Trial Outcomes & Findings for Early vs. Interval Postpartum IUD Insertion (NCT NCT03462758)
NCT ID: NCT03462758
Last Updated: 2023-04-13
Results Overview
Complete IUD expulsion will be defined as an IUD which no longer in the uterus on speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
404 participants
Primary outcome timeframe
6 months postpartum
Results posted on
2023-04-13
Participant Flow
Participants were recruited from inpatient postpartum hospital units of the study sites. The first participant was enrolled on March 26, 2018 and the final participant was enrolled on July 29, 2021.
404 patients enrolled in the study, all of whom met inclusion criteria.
Participant milestones
| Measure |
Interval Postpartum IUD Placement
IUD placed 6-8 weeks postpartum (standard of care, interval placement)
IUD: Postpartum IUD placement
|
Early Postpartum IUD Placement
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
IUD: Postpartum IUD placement
|
|---|---|---|
|
Overall Study
STARTED
|
201
|
203
|
|
Overall Study
COMPLETED
|
145
|
149
|
|
Overall Study
NOT COMPLETED
|
56
|
54
|
Reasons for withdrawal
| Measure |
Interval Postpartum IUD Placement
IUD placed 6-8 weeks postpartum (standard of care, interval placement)
IUD: Postpartum IUD placement
|
Early Postpartum IUD Placement
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
IUD: Postpartum IUD placement
|
|---|---|---|
|
Overall Study
Chose no or other method of contraception
|
20
|
23
|
|
Overall Study
Lost to follow-up before IUD placement
|
14
|
12
|
|
Overall Study
Unsuccessful IUD placement attempt
|
3
|
3
|
|
Overall Study
Medical contraindication
|
2
|
2
|
|
Overall Study
Lost to follow-up after IUD placement
|
17
|
14
|
Baseline Characteristics
All participants who had an IUD placed at any time between randomization and 6-month follow-up.
Baseline characteristics by cohort
| Measure |
Interval Postpartum IUD Placement
n=201 Participants
IUD placed 6-8 weeks postpartum (standard of care, interval placement)
IUD: Postpartum IUD placement
|
Early Postpartum IUD Placement
n=203 Participants
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
IUD: Postpartum IUD placement
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 5.5 • n=201 Participants
|
29.8 years
STANDARD_DEVIATION 5.2 • n=203 Participants
|
29.9 years
STANDARD_DEVIATION 5.4 • n=404 Participants
|
|
Sex: Female, Male
Female
|
201 Participants
n=201 Participants
|
203 Participants
n=203 Participants
|
404 Participants
n=404 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=201 Participants
|
0 Participants
n=203 Participants
|
0 Participants
n=404 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
93 Participants
n=201 Participants
|
82 Participants
n=203 Participants
|
175 Participants
n=404 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=201 Participants
|
121 Participants
n=203 Participants
|
229 Participants
n=404 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=201 Participants
|
0 Participants
n=203 Participants
|
0 Participants
n=404 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=201 Participants
|
6 Participants
n=203 Participants
|
9 Participants
n=404 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=201 Participants
|
10 Participants
n=203 Participants
|
22 Participants
n=404 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=201 Participants
|
2 Participants
n=203 Participants
|
2 Participants
n=404 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=201 Participants
|
26 Participants
n=203 Participants
|
46 Participants
n=404 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=201 Participants
|
114 Participants
n=203 Participants
|
228 Participants
n=404 Participants
|
|
Race (NIH/OMB)
More than one race
|
48 Participants
n=201 Participants
|
42 Participants
n=203 Participants
|
90 Participants
n=404 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=201 Participants
|
3 Participants
n=203 Participants
|
7 Participants
n=404 Participants
|
|
Education
High school degree or less
|
122 Participants
n=201 Participants
|
111 Participants
n=203 Participants
|
233 Participants
n=404 Participants
|
|
Education
College degree
|
38 Participants
n=201 Participants
|
43 Participants
n=203 Participants
|
81 Participants
n=404 Participants
|
|
Education
Graduate degree
|
41 Participants
n=201 Participants
|
49 Participants
n=203 Participants
|
90 Participants
n=404 Participants
|
|
Employment
Full time
|
92 Participants
n=201 Participants
|
100 Participants
n=203 Participants
|
192 Participants
n=404 Participants
|
|
Employment
Unemployed/Retired
|
69 Participants
n=201 Participants
|
66 Participants
n=203 Participants
|
135 Participants
n=404 Participants
|
|
Employment
Part time
|
24 Participants
n=201 Participants
|
22 Participants
n=203 Participants
|
46 Participants
n=404 Participants
|
|
Employment
Student
|
16 Participants
n=201 Participants
|
15 Participants
n=203 Participants
|
31 Participants
n=404 Participants
|
|
Type of most recent delivery
Vaginal
|
152 Participants
n=201 Participants
|
155 Participants
n=203 Participants
|
307 Participants
n=404 Participants
|
|
Type of most recent delivery
Cesarean
|
49 Participants
n=201 Participants
|
48 Participants
n=203 Participants
|
97 Participants
n=404 Participants
|
|
Parity
Multiparous
|
130 Participants
n=201 Participants
|
135 Participants
n=203 Participants
|
265 Participants
n=404 Participants
|
|
Parity
Primiparous
|
71 Participants
n=201 Participants
|
68 Participants
n=203 Participants
|
139 Participants
n=404 Participants
|
|
Type of IUD
52-mg levonorgestrel
|
111 Participants
n=162 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
101 Participants
n=163 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
212 Participants
n=325 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
|
Type of IUD
Copper
|
49 Participants
n=162 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
56 Participants
n=163 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
105 Participants
n=325 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
|
Type of IUD
19.5-mg/13.5-mg levonorgestrel
|
2 Participants
n=162 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
6 Participants
n=163 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
8 Participants
n=325 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
|
Ultrasonography used
During placement
|
4 Participants
n=162 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
31 Participants
n=163 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
35 Participants
n=325 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
|
Ultrasonography used
After placement only
|
5 Participants
n=162 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
4 Participants
n=163 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
9 Participants
n=325 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
|
Ultrasonography used
None
|
153 Participants
n=162 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
128 Participants
n=163 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
281 Participants
n=325 Participants • All participants who had an IUD placed at any time between randomization and 6-month follow-up.
|
|
Lactating at time of IUD insertion
Yes
|
127 Participants
n=151 Participants • Excluding missing values on lactation status.
|
139 Participants
n=156 Participants • Excluding missing values on lactation status.
|
266 Participants
n=307 Participants • Excluding missing values on lactation status.
|
|
Lactating at time of IUD insertion
No
|
24 Participants
n=151 Participants • Excluding missing values on lactation status.
|
17 Participants
n=156 Participants • Excluding missing values on lactation status.
|
41 Participants
n=307 Participants • Excluding missing values on lactation status.
|
|
Clinician performing IUD insertion
Faculty physician
|
75 Participants
n=157 Participants • Excluding missing values on clinician type.
|
93 Participants
n=162 Participants • Excluding missing values on clinician type.
|
168 Participants
n=319 Participants • Excluding missing values on clinician type.
|
|
Clinician performing IUD insertion
Advanced practice clinician
|
50 Participants
n=157 Participants • Excluding missing values on clinician type.
|
51 Participants
n=162 Participants • Excluding missing values on clinician type.
|
101 Participants
n=319 Participants • Excluding missing values on clinician type.
|
|
Clinician performing IUD insertion
Resident physician
|
32 Participants
n=157 Participants • Excluding missing values on clinician type.
|
18 Participants
n=162 Participants • Excluding missing values on clinician type.
|
50 Participants
n=319 Participants • Excluding missing values on clinician type.
|
PRIMARY outcome
Timeframe: 6 months postpartumPopulation: Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period.
Complete IUD expulsion will be defined as an IUD which no longer in the uterus on speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use
Outcome measures
| Measure |
Interval Postpartum IUD Placement
n=145 Participants
IUD placed 6-8 weeks postpartum (standard of care, interval placement)
IUD: Postpartum IUD placement
|
Early Postpartum IUD Placement
n=149 Participants
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
IUD: Postpartum IUD placement
|
|---|---|---|
|
Proportion of Participants With an IUD Expulsion (Complete) at 6 Months
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 months postpartumPopulation: Percentages based on total study sample rather than MITT analysis.
IUD utilization will be defined as intrauterine use of an IUD at 6 months postpartum. A speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use
Outcome measures
| Measure |
Interval Postpartum IUD Placement
n=201 Participants
IUD placed 6-8 weeks postpartum (standard of care, interval placement)
IUD: Postpartum IUD placement
|
Early Postpartum IUD Placement
n=203 Participants
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
IUD: Postpartum IUD placement
|
|---|---|---|
|
Proportion of Participants Using an IUD at 6 Months
|
139 Participants
|
141 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period.
Partial IUD expulsions will be diagnosed in any participant found to have an IUD in which part of the body of the IUD is noted to be coming through the external cervical os on speculum exam.
Outcome measures
| Measure |
Interval Postpartum IUD Placement
n=145 Participants
IUD placed 6-8 weeks postpartum (standard of care, interval placement)
IUD: Postpartum IUD placement
|
Early Postpartum IUD Placement
n=149 Participants
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
IUD: Postpartum IUD placement
|
|---|---|---|
|
Proportion of Participants With an IUD Expulsion (Partial) at 6 Months
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period.
Pelvic infection requiring antibiotics will be ascertained by patient report and/or medical record review.
Outcome measures
| Measure |
Interval Postpartum IUD Placement
n=145 Participants
IUD placed 6-8 weeks postpartum (standard of care, interval placement)
IUD: Postpartum IUD placement
|
Early Postpartum IUD Placement
n=149 Participants
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
IUD: Postpartum IUD placement
|
|---|---|---|
|
Proportion of Participants With a Pelvic Infection Within 6 Months
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period.
Participants are asked how much they agree with the statement "I am satisfied with using this IUD." Answers are valued 1-5, with 1 Strongly Agree, 2 Agree, 3 Neutral, 4 Disagree, and 5 Strongly Disagree. 1=Strongly Agree is considered the best outcome, 5=Strongly disagree is considered the worst outcome. Outcome reported is those who were very satisfied or satisfied.
Outcome measures
| Measure |
Interval Postpartum IUD Placement
n=145 Participants
IUD placed 6-8 weeks postpartum (standard of care, interval placement)
IUD: Postpartum IUD placement
|
Early Postpartum IUD Placement
n=149 Participants
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
IUD: Postpartum IUD placement
|
|---|---|---|
|
Patient Satisfaction With IUD Assessed on a Five-point "Likert" Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement
|
116 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period.
IUD perforations through the uterus will be diagnosed when an IUD visible is not visible on transvaginal ultrasound of the uterus but is visible on x-ray of the abdomen or pelvis.
Outcome measures
| Measure |
Interval Postpartum IUD Placement
n=145 Participants
IUD placed 6-8 weeks postpartum (standard of care, interval placement)
IUD: Postpartum IUD placement
|
Early Postpartum IUD Placement
n=149 Participants
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
IUD: Postpartum IUD placement
|
|---|---|---|
|
Proportion of Participants With an IUD Perforation at 6 Months
|
0 Participants
|
0 Participants
|
Adverse Events
Interval Postpartum IUD Placement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Early Postpartum 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
Adverse event data not reported
Additional Information
Dr. Sarah Averbach, MD, MAS
University of California, San Diego
Phone: 858-329-4464
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place