Medical Abortion, Fetus
Conditions
Keywords
medical abortion, first trimester, follow-up, pregnancy test
Brief summary
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.
Detailed 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.
Interventions
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.
Sponsors
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continued, ongoing pregnancy | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of women who return for follow-up | 1 month |
| Percentage of women receiving other treatment for ongoing pregnancy | 1 month |
Countries
Moldova, Uzbekistan
Outcome results
None listed