Study of Clinic-based Versus Self-use of Medical Abortion Pills

Induced Abortion Clinical Trial

— MOC  

Official title:

A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medical Abortion Using Mifepristone With Misoprostol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727308
• Other study ID #: 0916 NECHR
• Status: Completed
• Start date: May 30, 2018
• Est. completion date: June 2, 2021

Study information

• Verified date: September 2021
• Source: Ipas
• Contact: n/a
• 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 combined medical abortion regimen from a pharmacy when compared with those who access it from a facility.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4196
• Est. completion date: June 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• First Trimester Abortion
• Induced Abortion
• Mifepristone
• Misoprostol

Intervention

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

Locations

Country	Name	City	State
Cambodia	University of Health Sciences	Phnom Penh
Ghana	Regional Institute for Population Studies	Accra

Sponsors (2)

Lead Sponsor	Collaborator
Ipas	University of Health Science, Phnom Penh, Cambodia

Countries where clinical trial is conducted

Cambodia,  Ghana, 

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 medical abortion	30 days
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) following a woman taking the medical abortion pills.	Final assessment at 30 days following mifepristone administration
Secondary	Serious complications/ morbidity	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.	Final assessment at 30 days following mifepristone administration