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Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding (PPIUD1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01555931
Recruitment Status : Completed
First Posted : March 16, 2012
Results First Posted : August 25, 2014
Last Update Posted : August 25, 2014
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Postpartum Contraception
Intervention Drug: Levonorgestrel-releasing intrauterine system
Enrollment 61
Recruitment Details  
Pre-assignment Details 26 women failed entry criteria after delivery. Therefore although 61 were enrolled in the original study cohort, only 35 were randomized and allocated to one of the two treatment arms.
Arm/Group Title Immediate Control
Hide Arm/Group Description

Placement within 48 hours of delivery

Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery

Placement 4-8 weeks after delivery

Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery

Period Title: Overall Study
Started 17 18
Completed 15 13
Not Completed 2 5
Reason Not Completed
Lost to Follow-up             2             5
Arm/Group Title Immediate Control Total
Hide Arm/Group Description

Placement within 48 hours of delivery

Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery

Placement 4-8 weeks after delivery

Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery

Total of all reporting groups
Overall Number of Baseline Participants 17 18 35
Hide Baseline Analysis Population Description
Baseline characteristics of women allocated to immediate or late LNG-IUS placement after delivery.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 17 participants 18 participants 35 participants
28
(25 to 30)
27
(25 to 29)
27
(25 to 29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 18 participants 35 participants
Female
17
 100.0%
18
 100.0%
35
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 17 participants 18 participants 35 participants
White, non-Hispanic 8 10 18
Black, non-Hispanic 5 2 7
Hispanic or Latina 3 5 8
Other 1 1 2
1.Primary Outcome
Title Breastfeeding
Hide Description Reported any breastfeeding at the final 6 month visit
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Control
Hide Arm/Group Description:

Placement within 48 hours of delivery

Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery

Placement 4-8 weeks after delivery

Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery

Overall Number of Participants Analyzed 17 18
Measure Type: Number
Unit of Measure: participants
10 9
2.Secondary Outcome
Title LNG-IUS Expulsion or Removal
Hide Description Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Control
Hide Arm/Group Description:

Placement within 48 hours of delivery

Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery

Placement 4-8 weeks after delivery

Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery

Overall Number of Participants Analyzed 17 18
Measure Type: Number
Unit of Measure: participants
8 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immediate Control
Hide Arm/Group Description

Placement within 48 hours of delivery

Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery

Placement 4-8 weeks after delivery

Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery

All-Cause Mortality
Immediate Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Immediate Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immediate Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/18 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Gretchen Stuart
Organization: University of North Carolina School of Medicine
Phone: 919-962-4880
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01555931     History of Changes
Other Study ID Numbers: 11-1786
First Submitted: March 14, 2012
First Posted: March 16, 2012
Results First Submitted: July 14, 2014
Results First Posted: August 25, 2014
Last Update Posted: August 25, 2014