Trial Outcomes & Findings for BLIS - Breastfeeding Levonorgestrel IUD Study (NCT NCT01990703)

Results Overview

To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

285 participants

Primary outcome timeframe

8 weeks postpartum

Results posted on

2017-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Early IUD Insertion Group Immediate post-placental placement of the levonorgestrel IUD Levonorgestrel IUD: Timing of IUD insertion	Standard Postpartum Insertion Group Placement of the levonorgestrel IUD 4-6 weeks postpartum Levonorgestrel IUD: Timing of IUD insertion
Overall Study STARTED	147	138
Overall Study COMPLETED	108	93
Overall Study NOT COMPLETED	39	45

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BLIS - Breastfeeding Levonorgestrel IUD Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early IUD Insertion Group n=147 Participants Immediate post-placental placement of the levonorgestrel IUD Levonorgestrel IUD: Timing of IUD insertion	Standard Postpartum Insertion Group n=138 Participants Placement of the levonorgestrel IUD 4-6 weeks postpartum Levonorgestrel IUD: Timing of IUD insertion	Total n=285 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	147 Participants n=5 Participants	138 Participants n=7 Participants	285 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.6 Years STANDARD_DEVIATION 5.4 • n=5 Participants	28.1 Years STANDARD_DEVIATION 5.6 • n=7 Participants	28.4 Years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	147 Participants n=5 Participants	138 Participants n=7 Participants	285 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	147 participants n=5 Participants	138 participants n=7 Participants	285 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks postpartum

Population: 147 Early IUD Insertion participants at baseline drops to 112 at 8 weeks due to exclusions for medical complications (n=15), inability to provide immediate IUD (n=7) and loss to follow up (n=13). In the Standard Insertion group 138 at baseline drops to 102 at 8 weeks with medical comps (n=11), failure to receive IUD (n=24), and 1 loss to follow up.

To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.

Outcome measures

Outcome measures
Measure	Early IUD Insertion Group n=112 Participants Immediate post-placental placement of the levonorgestrel IUD Levonorgestrel IUD: Timing of IUD insertion	Standard Postpartum Insertion Group n=102 Participants Placement of the levonorgestrel IUD 4-6 weeks postpartum Levonorgestrel IUD: Timing of IUD insertion
Breastfeeding Continuation Rates at 8 Weeks Postpartum	88 Participants	86 Participants

SECONDARY outcome

Timeframe: First 5 days after birth

To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.

Outcome measures

Outcome measures
Measure	Early IUD Insertion Group n=125 Participants Immediate post-placental placement of the levonorgestrel IUD Levonorgestrel IUD: Timing of IUD insertion	Standard Postpartum Insertion Group n=103 Participants Placement of the levonorgestrel IUD 4-6 weeks postpartum Levonorgestrel IUD: Timing of IUD insertion
Time to Lactogenesis Stage 2	65.3 Hours Standard Deviation 25.7	63.6 Hours Standard Deviation 21.6

Adverse Events

Early IUD Insertion Group

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard Postpartum Insertion Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Early IUD Insertion Group n=147 participants at risk Immediate post-placental placement of the levonorgestrel IUD Levonorgestrel IUD: Timing of IUD insertion	Standard Postpartum Insertion Group n=138 participants at risk Placement of the levonorgestrel IUD 4-6 weeks postpartum Levonorgestrel IUD: Timing of IUD insertion
Psychiatric disorders Suicidal behavior	0.68% 1/147 • Number of events 1	0.00% 0/138

Other adverse events

Other adverse events
Measure	Early IUD Insertion Group n=147 participants at risk Immediate post-placental placement of the levonorgestrel IUD Levonorgestrel IUD: Timing of IUD insertion	Standard Postpartum Insertion Group n=138 participants at risk Placement of the levonorgestrel IUD 4-6 weeks postpartum Levonorgestrel IUD: Timing of IUD insertion
Gastrointestinal disorders Cholangitis	0.68% 1/147 • Number of events 1	0.00% 0/138

Additional Information

Dr. David Turok

University of Utah, Department of OBGYN

Phone: 801-581-6170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place