Reducing the Need for In-Clinic Follow-Up for Medical Abortion in Moldova and Uzbekistan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01410266
First received: August 3, 2011
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Medical Abortion, Fetus
Other: Alternative follow-up
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Continued, ongoing pregnancy [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of women who return for follow-up [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Percentage of women receiving other treatment for ongoing pregnancy [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 2400
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • semi-quantitative pregnancy test
  • self-administered questionnaire

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

Ages Eligible for Study:   16 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410266

Locations
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
Uzbekistan
Clinic #2 of Tashkent Medical Academy
Tashkent, Uzbekistan
Municipal Maternity House #10
Tashkent, Uzbekistan
Women's Wellness Center
Tashkent, Uzbekistan
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Principal Investigator: Hillary J. Bracken, PhD, MHS, MA Gynuity Health Projects
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01410266     History of Changes
Other Study ID Numbers: 6.5
Study First Received: August 3, 2011
Last Updated: November 30, 2012
Health Authority: Moldova: Ministry of Health
Uzbekistan: Ministry of Health

Keywords provided by Gynuity Health Projects:
medical abortion
first trimester
follow-up
pregnancy test

ClinicalTrials.gov processed this record on July 22, 2014