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Study of Clinic-based vs. Self-use of a Misoprostol-only Regimen for Induced Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242212
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : February 24, 2020
Sponsor:
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 misoprostol-only medication abortion regimen from a patent medicine vendor when compared with those who access it from a clinic.

Condition or disease Intervention/treatment
Induced Abortion First Trimester Abortion Behavioral: Misoprostol sourced from clinics Behavioral: Misoprostol sourced from PMVs

Detailed Description:

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

The investigators will prospectively recruit women who obtain misoprostol from patent medicine vendors and clinics. Follow-up will occur by telephone during three phone calls within 45 days of the first dose of misoprostol.

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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 Medication Abortion Using a Misoprostol-only Regimen
Actual Study Start Date : May 19, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Group/Cohort Intervention/treatment
Clinic-based
Women who get misoprostol from a clinic-based provider
Behavioral: Misoprostol sourced from clinics
One cohort of women using misoprostol sourced from clinics

PMV-based
Women who get misoprostol from a patent medicine vendor
Behavioral: Misoprostol sourced from PMVs
One cohort of women using misoprostol sourced from PMVs




Primary Outcome Measures :
  1. Need for additional treatment to complete abortion [ Time Frame: Final assessment at 45 days following misoprostol ]
    The primary outcome of the study will be the need for additional treatment to complete the abortion (either aspiration or repeated misoprostol >3 doses) following a woman taking the medication abortion pills.


Secondary Outcome Measures :
  1. Serious complications/ morbidity [ Time Frame: Final assessment at 45 days following misoprostol ]
    Number of participants who have a complication such as hemorrhage requiring a blood transfusion, hospitalization, serious infection and undiagnosed (at the time of misoprostol) ectopic pregnancy.


Other Outcome Measures:
  1. Uptake of postabortion contraception [ Time Frame: Final assessment at 45 days following misoprostol ]
    Women's reported use of contraception (yes or no and method type) following medication abortion.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Nigerian women, age 15-49, living in the study geography, who are pregnant and seeking a misoprostol-only regimen for medication abortion, either from a patent medicine vendor or a healthcare clinic/facility.
Criteria

Inclusion Criteria:

  • Purchased a misoprostol-only abortion regimen at a PMV or from a clinic
  • Be at least 15 years of age
  • Have a known LMP of less than 9 weeks
  • No contraindications to medical abortion
  • 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 at 1-3, 10-29 and 30-45 days following initial contact.

Exclusion Criteria:

  • Contraindications to misoprostol
  • Age <15 or >49

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): NCT04242212


Contacts
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Contact: Kristen M Shellenberg, PhD, MPH 1.310.733.6524 shellenbergk@ipas.org
Contact: Nathalie Kapp, MD, MPH 1.919.960.5611 kappn@ipas.org

Locations
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Nigeria
Multiple facilities Recruiting
Awka, Anambra, Nigeria
Multiple facilities Recruiting
Abeokuta, Ogun, Nigeria
Multiple facilities Recruiting
Ibadan, Oyo, Nigeria
Sponsors and Collaborators
Ipas
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Responsible Party: Ipas
ClinicalTrials.gov Identifier: NCT04242212    
Other Study ID Numbers: Ipas_NMAS
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
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:
Medication abortion
Misoprostol
Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics