Trial Outcomes & Findings for Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion (NCT NCT01436266)

Results Overview

500 cc or more

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

3 participants

Primary outcome timeframe

one day following the procedure

Results posted on

2017-05-30

Participant Flow

Eligible women will be identified by the clinician caring for the patient who will mention the study. If interested research staff will describe the study in detail and obtain consent from interested patients. The clinician who cares for the patient, and the physician who does the abortion procedure, will not be involved in the research procedures.

Three subjects were consented, one of which was ineligible after consent because she had spontaneous rupture of amniotic membranes prior to the abortion procedure. The other two subjects were enrolled.

Participant milestones

Participant milestones
Measure	Active Comparator: Misoprostol 400 mcg buccally 2 hours prior to procedure	Placebo Comparator: Placebo (Folic Acid) Two 1-mg tablets buccally 2 hours prior to procedure
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Comparator: Misoprostol n=1 Participants 400 mcg buccally 2 hours prior to procedure	Placebo Comparator: Placebo (Folic Acid) n=1 Participants Two 1-mg tablets buccally 2 hours prior to procedure	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Placebo Comparator: Placebo (Folic acid) · Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Placebo Comparator: Placebo (Folic acid) · Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: one day following the procedure

500 cc or more

Outcome measures

Outcome measures
Measure	Active Comparator: Misoprostol n=1 Participants 400 mcg buccally 2 hours prior to procedure	Placebo Comparator: Placebo (Folic Acid) n=1 Participants Two 1-mg tablets buccally 2 hours prior to procedure
Blood Loss	0 Participants	0 Participants

Adverse Events

Misoprostol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo (Folic Acid)

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

Sarita Sonalkar, MD

Boston Medical Center

Phone: 617 414 7304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place