Trial Outcomes & Findings for Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study (NCT NCT02067663)
NCT ID: NCT02067663
Last Updated: 2019-07-05
Results Overview
The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.
Recruitment status
COMPLETED
Target enrollment
123 participants
Primary outcome timeframe
3 months postpartum
Results posted on
2019-07-05
Participant Flow
This prospective cohort trial was conducted at 2 affiliated teaching hospitals: University of Colorado Hospital (UCH) in Aurora, CO, and Denver Health Medical Center (DHMC) in Denver, CO.
Participant milestones
| Measure |
Mirena Group
Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Mirena: The IUD will be placed as part of standard clinical care.
|
Paragard Group
Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Paragard: The IUD will be placed as part of standard clinical care.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
55
|
|
Overall Study
COMPLETED
|
55
|
41
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
Reasons for withdrawal
| Measure |
Mirena Group
Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Mirena: The IUD will be placed as part of standard clinical care.
|
Paragard Group
Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Paragard: The IUD will be placed as part of standard clinical care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
14
|
Baseline Characteristics
Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study
Baseline characteristics by cohort
| Measure |
Mirena Group
n=68 Participants
Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Mirena: The IUD will be placed as part of standard clinical care.
|
Paragard Group
n=55 Participants
Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Paragard: The IUD will be placed as part of standard clinical care.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.2 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
27.4 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
26.72 years
STANDARD_DEVIATION 5.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
55 participants
n=7 Participants
|
123 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months postpartumThe primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.
Outcome measures
| Measure |
Mirena Group
n=55 Participants
Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Mirena: The IUD will be placed as part of standard clinical care.
|
Paragard Group
n=41 Participants
Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Paragard: The IUD will be placed as part of standard clinical care.
|
|---|---|---|
|
IUD Expulsion Rate
|
20 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 weeksA urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated.
Outcome measures
| Measure |
Mirena Group
n=56 Participants
Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Mirena: The IUD will be placed as part of standard clinical care.
|
Paragard Group
n=45 Participants
Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Paragard: The IUD will be placed as part of standard clinical care.
|
|---|---|---|
|
Pregnancy
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsA urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated.
Outcome measures
| Measure |
Mirena Group
n=56 Participants
Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Mirena: The IUD will be placed as part of standard clinical care.
|
Paragard Group
n=45 Participants
Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Paragard: The IUD will be placed as part of standard clinical care.
|
|---|---|---|
|
Pregnancy
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsA questionnaire will be administered to determine if the participant has had any complications since placement. Number of women reporting complications are reported.
Outcome measures
| Measure |
Mirena Group
n=55 Participants
Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Mirena: The IUD will be placed as part of standard clinical care.
|
Paragard Group
n=41 Participants
Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Paragard: The IUD will be placed as part of standard clinical care.
|
|---|---|---|
|
Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsA questionnaire will be administered to determine the participant's satisfaction level with the IUD. Satisfaction levels of \>= 8 are reported by percent of participants.
Outcome measures
| Measure |
Mirena Group
n=35 Participants
Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Mirena: The IUD will be placed as part of standard clinical care.
|
Paragard Group
n=34 Participants
Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Paragard: The IUD will be placed as part of standard clinical care.
|
|---|---|---|
|
Satisfaction
|
91.4 percent of participants
|
94.2 percent of participants
|
SECONDARY outcome
Timeframe: Day 1Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound.
Outcome measures
| Measure |
Mirena Group
n=56 Participants
Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Mirena: The IUD will be placed as part of standard clinical care.
|
Paragard Group
n=45 Participants
Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Paragard: The IUD will be placed as part of standard clinical care.
|
|---|---|---|
|
Intrauterine Device Expulsion (Day 1)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 weeksNumber of expulsions. Position of the IUD within the uterus will be documented by ultrasound.
Outcome measures
| Measure |
Mirena Group
n=56 Participants
Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Mirena: The IUD will be placed as part of standard clinical care.
|
Paragard Group
n=45 Participants
Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Paragard: The IUD will be placed as part of standard clinical care.
|
|---|---|---|
|
Intrauterine Device Expulsion (6 Weeks)
|
18 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 12 weeksPosition of the IUD within the uterus will be documented by ultrasound.
Outcome measures
| Measure |
Mirena Group
n=55 Participants
Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Mirena: The IUD will be placed as part of standard clinical care.
|
Paragard Group
n=41 Participants
Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Paragard: The IUD will be placed as part of standard clinical care.
|
|---|---|---|
|
Intrauterine Device Expulsion by 12 Weeks Postpartum
|
21 Participants
|
8 Participants
|
Adverse Events
Mirena Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Paragard Group
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
Lisa Goldthwaite
Stanford University School of Medicine
Phone: 541-515-1825
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place