The Feasibility of Simplified Telephone Follow-up After Medical Abortion

NCT00619658 | Completed DMC

• 1 other identifier: PRO07080379
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Induced Abortion

Keywords

telephone follow-up; medical abortion; induced abortion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To determine if a standardized set of questions can predict pregnancy expulsion, and to determine which method of misoprostol administration women prefer.

  four months

Study Arms (1)

1

EXPERIMENTAL

All women undergoing medical abortion will have telephone follow-up approximately one week after using mifepristone and misoprostol.

Other: telephone follow-up

Interventions

telephone follow-up OTHER

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Center for Family Planning Research, Magee-Womens Hospital, University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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. doi: 10.1016/j.contraception.2004.04.005.

  PMID: 15451336 BACKGROUND

Related Links

• Center for Family Planning Research website

Study Officials

• Lisa K Perriera, MD

  Center for Family Planning Research, University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

US (1)