NCT00120224

Brief Summary

This study will investigate the possibility that medical abortion using mifepristone and misoprostol - a safe, proven therapy for terminating early first trimester pregnancy - can be administered in a manner that is simpler and less costly than that routinely employed in the United States. The researchers hypothesize that:

  1. 1.Practitioners themselves, based on history and examination but without sonography, are able to dependably and correctly determine which patients are eligible for medical abortion and which patients either are not eligible or require further evaluation to determine eligibility.
  2. 2.Practitioners themselves, based on a symptom diary and low-sensitivity pregnancy test but without sonography, are able to dependably and correctly determine when a successful medical abortion has taken place and when referral for other possible outcomes should be made.
  3. 3.A symptom diary and low-sensitivity pregnancy test are safe and effective means of separating those women who could benefit from a follow-up visit from those who do not need one.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,410

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2005

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 15, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

June 30, 2005

Last Update Submit

April 25, 2007

Conditions

Medical Abortion

Keywords

MifepristoneMedical abortionUltrasound

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women presenting at study clinics for medical abortion who agree to complete home study card and return for follow-up visit

You may not qualify if:

  • Women presenting at study clinics for medical abortion who do not agree to participate in study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Planned Parenthood of San Diego and Riverside Counties

San Diego, California, 92108, United States

Location

Family Planning Associates Medical Group

Chicago, Illinois, 60630, United States

Location

Planned Parenthood of New York City

New York, New York, 10012, United States

Location

Related Publications (7)

  • Savitz DA, Terry JW Jr, Dole N, Thorp JM Jr, Siega-Riz AM, Herring AH. Comparison of pregnancy dating by last menstrual period, ultrasound scanning, and their combination. Am J Obstet Gynecol. 2002 Dec;187(6):1660-6. doi: 10.1067/mob.2002.127601.

    PMID: 12501080BACKGROUND

  • Taipale P, Hiilesmaa V. Predicting delivery date by ultrasound and last menstrual period in early gestation. Obstet Gynecol. 2001 Feb;97(2):189-94. doi: 10.1016/s0029-7844(00)01131-5.

    PMID: 11165580BACKGROUND

  • Mongelli M, Wilcox M, Gardosi J. Estimating the date of confinement: ultrasonographic biometry versus certain menstrual dates. Am J Obstet Gynecol. 1996 Jan;174(1 Pt 1):278-81. doi: 10.1016/s0002-9378(96)70408-8.

    PMID: 8572021BACKGROUND

  • Fielding SL, Schaff EA, Nam NY. Clinicians' perception of sonogram indication for mifepristone abortion up to 63 days. Contraception. 2002 Jul;66(1):27-31. doi: 10.1016/s0010-7824(02)00316-5.

    PMID: 12169378BACKGROUND

  • Barnhart KT, Simhan H, Kamelle SA. Diagnostic accuracy of ultrasound above and below the beta-hCG discriminatory zone. Obstet Gynecol. 1999 Oct;94(4):583-7. doi: 10.1016/s0029-7844(99)00347-6.

    PMID: 10511363BACKGROUND

  • Fiala C, Safar P, Bygdeman M, Gemzell-Danielsson K. Verifying the effectiveness of medical abortion; ultrasound versus hCG testing. Eur J Obstet Gynecol Reprod Biol. 2003 Aug 15;109(2):190-5. doi: 10.1016/s0301-2115(03)00012-5.

    PMID: 12860340BACKGROUND

  • Clark W, Bracken H, Tanenhaus J, Schweikert S, Lichtenberg ES, Winikoff B. Alternatives to a routine follow-up visit for early medical abortion. Obstet Gynecol. 2010 Feb;115(2 Pt 1):264-272. doi: 10.1097/AOG.0b013e3181c996f3.

    PMID: 20093898DERIVED

Related Links

Study Officials

  • Wesley Clark, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 15, 2005

Study Start

May 1, 2005

Study Completion

April 1, 2007

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

US(3)