: Midlevel Providers

Interventions

Provider type: Physicians PROCEDURE

In this cohort, women will receive second trimester medical abortion care from physicians

Women receiving abortion care by physicians

Provider type: Midlevel Providers PROCEDURE

In this cohort, women will receive second trimester medical abortion care from midlevel providers.

Women receiving abortion care from midlevel providers

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give consent for participation
• Intrauterine pregnancy with confirmed gestational age \>13 weeks and \<20 weeks
• Presenting for induced abortion at Michu Clinic
• Speaker of Amharic or Oromo

You may not qualify if:

• Women unable to give consent for participation
• Gestational age \<13 or \>20 weeks
• Adolescents aged less than 16 years
• Women with an allergy to or contraindications to mifepristone or misoprostol
• Women with a history of more than one previous hysterotomy
• Women seeking treatment for incomplete abortion, intrauterine fetal demise, or postabortion care
• Women with chronic hypertension or adrenal failure
• Women on chronic steroid treatment

Sponsors & Collaborators

• Ipas: lead
• St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia: collaborator

Study Sites (1)

St. Paul's Hospital Millennium Medical College

Addis Ababa, Ethiopia

Location

Study Officials

• Nathalie Kapp, MD, MPH

  Ipas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators propose a randomized, controlled, non-inferiority study comparing management of medical abortion by either nurse midwives or physicians for women undergoing induced abortion at a gestational ages \> 13 weeks.

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 29, 2019
• Study Start: February 17, 2020
• Primary Completion: February 24, 2021
• Study Completion: March 3, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)