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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternative follow-up | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Continued, ongoing pregnancy | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of women who return for follow-up | 1 month | |
| Percentage of women receiving other treatment for ongoing pregnancy | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hillary J. Bracken, PhD, MHS, MA | Gynuity Health Projects | Principal Investigator |
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Perinatalogy Center | Bălţi | Moldova | ||||
| Municipal Clinical Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25497383 | Derived | 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. |
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| Chisinau |
| Moldova |
| The National Center of Reproductive Health and Medical Genetics | Chisinau | Moldova |
| The Center of Women Health "Ana" | Drochia | Moldova |
| Clinic #2 of Tashkent Medical Academy | Tashkent | Uzbekistan |
| Municipal Maternity House #10 | Tashkent | Uzbekistan |
| Women's Wellness Center | Tashkent | Uzbekistan |