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

NCT ID: NCT04242212

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-19

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Induced Abortion First Trimester Abortion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinic-based

Women who get misoprostol from a clinic-based provider

Misoprostol sourced from clinics

Intervention Type BEHAVIORAL

One cohort of women using misoprostol sourced from clinics

PMV-based

Women who get misoprostol from a patent medicine vendor

Misoprostol sourced from PMVs

Intervention Type BEHAVIORAL

One cohort of women using misoprostol sourced from PMVs

Interventions

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Misoprostol sourced from clinics

One cohort of women using misoprostol sourced from clinics

Intervention Type BEHAVIORAL

Misoprostol sourced from PMVs

One cohort of women using misoprostol sourced from PMVs

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ipas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Multiple facilities

Awka, Anambra, Nigeria

Site Status RECRUITING

Multiple facilities

Abeokuta, Ogun State, Nigeria

Site Status RECRUITING

Multiple facilities

Ibadan, Oyo State, Nigeria

Site Status RECRUITING

Countries

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Nigeria

Central Contacts

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Kristen M Shellenberg, PhD, MPH

Role: CONTACT

1.310.733.6524

Nathalie Kapp, MD, MPH

Role: CONTACT

1.919.960.5611

Other Identifiers

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Ipas_NMAS

Identifier Type: -

Identifier Source: org_study_id

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