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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Anonymous
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00619658
First received: February 8, 2008
Last updated: October 22, 2008
Last verified: October 2008

February 8, 2008
October 22, 2008
February 2008
November 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00619658 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Feasibility of Simplified Telephone Follow-up After Medical Abortion
The Feasibility of Simplified Telephone Follow-up After Medical Abortion

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Induced Abortion
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.
Experimental: 1
All women undergoing medical abortion will have telephone follow-up approximately one week after using mifepristone and misoprostol.
Intervention: Other: telephone follow-up
Rossi B, Creinin MD, Meyn LA. Ability of the clinician and patient to predict the outcome of mifepristone and misoprostol medical abortion. Contraception. 2004 Oct;70(4):313-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
139
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00619658
PRO07080379
Yes
Lisa Perriera, MD, University of Pittsburgh
University of Pittsburgh
Anonymous
Principal Investigator: Lisa K Perriera, MD Center for Family Planning Research, University of Pittsburgh
University of Pittsburgh
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP