Trial Outcomes & Findings for Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding (NCT NCT01555931)
NCT ID: NCT01555931
Last Updated: 2014-08-25
Results Overview
Reported any breastfeeding at the final 6 month visit
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
6 months
Results posted on
2014-08-25
Participant Flow
26 women failed entry criteria after delivery. Therefore although 61 were enrolled in the original study cohort, only 35 were randomized and allocated to one of the two treatment arms.
Participant milestones
| Measure |
Immediate
Placement within 48 hours of delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery
|
Control
Placement 4-8 weeks after delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Immediate
Placement within 48 hours of delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery
|
Control
Placement 4-8 weeks after delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
Baseline Characteristics
Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding
Baseline characteristics by cohort
| Measure |
Immediate
n=17 Participants
Placement within 48 hours of delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery
|
Control
n=18 Participants
Placement 4-8 weeks after delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 years
n=5 Participants
|
27 years
n=7 Participants
|
27 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latina
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsReported any breastfeeding at the final 6 month visit
Outcome measures
| Measure |
Immediate
n=17 Participants
Placement within 48 hours of delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery
|
Control
n=18 Participants
Placement 4-8 weeks after delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery
|
|---|---|---|
|
Breastfeeding
|
10 participants
|
9 participants
|
SECONDARY outcome
Timeframe: up to 6 monthsExpulsion or indicated removal of the originally placed LNG-IUS at any point during the study
Outcome measures
| Measure |
Immediate
n=17 Participants
Placement within 48 hours of delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery
|
Control
n=18 Participants
Placement 4-8 weeks after delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery
|
|---|---|---|
|
LNG-IUS Expulsion or Removal
|
8 participants
|
0 participants
|
Adverse Events
Immediate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Dr. Gretchen Stuart
University of North Carolina School of Medicine
Phone: 919-962-4880
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place