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Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion

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ClinicalTrials.gov Identifier: NCT00635362
Recruitment Status : Terminated (Low recruitment)
First Posted : March 13, 2008
Results First Posted : May 13, 2013
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
Melissa Gilliam, University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Healthy
Intervention Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Enrollment 42
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Delayed Insertion Group Postplacental Insertion After Cesarean
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 22 20
Completed 9 12
Not Completed 13 8
Arm/Group Title Delayed Insertion Group Postplacental Insertion After Cesarean Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 22 20 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
20
 100.0%
42
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 20 participants 42 participants
28.4  (5.3) 27.1  (6.2) 27.8  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 42 participants
Female
22
 100.0%
20
 100.0%
42
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 42 participants
Hispanic or Latino
3
  13.6%
0
   0.0%
3
   7.1%
Not Hispanic or Latino
19
  86.4%
20
 100.0%
39
  92.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 42 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  68.2%
14
  70.0%
29
  69.0%
White
4
  18.2%
4
  20.0%
8
  19.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  13.6%
2
  10.0%
5
  11.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 20 participants 42 participants
22 20 42
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 42 participants
Single 12 10 22
Single, living with partner 1 2 3
Married 9 8 17
Annual Income  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 42 participants
<$10,000 7 6 13
$10,000-$30,000 6 7 13
>$30,000 9 7 16
Insurance Coverage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 42 participants
Medicaid 16 14 30
Private 5 6 11
Unknown/Not given 1 0 1
Gestational Age at Delivery  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 22 participants 20 participants 42 participants
38.3  (1.7) 38.4  (1.5) 38.4  (1.6)
Parity at Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 42 participants
0 1 1 2
1 10 7 17
2 8 9 17
3 or more 3 3 6
1.Primary Outcome
Title Use of the LNG-IUS for Contraception
Hide Description [Not Specified]
Time Frame 12 months after cesarean delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Delayed Insertion Group Postplacental Insertion After Cesarean
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 22 20
Measure Type: Number
Unit of Measure: participants
Confirmed use of LNG-IUD 9 12
Lost to follow up at 12 months 8 6
Did not have IUD placed 4 0
Expelled prior to 12 months, not replaced 0 2
Removed per patient request 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Delayed Insertion Group, Postplacental Insertion After Cesarean
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Rates of Expulsion of the LNG-IUS
Hide Description [Not Specified]
Time Frame 12 months after cesarean delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Delayed Insertion Group Postplacental Insertion After Cesarean
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 22 20
Measure Type: Number
Unit of Measure: participants
0 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Delayed Insertion Group, Postplacental Insertion After Cesarean
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Perforation Rates
Hide Description [Not Specified]
Time Frame 12 months after cesarean delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Delayed Insertion Group Postplacental Insertion After Cesarean
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 22 20
Measure Type: Number
Unit of Measure: participants
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Delayed Insertion Group, Postplacental Insertion After Cesarean
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Satisfaction With LNG-IUS
Hide Description 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.
Time Frame 6 months after cesarean delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis only done on subject completing six-month visit
Arm/Group Title Delayed Insertion Group Postplacental Insertion After Cesarean
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 12
Measure Type: Number
Unit of Measure: participants
7 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Delayed Insertion Group, Postplacental Insertion After Cesarean
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Satisfaction With LNG-IUS
Hide Description 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.
Time Frame 12 months after cesarean delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis only done on subjects completing 12-month visit
Arm/Group Title Delayed Insertion Group Postplacental Insertion After Cesarean
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 9 12
Measure Type: Number
Unit of Measure: participants
9 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Delayed Insertion Group, Postplacental Insertion After Cesarean
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Delayed Insertion Group Postplacental Insertion After Cesarean
Hide Arm/Group Description

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

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

All-Cause Mortality
Delayed Insertion Group Postplacental Insertion After Cesarean
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Delayed Insertion Group Postplacental Insertion After Cesarean
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Delayed Insertion Group Postplacental Insertion After Cesarean
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/22 (9.09%)      1/20 (5.00%)    
Infections and infestations     
Chlamydia  1  0/22 (0.00%)  0 1/20 (5.00%)  1
Reproductive system and breast disorders     
Menorrhagia  2  2/22 (9.09%)  2 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
2
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Amy Whitaker, MD
Organization: University of Chicago
Phone: 773-834-4129
Responsible Party: Melissa Gilliam, University of Chicago
ClinicalTrials.gov Identifier: NCT00635362     History of Changes
Other Study ID Numbers: 15148A
First Submitted: March 5, 2008
First Posted: March 13, 2008
Results First Submitted: February 22, 2013
Results First Posted: May 13, 2013
Last Update Posted: May 13, 2013