Trial Outcomes & Findings for LNG-IUS at 2 Weeks Postpartum (NCT NCT02121067)

Results Overview

A dichotomous, yes/no answer to the following question "Would you recommend Mirena placement at two-weeks postpartum to a friend?"

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

6 months postpartum

Results posted on

2017-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	LNG-IUS Placed at 2 Weeks Postpartum Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LNG-IUS at 2 Weeks Postpartum

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LNG-IUS Placed at 2 Weeks Postpartum n=50 Participants Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	30 years n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months postpartum

Population: Of the 50 participants who enrolled, only 43 were available at 6 months postpartum to provide data for the first primary outcome.

A dichotomous, yes/no answer to the following question "Would you recommend Mirena placement at two-weeks postpartum to a friend?"

Outcome measures

Outcome measures
Measure	LNG-IUS Placed at 2 Weeks Postpartum n=43 Participants Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled
Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.	40 Participants

PRIMARY outcome

Timeframe: Day 14-20 postpartum

Was the LNG-IUS successfully placed in the study period, as determined by whether the participant had an LNG-IUS placed on the day of insertion?

Outcome measures

Outcome measures
Measure	LNG-IUS Placed at 2 Weeks Postpartum n=50 Participants Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled
Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.	50 Participants

SECONDARY outcome

Timeframe: 6 months postpartum

Population: Of the 50 participants who enrolled and had an LNG-IUS placed at 2 weeks postpartum, only 43 were available at 6 months postpartum to provide data for expulsion.

Expulsion will be defined as any of the following (1) patient report that the LNG-IUS came out, (2) ultrasound evaluation that demonstrates the LNG-IUS is not intrauterine (3) ultrasound or clinical evaluation that demonstrates the majority of the LNG-IUS is located in the cervix.

Outcome measures

Outcome measures
Measure	LNG-IUS Placed at 2 Weeks Postpartum n=43 Participants Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled
Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.	2 Participants

Adverse Events

LNG-IUS Placed at 2 Weeks Postpartum

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

Matthew Zerden, MD, MPH

University of North Carolina

Phone: 6179352394

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place