Trial Outcomes & Findings for Intra Uterine Device Insertion in Nulliparous Women (NCT NCT01422226)

Results Overview

The primary outcome is the proportion in each group able to have the IUD inserted in a standard fashion without the ancillary measures of mechanical dilation of the cervix, placement of paracervical nerve block, or using abdominal ultrasound for guidance. The null hypothesis for the primary outcome is that misoprostol does not influence difficulty of insertion.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

During the IUD insertion procedure, up to 2 hours

Results posted on

2017-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Active Comparator Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion	Placebo Comparator Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intra Uterine Device Insertion in Nulliparous Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Active Comparator n=1 Participants Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion	Placebo Comparator n=2 Participants Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Gender Female	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Gender Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	1 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants

PRIMARY outcome

Timeframe: During the IUD insertion procedure, up to 2 hours

The primary outcome is the proportion in each group able to have the IUD inserted in a standard fashion without the ancillary measures of mechanical dilation of the cervix, placement of paracervical nerve block, or using abdominal ultrasound for guidance. The null hypothesis for the primary outcome is that misoprostol does not influence difficulty of insertion.

Outcome measures

Outcome measures
Measure	Experimental Active Comparator n=1 Participants Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion	Placebo Comparator n=2 Participants Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
Ease of IUD Insertion (Use of Ancillary Measures)	1 participants	2 participants

Adverse Events

Experimental Active Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Comparator

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

Christina Gavito

University of Colorado Denver

Phone: 303-724-5559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place