NCT00382538

Brief Summary

Mid-second trimester medical terminations of pregnancy require admission to the hospital for the length of time it takes a woman to abort. The current protocol at BMC uses intra-amniotic digoxin injection the day prior to admission. The following day, the woman is admitted and given sequential doses of misoprostol until delivery occurs. The average length of time between the first dose of misoprostol and delivery is 12 hours, requiring most women to stay overnight. This is a randomized, placebo-controlled, double-blinded study designed to determine whether adding mifepristone significantly reduces the induction interval time (time between starting the first misoprostol and delivery) required for a second trimester termination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

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

March 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

October 7, 2008

Status Verified

October 1, 2008

Enrollment Period

1.7 years

First QC Date

September 28, 2006

Last Update Submit

October 3, 2008

Conditions

Abortion, InducedAbortion, Second Trimester

Keywords

mifepristoneinductionabortioninjection, intra-amniotic

Outcome Measures

Primary Outcomes (1)

  • Time from start of induction to fetal delivery

Interventions

Addition of mifepristone 200 mg 24 hours before inductionDRUG

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age or over
  • able to give informed consent in English or Spanish
  • Requesting termination of pregnancy

You may not qualify if:

  • Under 16 years of age
  • rupture membranes or intrauterine death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • Kapp N, Borgatta L, Stubblefield P, Vragovic O, Moreno N. Mifepristone in second-trimester medical abortion: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1304-10. doi: 10.1097/01.AOG.0000289577.32274.a5.

    PMID: 18055725DERIVED

Study Officials

  • Lynn Borgatta, MD, MPH

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

March 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

October 7, 2008

Record last verified: 2008-10

Locations

US(1)