- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01410266
Reducing the Need for In-Clinic Follow-Up for Medical Abortion in Moldova and Uzbekistan
The Acceptability and Feasibility of Reducing the Need for In-Clinic Follow-Up for First Trimester Medical Abortion in Moldova and Uzbekistan
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Balti, Moldova, Republic of
- The Perinatalogy Center
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Chisinau, Moldova, Republic of
- Municipal Clinical Hospital
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Chisinau, Moldova, Republic of
- The National Center of Reproductive Health and Medical Genetics
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Drochia, Moldova, Republic of
- The Center of Women Health "Ana"
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Tashkent, Uzbekistan
- Clinic #2 of Tashkent Medical Academy
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Tashkent, Uzbekistan
- Municipal Maternity House #10
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Tashkent, Uzbekistan
- Women's Wellness Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Continued, ongoing pregnancy
Time Frame: 1 month
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1 month
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Percentage of women who return for follow-up
Time Frame: 1 month
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1 month
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Percentage of women receiving other treatment for ongoing pregnancy
Time Frame: 1 month
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hillary J. Bracken, PhD, MHS, MA, Gynuity Health Projects
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 6.5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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