NCT00855842

Brief Summary

One the day prior to medical abortion (labor induction) in the second trimester, insertion of osmotic dilators is added to the routine procedures. The study is to see whether the addition of dilators decreases the abortion time (time for the pregnancy to be expelled)

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 8, 2011

Completed
Last Updated

July 8, 2011

Status Verified

June 1, 2011

Enrollment Period

10 months

First QC Date

March 2, 2009

Results QC Date

April 4, 2011

Last Update Submit

June 10, 2011

Conditions

Abortion, Induced

Keywords

second trimester abortionlabor induction abortionsecond trimester medical abortionpregnancy

Outcome Measures

Primary Outcomes (1)

  • Length of Medical Abortion

    This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus

    hours since the start of medical abortion

Study Arms (1)

osmotic dilator

EXPERIMENTAL

osmotic dilator

Device: osmotic dilator insertion

Interventions

osmotic dilator insertionDEVICE

osmotic dilators are placed in the cervix to cause cervical dilation

Also known as: laminaria, Dilapan
osmotic dilator

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Requesting abortion 19-23 weeks
  • No contraindication to induction abortion

You may not qualify if:

  • Fetal demise
  • Ruptured membranes
  • Evidence of pelvic infection
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Limitations and Caveats

The study was terminated early because the clinical facility changed and eligible patients were not seen at the facility.

Results Point of Contact

Title
Lynn Borgatta, MD
Organization
Boston University
lynn.borgatta@bmc.org
617-414-3440

Study Officials

  • Lynn Borgatta, 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 4, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 8, 2011

Results First Posted

July 8, 2011

Record last verified: 2011-06

Locations

US(1)