Reducing the Need for In-Clinic Follow-Up for Medical Abortion in Moldova and Uzbekistan
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01410266|
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : December 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Medical Abortion, Fetus||Other: Alternative follow-up||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||2400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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 Start Date :||September 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
No Intervention: Standard of care
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.
Active Comparator: Alternative follow-up
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.
Other: Alternative follow-up
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.
- Continued, ongoing pregnancy [ Time Frame: 1 month ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410266
|Moldova, Republic of|
|The Perinatalogy Center|
|Balti, Moldova, Republic of|
|Municipal Clinical Hospital|
|Chisinau, Moldova, Republic of|
|The National Center of Reproductive Health and Medical Genetics|
|Chisinau, Moldova, Republic of|
|The Center of Women Health "Ana"|
|Drochia, Moldova, Republic of|
|Clinic #2 of Tashkent Medical Academy|
|Municipal Maternity House #10|
|Women's Wellness Center|
|Principal Investigator:||Hillary J. Bracken, PhD, MHS, MA||Gynuity Health Projects|
|Principal Investigator:||Beverly Winikoff, MD, MPH||Gynuity Health Projects|