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Completed

NCT Number: NCT03727308

Study of Clinic-based Versus Self-use of Medical Abortion Pills

The goal of the study is to determine whether important clinical outcomes differ among women who access a combined medical abortion regimen from a pharmacy when compared with those who access it from a facility.

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Key information

Age range

15 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Health Sciences, Phnom Penh, Cambodia

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About this study

Medical abortion with mifepristone and misoprostol within the first 10 weeks of pregnancy is safe and highly effective. Investigators aim to assess whether self-use of early (<9 weeks) medical abortion using mifepristone with misoprostol results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medical abortion.

The investigators will prospectively recruit women who obtain medical abortion medication from pharmacies and clinics. Follow-up will occur by telephone during two phone calls within 30 days following the woman's abortion. A small number of adolescents will be recruited into a qualitative substudy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Women are eligible for participation if they have purchased abortion medications (mifepristone-misoprostol) independently at a pharmacy or received them from a clinic for an unwanted pregnancy at less than 9 weeks since her last menstrual period (LMP). She must meet the following criteria:

  • Be at least 15 years of age (may vary by country)
  • Have a known LMP of less than 9 weeks
  • No contraindications to medical abortion (list)
  • Willing and able to give informed consent
  • Have a mobile phone of which they are the independent user or be willing to be followed-up in person
  • Willing to be contacted with questions about her abortion by telephone (optional in-person visit) at 3, 10-14 and 30 days following initial contact.
  • Resident of country of study.

Exclusion criteria

  • Contraindications to mifepristone-misoprostol
  • Age <15

Treatment and study plan

Medical abortion pills sourced from pharmacies

Behavioral

One cohort using medical abortion pills sourced from pharmacies

Medical abortion pills sourced from health clinics

Behavioral

One cohort using medical abortion pills sourced from health clinics

Primary outcomes

  1. Need for additional treatment to complete abortion

    Time frame: Final assessment at 30 days following mifepristone administration

    The primary outcome of the study will be the need for additional treatment to complete the abortion (either aspiration or repeated misoprostol) following a woman taking the medical abortion pills.

Secondary outcomes

  1. Serious complications/ morbidity

    Time frame: Final assessment at 30 days following mifepristone administration

    Number of participants who will have a complication such as hemorrhage requiring a blood transfusion, hospitalization, serious infection and undiagnosed (at the time of mifepristone) ectopic pregnancy.

Other outcomes

  1. Uptake of postabortion contraception

    Time frame: 30 days

    Women's reported use of contraception (yes or no and method type) following medical abortion

Sponsors and collaborators

Lead sponsor

Ipas

Other

Collaborators

  • University of Health Science, Phnom Penh, Cambodia

Registry information

Official study title

A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medical Abortion Using Mifepristone With Misoprostol

Acronym: MOC

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2018
Registry last updated
Sep 5, 2021

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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