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Studying the feasibility and effectiveness of self-managed medication abortion

Studying Accompaniment model Feasibility and Effectiveness: a prospective, non-inferiority study of the effectiveness of self-managed medication abortion

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN95769543
Enrollment
1300
Registered
2019-08-15
Start date
2019-07-31
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self-managed medication abortion Pregnancy and Childbirth Medical abortion

Interventions

This study is a prospective, observational dynamic cohort study of people who contact safe abortion hotlines/accompaniment groups in Argentina, a country in Southeast Asia, and a country in West Afric

Sponsors

Ibis Reproductive Health
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Contacted the accompaniment group seeking information about induced abortion for their own pregnancy 2. At least 13 years of age 3. Able to give informed consent 4. Able to speak the local language 5. Meets accompaniment group eligibility criteria for starting medication abortion process (i.e. no known contraindications to medication abortion) 6. Starting a new medication abortion process

Exclusion criteria

Exclusion criteria: 1. Are experiencing ongoing symptoms (bleeding, cramping) from a previous abortion attempt prior to study enrollment 2. Have a known ectopic pregnancy or symptoms of an ectopic pregnancy 3. Do not want to share their contact information with study staff 4. Do not want to be contacted again by the hotline or by study staff 5. Are not willing to comply with study procedures 6. Cannot access a phone and private location to answer questions during follow-up

Design outcomes

Primary

MeasureTime frame
The proportion of participants with a complete abortion without the need for surgical evacuation is determined by the proportion of participants who report “yes” to the question “Do you feel that your abortion process is complete?” and who do not report any surgical intervention at first follow-up, second follow-up, and study end.

Secondary

MeasureTime frame
1. Signs of complication are determined using participant self-report of selected signs of complication at intervention at each follow-up. 2. Time to expulsion is determined using participant self-report of time from first medication dose to expulsion at each follow-up. 3. Ongoing pregnancy is determined using participant self-report of ongoing pregnancy at each follow-up. 4. Medical treatment/surgical intervention are determined using participant self-report at each follow-up. 5. The proportion of participants with complete abortion overall (with or without surgical evacuation) is determined using participant self-report at each follow-up.

Countries

Argentina

Contacts

Public ContactHeidi Moseson
hmoseson@ibisreproductivehealth.org+1-617-349-0040

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026