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

Gynuity Health Projects2,400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

2,400

Conditions

Medical Abortion, Fetus

Interventions

Alternative follow-upOTHER

Alternative follow-up consists of a self-administered semi-quantitative pregnancy test designed to measure urine beta-hCG levels, and a self-administered questionnaire consisting of 7 questions. Results of both are reviewed by the provider to determine if in-clinic follow-up is needed.

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (7)

The Perinatalogy Center

Bălţi, Moldova

Municipal Clinical Hospital

Chisinau, Moldova

The National Center of Reproductive Health and Medical Genetics

Chisinau, Moldova

The Center of Women Health "Ana"

Drochia, Moldova

Outcomes

Primary Outcomes

Continued, ongoing pregnancy

Time frame: 1 month

Secondary Outcomes

Percentage of women who return for follow-up

Time frame: 1 month

Percentage of women receiving other treatment for ongoing pregnancy

Time frame: 1 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.