The Feasibility of Simplified Telephone Follow-up After Medical Abortion

Study Overview
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Brief Summary
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To assess the feasibility of using simplified telephone follow-up to predict pregnancy expulsion after medical abortion, and if in-person follow-up is required to determine the percentage of women that will present for that follow-up.

Detailed Description
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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.

Official Title
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The Feasibility of Simplified Telephone Follow-up After Medical Abortion

Conditions
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Induced Abortion

Intervention / Treatment
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* Other: telephone follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy females requesting an elective termination of pregnancy by medical abortion an intrauterine pregnancy </= 63 days gestation willing and able to sign the informed consent willing to comply with the study protocol and visit schedule willing to have a surgical abortion/D&C if indicated with easy and ready access to a telephone Exclusion Criteria: contraindication to mifepristone contraindication to misoprostol cardiovascular disease -hemoglobin <10 g/dL known clotting defect or receiving anticoagulants pregnancy with an IUD breastfeeding ultrasound evidence of an early pregnancy failure pelvic examination with evidence of acute cervicitis prior participation in this research study current participation in a conflicting research study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All women undergoing medical abortion will have telephone follow-up approximately one week after using mifepristone and misoprostol. | Other: telephone follow-up<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the rate of completion of telephone interviews after medical abortion, and the rate of return for follow-up if necessary. |  | four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if a standardized set of questions can predict pregnancy expulsion, and to determine which method of misoprostol administration women prefer. |  | four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telephone follow-up, medical abortion, induced abortion