Trial Outcomes & Findings for Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial (NCT NCT01539759)
NCT ID: NCT01539759
Last Updated: 2017-10-13
Results Overview
The use of an IUD at 6 months postpartum is the primary outcome measure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
6 months postpartum
Results posted on
2017-10-13
Participant Flow
Participant milestones
| Measure |
Interval IUD Placement
Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
|
Immediate Postplacental IUD Placement
Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
|
Overall Study
Had Successful IUD Placement
|
34
|
53
|
|
Overall Study
IUD Expulsion
|
1
|
4
|
|
Overall Study
IUD Removal
|
2
|
7
|
|
Overall Study
IUD in Place at 6 Months Posptartum
|
32
|
40
|
|
Overall Study
COMPLETED
|
50
|
48
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
Interval IUD Placement
Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
|
Immediate Postplacental IUD Placement
Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
8
|
Baseline Characteristics
Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial
Baseline characteristics by cohort
| Measure |
Interval IUD Placement
n=56 Participants
Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
|
Immediate Postplacental IUD Placement
n=56 Participants
Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION .51 • n=5 Participants
|
28 years
STANDARD_DEVIATION .57 • n=7 Participants
|
28 years
STANDARD_DEVIATION .51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
112 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
|
22 participants
n=5 Participants
|
26 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
18 participants
n=5 Participants
|
13 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months postpartumThe use of an IUD at 6 months postpartum is the primary outcome measure
Outcome measures
| Measure |
Interval IUD Placement
n=50 Participants
Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
|
Immediate Postplacental IUD Placement
n=48 Participants
Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta
|
|---|---|---|
|
IUD Use
|
32 participants
|
40 participants
|
SECONDARY outcome
Timeframe: 0-6 months postpartumOutcome measures
| Measure |
Interval IUD Placement
n=50 Participants
Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
|
Immediate Postplacental IUD Placement
n=48 Participants
Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta
|
|---|---|---|
|
IUD Expulsion
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 0-6 months postpartumOutcome measures
| Measure |
Interval IUD Placement
n=39 Participants
Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
|
Immediate Postplacental IUD Placement
n=30 Participants
Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta
|
|---|---|---|
|
Women's Satisfaction With IUDs
|
92 percentage of participants satisfied
|
100 percentage of participants satisfied
|
Adverse Events
Interval IUD Placement
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Immediate Postplacental IUD Placement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Interval IUD Placement
n=56 participants at risk
Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
|
Immediate Postplacental IUD Placement
n=56 participants at risk
Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta
|
|---|---|---|
|
Reproductive system and breast disorders
Uterine Perforation
|
1.8%
1/56 • Number of events 1
|
0.00%
0/56
|
Additional Information
Erika Levi, MD and Gretchen Stuart, MD
University of North Carolina
Phone: (919) 843-5633
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place