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Completed

NCT Number: NCT01410266

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

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.

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Key information

Age range

16 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Perinatalogy Center, Bălţi, Moldova

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: semi-quantitative pregnancy test, self-administered questionnaire

Primary outcomes

  1. Continued, ongoing pregnancy

    Time frame: 1 month

Secondary outcomes

  1. Percentage of women who return for follow-up

    Time frame: 1 month

  2. Percentage of women receiving other treatment for ongoing pregnancy

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

The Acceptability and Feasibility of Reducing the Need for In-Clinic Follow-Up for First Trimester Medical Abortion in Moldova and Uzbekistan

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 5, 2011
Registry last updated
Dec 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.