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Study of Clinic-based Versus Self-use of Medical Abortion Pills (MOC)

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ClinicalTrials.gov Identifier: NCT03727308
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
University of Health Science, Phnom Penh, Cambodia
Information provided by (Responsible Party):
Ipas

Brief Summary:
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.

Condition or disease Intervention/treatment
Induced Abortion First Trimester Abortion Misoprostol Mifepristone Behavioral: Medical abortion pills sourced from pharmacies Behavioral: Medical abortion pills sourced from health clinics

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medical Abortion Using Mifepristone With Misoprostol
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : January 30, 2021

Group/Cohort Intervention/treatment
Women recruited from pharmacies

Investigators will enroll women seeking medical abortion pills without prescription from pharmacies.

- Medical abortion pills sourced from pharmacies

Behavioral: Medical abortion pills sourced from pharmacies
One cohort using medical abortion pills sourced from pharmacies

Women recruited from health clinics

Investigators will enroll women seeking medical abortion pills from clinics.

- Medical abortion pills sourced from health clinics

Behavioral: Medical abortion pills sourced from health clinics
One cohort using medical abortion pills sourced from health clinics




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Uptake of postabortion contraception [ Time Frame: 30 days ]
    Women's reported use of contraception (yes or no and method type) following medical abortion



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women who are pregnant and seeking abortion in study sites.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727308


Contacts
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Contact: Nathalie Kapp, MD, MPH +1.919.960.5611 kappn@ipas.org
Contact: Erin Pearson, PhD, MPH +1.254.624.6937 pearsone@ipas.org

Locations
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Cambodia
University of Health Sciences Recruiting
Phnom Penh, Cambodia
Contact: Saphonn Vonthanak, MD, MSc PhD       vonthanak@uhs.edu.kh   
Contact: Bunsoth Mao, PhD    +855.97.60.61.888    maobunsoth@uhs.edu.kh   
Ghana
Regional Institute for Population Studies Not yet recruiting
Accra, Ghana
Contact: Ayaga Bawah, PhD    +233302500274    aabawah@ug.edu.gh   
Sponsors and Collaborators
Ipas
University of Health Science, Phnom Penh, Cambodia
Investigators
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Principal Investigator: Nathalie Kapp, MD, MPH Ipas

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Responsible Party: Ipas
ClinicalTrials.gov Identifier: NCT03727308     History of Changes
Other Study ID Numbers: 0916 NECHR
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ipas:
medical abortion
self-use
Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications