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
|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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|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|
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
- 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.
- 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.
- Uptake of postabortion contraception [ Time Frame: 30 days ]Women's reported use of contraception (yes or no and method type) following medical abortion
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
|Contact: Nathalie Kapp, MD, MPHemail@example.com|
|Contact: Erin Pearson, PhD, MPHfirstname.lastname@example.org|
|University of Health Sciences||Recruiting|
|Phnom Penh, Cambodia|
|Contact: Saphonn Vonthanak, MD, MSc PhD email@example.com|
|Contact: Bunsoth Mao, PhD +8184.108.40.206.888 firstname.lastname@example.org|
|Regional Institute for Population Studies||Not yet recruiting|
|Contact: Ayaga Bawah, PhD +233302500274 email@example.com|
|Principal Investigator:||Nathalie Kapp, MD, MPH||Ipas|