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The Feasibility of Simplified Telephone Follow-up After Medical Abortion (SMART)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00619658
First Posted: February 21, 2008
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pittsburgh
  Purpose
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.

Condition Intervention
Induced Abortion Other: telephone follow-up

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Feasibility of Simplified Telephone Follow-up After Medical Abortion

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 139
Study Start Date: February 2008
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619658


Locations
United States, Pennsylvania
Center for Family Planning Research, Magee-Womens Hospital, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Lisa K Perriera, MD Center for Family Planning Research, University of Pittsburgh
  More Information

Additional Information:
Publications:
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00619658     History of Changes
Other Study ID Numbers: PRO07080379
First Submitted: February 8, 2008
First Posted: February 21, 2008
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by University of Pittsburgh:
telephone follow-up
medical abortion
induced abortion