Trial Outcomes & Findings for Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device (IUD) After Vaginal Delivery (NCT NCT00476021)
NCT ID: NCT00476021
Last Updated: 2016-06-24
Results Overview
Usage rate of the LNG-IUD at 6 months after delivery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
168 participants
Primary outcome timeframe
6 months after delivery
Results posted on
2016-06-24
Participant Flow
Participant milestones
| Measure |
Postplacental IUD Insertion
Postplacental LNG-IUD insertion
|
Delayed IUD Insertion
Delayed LNG-IUD insertion
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device (IUD) After Vaginal Delivery
Baseline characteristics by cohort
| Measure |
Immediate Postplacental IUD Insertion
n=51 Participants
immediate postplacental IUD insertion
Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years
|
Delayed IUD Insertion (6-8 Weeks After Delivery)
n=51 Participants
delayed IUD insertion (6-8 weeks after delivery)
Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years
|
Total
n=102 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
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 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
|
25.4 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
24.7 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
25.1 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 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
|
51 participants
n=5 Participants
|
51 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Received IUD per protocol
Received IUD per protocol
|
50 participants
n=5 Participants
|
46 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Received IUD per protocol
Did not receive IUD per protocol
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after deliveryPopulation: IUD use at 6 months, lost to follow-up counted as failures
Usage rate of the LNG-IUD at 6 months after delivery
Outcome measures
| Measure |
Postplacental IUD Insertion
n=51 Participants
Postplacental LNG-IUD insertion
|
Delayed IUD Insertion
n=51 Participants
Delayed LNG-IUD insertion
|
|---|---|---|
|
IUD Usage Rate at 6 Months
|
43 participants
|
39 participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Postplacental IUD Insertion
n=51 Participants
Postplacental LNG-IUD insertion
|
Delayed IUD Insertion
Delayed LNG-IUD insertion
|
|---|---|---|
|
Proportion of Women Who Are Able to Have the LNG-IUD Placed Postplacentally and Are Not Excluded From Placement
|
50 participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Postplacental IUD Insertion
n=51 Participants
Postplacental LNG-IUD insertion
|
Delayed IUD Insertion
Delayed LNG-IUD insertion
|
|---|---|---|
|
Follow-up Rates for Delayed Insertion of LNG-IUD
|
46 participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The population only includes women who received IUDs at the specified timepoint. Only 50/51 women in the postplacental group had a successful IUD insertion postplacentally. Only 46 of 51 women in the delayed group returned for a delayed IUD insertion.
Outcome measures
| Measure |
Postplacental IUD Insertion
n=50 Participants
Postplacental LNG-IUD insertion
|
Delayed IUD Insertion
n=46 Participants
Delayed LNG-IUD insertion
|
|---|---|---|
|
Expulsion Rates of Post-placental and Delayed Insertion of the LNG-IUD Using Clinical Exam and Ultrasonography
|
12 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Postplacental IUD Insertion
n=51 Participants
Postplacental LNG-IUD insertion
|
Delayed IUD Insertion
n=51 Participants
Delayed LNG-IUD insertion
|
|---|---|---|
|
Safety of Postplacental Insertion of the LNG-IUD as Measured by Infection Rates
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Postplacental IUD Insertion
n=41 Participants
Postplacental LNG-IUD insertion
|
Delayed IUD Insertion
n=41 Participants
Delayed LNG-IUD insertion
|
|---|---|---|
|
Rates of Follow-up and Unintended Pregnancy Rates for Subjects Who Are Excluded From Postpartum Insertion
|
2 participants
|
11 participants
|
Adverse Events
Postplacental IUD Insertion
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Delayed IUD Insertion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Postplacental IUD Insertion
n=51 participants at risk
Postplacental LNG-IUD insertion
|
Delayed IUD Insertion
n=51 participants at risk
Delayed LNG-IUD insertion
|
|---|---|---|
|
Social circumstances
death
|
2.0%
1/51 • Number of events 1 • 6 months
|
0.00%
0/51 • 6 months
|
Other adverse events
| Measure |
Postplacental IUD Insertion
n=51 participants at risk
Postplacental LNG-IUD insertion
|
Delayed IUD Insertion
n=51 participants at risk
Delayed LNG-IUD insertion
|
|---|---|---|
|
Reproductive system and breast disorders
vaginal laceration
|
2.0%
1/51 • Number of events 1 • 6 months
|
0.00%
0/51 • 6 months
|
|
Reproductive system and breast disorders
retained IUD insertion tube
|
2.0%
1/51 • Number of events 1 • 6 months
|
0.00%
0/51 • 6 months
|
|
Reproductive system and breast disorders
malpositioned IUD
|
2.0%
1/51 • Number of events 1 • 6 months
|
0.00%
0/51 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place