The Feasibility of Simplified Telephone Follow-up After Medical Abortion (SMART)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Feasibility of Simplified Telephone Follow-up After Medical Abortion|
- To determine the rate of completion of telephone interviews after medical abortion, and the rate of return for follow-up if necessary. [ Time Frame: four months ] [ Designated as safety issue: No ]
- To determine if a standardized set of questions can predict pregnancy expulsion, and to determine which method of misoprostol administration women prefer. [ Time Frame: four months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
All women undergoing medical abortion will have telephone follow-up approximately one week after using mifepristone and misoprostol.
Other: telephone follow-up
subjects undergoing medical abortion will recieve a telephone call and be asked a series of clinical questions. Expulsion of the pregnancy will be assessed based on the answers to those questions.
This is a prospective trial to evaluate the feasibility of performing a telephone interview to predict if pregnancy expulsion has occurred. In those women for whom expulsion has not been predicted to have occurred, the trial will evaluate if they will present for a follow-up visit. We plan to recruit 154 women that desire a medical abortion from Magee-Womens Hospital, Planned Parenthood of Western Pennsylvania, and private offices in the surrounding area. Women who are no more than 63 days gestation will receive mifepristone 200mg and misoprostol 800mcg. Each subject will choose between two evidence-based methods of using the misoprostol: buccally 24-72 hours or vaginally 0-72 hours after mifepristone. A follow-up phone call with a clinician will occur 5-9 days after mifepristone administration. Based on clinical history, including a structured question set, the subject and the clinician will predict if expulsion occurred. If either or both feel that expulsion may not have occurred, the women will return for follow-up in the office within one week for sonographic evaluation. If they both predict that expulsion has occurred at this initial phone call follow-up, the subject will perform a urine pregnancy test at home in approximately 3 weeks. She will have a follow-up phone call after the pregnancy test to obtain the results. The subject will only have an additional visit and ultrasound examination if the urine pregnancy test is positive.
The primary outcome is the percentage of women that will be available for follow-up over the phone, and/or return visit if necessary. The secondary outcomes are to determine if a standardized set of questions of clinical history after medical abortion will be useful to predict expulsion of the pregnancy and which mode of misoprostol administration women prefer. In addition, the study will confirm if women and clinicians are accurate at predicting expulsion of the pregnancy, compare the ability of patients and clinicians to predict expulsion of the pregnancy, determine how many women require follow-up evaluation after a telephone interview, and to determine the pregnancy continuation rate after misoprostol and mifepristone in this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619658
|United States, Pennsylvania|
|Center for Family Planning Research, Magee-Womens Hospital, University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Lisa K Perriera, MD||Center for Family Planning Research, University of Pittsburgh|