Trial Outcomes & Findings for Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion (NCT NCT00635362)
NCT ID: NCT00635362
Last Updated: 2023-03-22
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
12 months after cesarean delivery
Results posted on
2023-03-22
Participant Flow
Location: Two urban academic medical centers from both pre-natal and Labor \& Delivery clinics Dates: May 2007-January 2011 Inclusion: Pregnant, English-speaking women, aged 18 years and older, with planned cesarean delivery, and desiring the LNG-IUS were eligible for the study.
Participant milestones
| Measure |
Delayed Insertion Group
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
|
Postplacental Insertion After Cesarean
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
|
Overall Study
COMPLETED
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion
Baseline characteristics by cohort
| Measure |
Delayed Insertion Group
n=22 Participants
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
|
Postplacental Insertion After Cesarean
n=20 Participants
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
|
Total
n=42 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
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 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
|
28.4 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
27.1 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
27.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 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
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 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
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Marital Status
Single
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Marital Status
Single, living with partner
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Marital Status
Married
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Annual Income
<$10,000
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Annual Income
$10,000-$30,000
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Annual Income
>$30,000
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Insurance Coverage
Medicaid
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Insurance Coverage
Private
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Insurance Coverage
Unknown/Not given
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gestational Age at Delivery
|
38.3 weeks
STANDARD_DEVIATION 1.7 • n=5 Participants
|
38.4 weeks
STANDARD_DEVIATION 1.5 • n=7 Participants
|
38.4 weeks
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Parity at Enrollment
0
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Parity at Enrollment
1
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Parity at Enrollment
2
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Parity at Enrollment
3 or more
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months after cesarean deliveryOutcome measures
| Measure |
Delayed Insertion Group
n=22 Participants
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
|
Postplacental Insertion After Cesarean
n=20 Participants
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
|
|---|---|---|
|
Use of the LNG-IUS for Contraception
Confirmed use of LNG-IUD
|
9 participants
|
12 participants
|
|
Use of the LNG-IUS for Contraception
Lost to follow up at 12 months
|
8 participants
|
6 participants
|
|
Use of the LNG-IUS for Contraception
Did not have IUD placed
|
4 participants
|
0 participants
|
|
Use of the LNG-IUS for Contraception
Expelled prior to 12 months, not replaced
|
0 participants
|
2 participants
|
|
Use of the LNG-IUS for Contraception
Removed per patient request
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 months after cesarean deliveryOutcome measures
| Measure |
Delayed Insertion Group
n=22 Participants
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
|
Postplacental Insertion After Cesarean
n=20 Participants
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
|
|---|---|---|
|
Rates of Expulsion of the LNG-IUS
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 12 months after cesarean deliveryOutcome measures
| Measure |
Delayed Insertion Group
n=22 Participants
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
|
Postplacental Insertion After Cesarean
n=20 Participants
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
|
|---|---|---|
|
Perforation Rates
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 months after cesarean deliveryPopulation: Analysis only done on subject completing six-month visit
We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.
Outcome measures
| Measure |
Delayed Insertion Group
n=11 Participants
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
|
Postplacental Insertion After Cesarean
n=12 Participants
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
|
|---|---|---|
|
Satisfaction With LNG-IUS
|
7 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 12 months after cesarean deliveryPopulation: Analysis only done on subjects completing 12-month visit
We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.
Outcome measures
| Measure |
Delayed Insertion Group
n=9 Participants
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
|
Postplacental Insertion After Cesarean
n=12 Participants
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
|
|---|---|---|
|
Satisfaction With LNG-IUS
|
9 participants
|
11 participants
|
Adverse Events
Delayed Insertion Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Postplacental Insertion After Cesarean
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Delayed Insertion Group
n=22 participants at risk
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
|
Postplacental Insertion After Cesarean
n=20 participants at risk
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
|
|---|---|---|
|
Infections and infestations
Chlamydia
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
|
Reproductive system and breast disorders
Menorrhagia
|
9.1%
2/22 • Number of events 2
|
0.00%
0/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place