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

Induced Abortion Clinical Trial

Official title:

A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medication Abortion Using a Misoprostol-only Regimen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04242212
• Other study ID #: Ipas_NMAS
• Status: Recruiting
• Start date: May 19, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2020
• Source: Ipas
• Contact: Kristen M Shellenberg, PhD, MPH
• Phone: 1.310.733.6524
• Email: shellenbergk[@]ipas.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• First Trimester Abortion
• Induced Abortion

Intervention

Behavioral:
• Misoprostol sourced from clinics
One cohort of women using misoprostol sourced from clinics
• Misoprostol sourced from PMVs
One cohort of women using misoprostol sourced from PMVs

Locations

Country	Name	City	State
Nigeria	Multiple facilities	Abeokuta	Ogun
Nigeria	Multiple facilities	Awka	Anambra
Nigeria	Multiple facilities	Ibadan	Oyo

Sponsors (1)

Lead Sponsor	Collaborator
Ipas

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Uptake of postabortion contraception	Women's reported use of contraception (yes or no and method type) following medication abortion.	Final assessment at 45 days following misoprostol
Primary	Need for additional treatment to complete abortion	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.	Final assessment at 45 days following misoprostol
Secondary	Serious complications/ morbidity	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.	Final assessment at 45 days following misoprostol