Reducing the Need for In-Clinic Follow-Up for Medical Abortion in Moldova and Uzbekistan

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Medical Abortion, Fetus

Treatments: Other: Alternative follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT01410266

6.5

Details and patient eligibility

About

The purpose of this study is to determine whether an alternative method of follow-up after medical abortion is acceptable and feasible for use in Moldova and Uzbekistan.

Full description

Medical abortion using mifepristone and misoprostol is a highly effective procedure, but access to it may be impeded by the fact that not all women can afford or want to return for a follow-up visit. This often results in a high loss to follow-up rate. Additionally, with medical abortions of those women who do return for follow-up, higher costs are borne by both the woman and the healthcare system.

This study compares two methods of follow-up after medical abortion: standard of care versus alternative follow-up. The former involves a routine clinic visit two weeks after misoprostol administration. The latter consists of a low-sensitivity pregnancy test and a self-administered questionnaire. Based on the results of the test and questionnaire, women may be flagged as needing in-clinic follow-up or discharged from the study if their abortion is complete.

Enrollment: 2,400 patients

Sex: Female

Ages: 16 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Reproductive-age woman seeking a medical abortion
• Woman in good general health
• Woman with an intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
• Woman able and willing to sign consent forms
• Woman eligible for medical abortion according to clinician's assessment
• Woman agreeing to be followed up with, by phone or at a clinic visit

Exclusion criteria

• Woman with a pregnancy greater than 63 days gestation on the day of mifepristone administration

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,400 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Standard of care includes a routine clinic visit two weeks after misoprostol administration. At the clinic visit, the woman undergoes a bimanual examination. In the event the woman fails to return for the follow-up visit, clinic procedure is followed for contacting her to determine abortion status and the need for further intervention, if any.

Alternative follow-up

Active Comparator group

Description:

At a clinic visit, before mifepristone administration, the woman completes a semi-quantitative pregnancy test. After mifepristone administration, she is provided with another pregnancy test and a checklist to be self-administered two weeks after she takes misoprostol. On an assigned date, the woman is contacted by phone by the clinic staff and asked to report on the results of both tests. The provider then confirms whether, based on the woman's responses, she should return for a follow-up visit.

Treatment:

Other: Alternative follow-up