Trial Outcomes & Findings for Early Postpartum Intrauterine Device (IUD) Placement (NCT NCT01594476)
NCT ID: NCT01594476
Last Updated: 2019-01-11
Results Overview
Subjects will be contacted by phone or email at 3 months after delivery. We will compare the proportion of subjects who report having an IUD in place at 3 months after delivery of those who are randomized to each group (placement at either 3 weeks or 6 weeks) .
TERMINATED
PHASE4
201 participants
Three months after delivery
2019-01-11
Participant Flow
Participant milestones
| Measure |
IUD Insertion at 3 Weeks
IUD placement at 3 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS or Copper T intrauterine device
|
IUD Insertion at 6 Weeks
IUD placement at 6 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS or Copper T intrauterine device
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
100
|
|
Overall Study
Received Intervention
|
66
|
73
|
|
Overall Study
Excluded After Allocation
|
1
|
3
|
|
Overall Study
IUD Removal
|
3
|
5
|
|
Overall Study
IUD Expulsion
|
2
|
0
|
|
Overall Study
Pregnant
|
2
|
5
|
|
Overall Study
COMPLETED
|
100
|
97
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
IUD Insertion at 3 Weeks
IUD placement at 3 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS or Copper T intrauterine device
|
IUD Insertion at 6 Weeks
IUD placement at 6 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS or Copper T intrauterine device
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
3
|
Baseline Characteristics
Early Postpartum Intrauterine Device (IUD) Placement
Baseline characteristics by cohort
| Measure |
Levonorgestrel IUS Insertion at 3 Weeks
n=100 Participants
IUD placement at 3 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
Levonorgestrel IUS Insertion at 6 Weeks
n=97 Participants
IUD placement at 6 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
29.0 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
28.6 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
197 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
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
86 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
170 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
|
|
Insurance type
Public insurance
|
48 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Insurance type
Private insurance
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Planned pregnancy
Unplanned
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Planned pregnancy
Planned
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Delivery type
Vaginal
|
75 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Delivery type
Cesarean
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Education
High school/GED or less
|
31 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Education
More than high school
|
69 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Snyder Hope Scale
Future Scale total score
|
47.2 units on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
45.9 units on a scale
STANDARD_DEVIATION 6.7 • n=7 Participants
|
46.5 units on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Snyder Hope Scale
Agency subscale score
|
23.8 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
22.9 units on a scale
STANDARD_DEVIATION 4.1 • n=7 Participants
|
23.4 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Snyder Hope Scale
Pathway subscale score
|
23.4 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
22.8 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
23.1 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Social-Support Scale
MDSS total score
|
65.8 units on a scale
STANDARD_DEVIATION 9.0 • n=5 Participants
|
63.5 units on a scale
STANDARD_DEVIATION 10.7 • n=7 Participants
|
64.7 units on a scale
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Social-Support Scale
Family subscale score
|
22.0 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
20.4 units on a scale
STANDARD_DEVIATION 5.6 • n=7 Participants
|
21.2 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Social-Support Scale
Friends subscale score
|
21.3 units on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
20.5 units on a scale
STANDARD_DEVIATION 5.2 • n=7 Participants
|
20.9 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Social-Support Scale
Significant other subscale score
|
23.0 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
22.4 units on a scale
STANDARD_DEVIATION 3.2 • n=7 Participants
|
22.7 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Three months after deliveryPopulation: Data analyzed as intent to treat regardless of when they had their IUD placed. This is IUD placed by 3 months in each group.
Subjects will be contacted by phone or email at 3 months after delivery. We will compare the proportion of subjects who report having an IUD in place at 3 months after delivery of those who are randomized to each group (placement at either 3 weeks or 6 weeks) .
Outcome measures
| Measure |
IUD Insertion at 3 Weeks
n=100 Participants
IUD placement at 3 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
IUD Insertion at 6 Weeks
n=97 Participants
IUD placement at 6 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
18-24 Days After Cesarean Delivery
IUD placement at 18-24 days after cesarean delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
39-45 Days After Cesarean Delivery
IUD placement at 39-45 days after cesarean delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
|---|---|---|---|---|
|
Subjects With an IUD at 3 Months Postpartum
|
66 Participants
|
73 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately following IUD placement.Population: Includes all subjects enrolled on protocol who underwent IUD placement at a study visit at any timing prior to 3 months postpartum. Comparison is based on randomization timing but actual timing of placement may have differed. Numbers differ from primary outcome due to removals and expulsion prior to 3 months, and placement outside study visits.
Subjects were asked to record their overall satisfaction with the timing of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating "very dissatisfied" and "very satisfied." The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher satisfaction.
Outcome measures
| Measure |
IUD Insertion at 3 Weeks
n=68 Participants
IUD placement at 3 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
IUD Insertion at 6 Weeks
n=68 Participants
IUD placement at 6 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
18-24 Days After Cesarean Delivery
IUD placement at 18-24 days after cesarean delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
39-45 Days After Cesarean Delivery
IUD placement at 39-45 days after cesarean delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
|---|---|---|---|---|
|
Satisfaction With the Timing of IUD Placement.
|
90.6 mm on VAS
Standard Deviation 17.2
|
93.5 mm on VAS
Standard Deviation 12.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At IUD placementPopulation: Subjects who had their IUD placed at the allocated timing of 18-24 days versus 39-45 days
Transvaginal ultrasound will be performed immediately following IUD placement. The thickness of the uterine myometrium at the fundus from the endometrium to the outer edge of the serosa will be measured in centimeters using an ultrasound caliper in the sagittal view.
Outcome measures
| Measure |
IUD Insertion at 3 Weeks
n=54 Participants
IUD placement at 3 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
IUD Insertion at 6 Weeks
n=61 Participants
IUD placement at 6 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
18-24 Days After Cesarean Delivery
IUD placement at 18-24 days after cesarean delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
39-45 Days After Cesarean Delivery
IUD placement at 39-45 days after cesarean delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
|---|---|---|---|---|
|
Uterine Thickness at the Fundus
|
2.3 cm
Standard Deviation 0.8
|
1.7 cm
Standard Deviation 0.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Six months after deliveryPopulation: Population is subject randomization groups.
Subjects will return to clinic for an ultrasound and exam at six months after delivery. We will compare the proportion of subjects with an IUD at this time of those randomized to each placement timing.
Outcome measures
| Measure |
IUD Insertion at 3 Weeks
n=100 Participants
IUD placement at 3 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
IUD Insertion at 6 Weeks
n=97 Participants
IUD placement at 6 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
18-24 Days After Cesarean Delivery
IUD placement at 18-24 days after cesarean delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
39-45 Days After Cesarean Delivery
IUD placement at 39-45 days after cesarean delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
|---|---|---|---|---|
|
Subjects With an IUD at 6 Months Postpartum
|
53 Participants
|
53 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Six months after deliveryPopulation: All subjects analyzed. This includes all subjects enrolled on protocol and allocated. There were no adverse events in the subjects excluded after allocation.
Subjects will be followed for 6 months each. Over the 6 month study period, the number and proportion of subjects who experience adverse events including treatment for infection, IUD expulsion or IUD perforation will be assessed.
Outcome measures
| Measure |
IUD Insertion at 3 Weeks
n=100 Participants
IUD placement at 3 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
IUD Insertion at 6 Weeks
n=97 Participants
IUD placement at 6 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
18-24 Days After Cesarean Delivery
IUD placement at 18-24 days after cesarean delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
39-45 Days After Cesarean Delivery
IUD placement at 39-45 days after cesarean delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
|---|---|---|---|---|
|
Number of Subjects With Adverse Events
IUD expulsion
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Adverse Events
IUD perforation
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Adverse Events
Pregnancy with IUD in place
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Adverse Events
Infection with IUD in place
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Adverse Events
No known adverse events
|
98 Participants
|
97 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the time of IUD placement.Population: Subjects analyzed by actual timing of IUD insertion
Subjects were asked to record their current pain immediate at the time of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating "no pain" and "worst pain in my life." The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher pain. The distance from the left side of the 10 cm line to the mark will be measured in millimeters and compared between randomization groups if they received an IUD at the allocated timing of 18-24 or 39-45 days.
Outcome measures
| Measure |
IUD Insertion at 3 Weeks
n=39 Participants
IUD placement at 3 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
IUD Insertion at 6 Weeks
n=47 Participants
IUD placement at 6 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
18-24 Days After Cesarean Delivery
n=16 Participants
IUD placement at 18-24 days after cesarean delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
39-45 Days After Cesarean Delivery
n=14 Participants
IUD placement at 39-45 days after cesarean delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
|---|---|---|---|---|
|
Pain With IUD Placement
|
15.7 mm
Standard Deviation 16.4
|
23.0 mm
Standard Deviation 21.0
|
30.9 mm
Standard Deviation 27.3
|
32.1 mm
Standard Deviation 27.9
|
Adverse Events
IUD Insertion at 3 Weeks
IUD Insertion at 6 Weeks
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IUD Insertion at 3 Weeks
n=100 participants at risk
IUD placement at 3 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
IUD Insertion at 6 Weeks
n=97 participants at risk
IUD placement at 6 weeks after delivery.
Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
|
|---|---|---|
|
Reproductive system and breast disorders
IUD expulsion
|
2.0%
2/100 • Number of events 2
|
0.00%
0/97
|
Additional Information
Dr. Maureen Baldwin, MD MPH
Oregon Health & Science University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place