Clinical trial NCT01410266: Reducing the Need for In-Clinic Follow-Up for Medical Abortion in Moldova and Uzbekistan
Official title: The Acceptability and Feasibility of Reducing the Need for In-Clinic Follow-Up for First Trimester Medical Abortion in Moldova and Uzbekistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Medical Abortion, Fetus
Keywords: medical abortion
first trimester
follow-up
pregnancy test
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2011-08-05
Enrollment: 2400
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continued, ongoing pregnancy
timeFrame: 1 month
Secondary outcomes:
measure: Percentage of women who return for follow-up
timeFrame: 1 month
measure: Percentage of women receiving other treatment for ongoing pregnancy
timeFrame: 1 month
Other outcomes:
Locations:
city: Balti
country: Moldova, Republic of
facility: The Perinatalogy Center
city: Chisinau
country: Moldova, Republic of
facility: Municipal Clinical Hospital
city: Chisinau
country: Moldova, Republic of
facility: The National Center of Reproductive Health and Medical Genetics
city: Drochia
country: Moldova, Republic of
facility: The Center of Women Health "Ana"
city: Tashkent
country: Uzbekistan
facility: Clinic #2 of Tashkent Medical Academy
city: Tashkent
country: Uzbekistan
facility: Municipal Maternity House #10
city: Tashkent
country: Uzbekistan
facility: Women's Wellness Center
Study officials:
affiliation: Gynuity Health Projects
name: Hillary J. Bracken, PhD, MHS, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Platais I, Tsereteli T, Comendant R, Kurbanbekova D, Winikoff B. Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan. Contraception. 2015 Feb;91(2):178-83. doi: 10.1016/j.contraception.2014.11.004. Epub 2014 Nov 15.