NCT00986921

Brief Summary

Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

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

First Submitted

Initial submission to the registry

September 23, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

December 2, 2013

Completed
Last Updated

January 31, 2014

Status Verified

December 1, 2013

Enrollment Period

1.4 years

First QC Date

September 23, 2009

Results QC Date

September 7, 2012

Last Update Submit

December 28, 2013

Conditions

Abortion

Keywords

Length of time for procedure to be completedNeed for additional dilationSubject satisfaction with procedure

Outcome Measures

Primary Outcomes (1)

  • Time for Completion of Procedure

    Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)

    Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.

Secondary Outcomes (2)

  • Assessment of Ease of Procedure by Operator

    It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.

  • Moderate or Severe Pain Overnight

    Overnight

Study Arms (2)

mifepristone

EXPERIMENTAL

women in the mifepristone are would take mifepristone 200 mg for cervical preparation the day before their procedure, and not have dilators inserted. In this group, the sstandard procedure of osmotic dilator insertion is NOT performed.

Drug: mifepristone 200 mg

Osmotic dilator insertion

ACTIVE COMPARATOR

Women assigned to this arm would have the standard procedure for cervical preparation, which is insertion of osmotic dilators the day before the abortion procedure

Device: osmotic dilator insertion

Interventions

mifepristone 200 mgDRUG

mifepristone would be given the day before the procedure

mifepristone
osmotic dilator insertionDEVICE

osmotic dilators (3-6) would be inserted as usual the day before the procedure

Osmotic dilator insertion

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women aged 18-45 having pregnancy termination at 14-16 weeks

You may not qualify if:

  • multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6.

    PMID: 22682721DERIVED

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

This study was completed as planned.

Results Point of Contact

Title
Director of Clinical Research
Organization
Boston University Department of Obstetrics and Gynecology
rstudy@bmc.org
617-414-5175

Study Officials

  • L B, MD, MPH

    Boston University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 30, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

January 31, 2014

Results First Posted

December 2, 2013

Record last verified: 2013-12

Locations

US(1)