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Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device (IUD) After Vaginal Delivery (POPI)

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ClinicalTrials.gov Identifier: NCT00476021
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : February 19, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Beatrice Chen, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Contraception
Intervention Device: Levonorgestrel-releasing IUD (Mirena)
Enrollment 168
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Postplacental IUD Insertion Delayed IUD Insertion
Hide Arm/Group Description Postplacental LNG-IUD insertion Delayed LNG-IUD insertion
Period Title: Overall Study
Started 51 51
Completed 51 51
Not Completed 0 0
Arm/Group Title Immediate Postplacental IUD Insertion Delayed IUD Insertion (6-8 Weeks After Delivery) Total
Hide Arm/Group Description

immediate postplacental IUD insertion

Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years

delayed IUD insertion (6-8 weeks after delivery)

Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years

Total of all reporting groups
Overall Number of Baseline Participants 51 51 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
 100.0%
51
 100.0%
102
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 51 participants 102 participants
25.4  (5.3) 24.7  (5.2) 25.1  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
Female
51
 100.0%
51
 100.0%
102
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants 51 participants 102 participants
51 51 102
Received IUD per protocol  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
Received IUD per protocol 50 46 96
Did not receive IUD per protocol 1 5 6
1.Primary Outcome
Title IUD Usage Rate at 6 Months
Hide Description Usage rate of the LNG-IUD at 6 months after delivery
Time Frame 6 months after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
IUD use at 6 months, lost to follow-up counted as failures
Arm/Group Title Postplacental IUD Insertion Delayed IUD Insertion
Hide Arm/Group Description:
Postplacental LNG-IUD insertion
Delayed LNG-IUD insertion
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: participants
43 39
2.Secondary Outcome
Title Proportion of Women Who Are Able to Have the LNG-IUD Placed Postplacentally and Are Not Excluded From Placement
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Received Postplacental IUD
Hide Arm/Group Description:
Received postplacental LNG-IUD
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: participants
50
3.Secondary Outcome
Title Follow-up Rates for Delayed Insertion of LNG-IUD
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Delayed IUD Insertion
Hide Arm/Group Description:
Followed up for delayed IUD insertion
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: participants
46
4.Secondary Outcome
Title Expulsion Rates of Post-placental and Delayed Insertion of the LNG-IUD Using Clinical Exam and Ultrasonography
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The population only includes women who received IUDs at the specified timepoint. Only 50/51 women in the postplacental group had a successful IUD insertion postplacentally. Only 46 of 51 women in the delayed group returned for a delayed IUD insertion.
Arm/Group Title Postplacental IUD Insertion Delayed IUD Insertion
Hide Arm/Group Description:
Postplacental LNG-IUD insertion
Delayed LNG-IUD insertion
Overall Number of Participants Analyzed 50 46
Measure Type: Number
Unit of Measure: participants
12 2
5.Secondary Outcome
Title Safety of Postplacental Insertion of the LNG-IUD as Measured by Infection Rates
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Postplacental IUD Insertion Delayed IUD Insertion
Hide Arm/Group Description:
Infection after postplacental LNG-IUD insertion
Infection after delayed LNG-IUD insertion
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: participants
1 1
6.Secondary Outcome
Title Rates of Follow-up and Unintended Pregnancy Rates for Subjects Who Are Excluded From Postpartum Insertion
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregnancy Within 6 Months for Ineligible Participants Follow-up for IUD Insertion for Ineligible Participants
Hide Arm/Group Description:
If a participant was found to be ineligible as a result of postenrollment criteria, she was instructed to follow up with her primary obstetrician or midwife for postpartum contraception and delayed IUD insertion
Ineligible participants were followed for 6 months to evaluate whether they received an IUD from their ob/gyn
Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
2 11
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Postplacental IUD Insertion Delayed IUD Insertion
Hide Arm/Group Description Postplacental LNG-IUD insertion Delayed LNG-IUD insertion
All-Cause Mortality
Postplacental IUD Insertion Delayed IUD Insertion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Postplacental IUD Insertion Delayed IUD Insertion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/51 (1.96%)      0/51 (0.00%)    
Social circumstances     
death  [1]  1/51 (1.96%)  1 0/51 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
One participant died as a result of unrelated causes
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Postplacental IUD Insertion Delayed IUD Insertion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/51 (5.88%)      0/51 (0.00%)    
Reproductive system and breast disorders     
vaginal laceration  [1]  1/51 (1.96%)  1 0/51 (0.00%)  0
retained IUD insertion tube  [2]  1/51 (1.96%)  1 0/51 (0.00%)  0
malpositioned IUD  [3]  1/51 (1.96%)  1 0/51 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
a participant who underwent a postplacental insertion experienced a vaginal laceration when the IUD strings were cut with scissors, requiring repair with suture
[2]
IUD insertion tube appeared to have detached from the IUD inserter and had been left inside her uterus during the postplacental IUD placement. Tihs was considered a complete expulsion for the analysis
[3]
IUD was positioned obliquely in the uterus with the arms of the IUD against the right uterine wall and the base of the IUD in the left cornua. Participant was asymptomatic.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principal Investigator
Organization: University of Pittsburgh
Phone: 412-641-5496
EMail: chenba@upmc.edu
Layout table for additonal information
Responsible Party: Beatrice Chen, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00476021     History of Changes
Other Study ID Numbers: PRO06070007
First Submitted: May 17, 2007
First Posted: May 21, 2007
Results First Submitted: December 1, 2014
Results First Posted: February 19, 2016
Last Update Posted: June 24, 2016