Trial Outcomes & Findings for Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion (NCT NCT00855842)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

hours since the start of medical abortion

Results posted on

2011-07-08

Participant Flow

Women requesting abortion at 19-23 weeks were eligible to enroll if they were able to consent and had no contraindications to medical abortion. Women were informed of the study after all counseling for abortion was completed and after they had given consent for abortion

Women were eligible for study intervention if they had singleton pregnancy with intact membranes, without signs of infection.

Participant milestones

Participant milestones
Measure	Osmotic Dilator osmotic dilator
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Osmotic Dilator n=4 Participants osmotic dilator
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Age Continuous	27 years STANDARD_DEVIATION 5 • n=39 Participants
Sex: Female, Male Female	4 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=39 Participants
Region of Enrollment United States	4 participants n=39 Participants

PRIMARY outcome

Timeframe: hours since the start of medical abortion

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

Outcome measures

Outcome measures
Measure	Osmotic Dilator n=4 Participants osmotic dilator
Length of Medical Abortion	7 hours Standard Deviation 5

Adverse Events

Osmotic Dilator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lynn Borgatta, MD

Boston University

Phone: 617-414-3440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place