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Trial record 59 of 404 for:    LEVONORGESTREL

Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study

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ClinicalTrials.gov Identifier: NCT02067663
Recruitment Status : Completed
First Posted : February 20, 2014
Results First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Contraception
Interventions Device: Paragard
Drug: Mirena
Enrollment 123
Recruitment Details This prospective cohort trial was conducted at 2 affiliated teaching hospitals: University of Colorado Hospital (UCH) in Aurora, CO, and Denver Health Medical Center (DHMC) in Denver, CO.
Pre-assignment Details  
Arm/Group Title Mirena Group Paragard Group
Hide Arm/Group Description

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Mirena: The IUD will be placed as part of standard clinical care.

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

Paragard: The IUD will be placed as part of standard clinical care.

Period Title: Overall Study
Started 68 55
Completed 55 41
Not Completed 13 14
Reason Not Completed
Lost to Follow-up             13             14
Arm/Group Title Mirena Group Paragard Group Total
Hide Arm/Group Description

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Mirena: The IUD will be placed as part of standard clinical care.

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

Paragard: The IUD will be placed as part of standard clinical care.

Total of all reporting groups
Overall Number of Baseline Participants 68 55 123
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 55 participants 123 participants
26.2  (5.3) 27.4  (5.4) 26.72  (5.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 55 participants 123 participants
Female
68
 100.0%
55
 100.0%
123
 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 68 participants 55 participants 123 participants
Hispanic or Latino
26
  38.2%
36
  65.5%
62
  50.4%
Not Hispanic or Latino
42
  61.8%
19
  34.5%
61
  49.6%
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 68 participants 55 participants 123 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
19
  27.9%
9
  16.4%
28
  22.8%
White
38
  55.9%
36
  65.5%
74
  60.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
11
  16.2%
10
  18.2%
21
  17.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 68 participants 55 participants 123 participants
68 55 123
1.Primary Outcome
Title IUD Expulsion Rate
Hide Description The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.
Time Frame 3 months postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirena Group Paragard Group
Hide Arm/Group Description:

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Mirena: The IUD will be placed as part of standard clinical care.

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

Paragard: The IUD will be placed as part of standard clinical care.

Overall Number of Participants Analyzed 55 41
Measure Type: Count of Participants
Unit of Measure: Participants
20
  36.4%
7
  17.1%
2.Secondary Outcome
Title Pregnancy
Hide Description A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirena Group Paragard Group
Hide Arm/Group Description:

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Mirena: The IUD will be placed as part of standard clinical care.

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

Paragard: The IUD will be placed as part of standard clinical care.

Overall Number of Participants Analyzed 56 45
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Pregnancy
Hide Description A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirena Group Paragard Group
Hide Arm/Group Description:

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Mirena: The IUD will be placed as part of standard clinical care.

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

Paragard: The IUD will be placed as part of standard clinical care.

Overall Number of Participants Analyzed 56 45
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Complications
Hide Description A questionnaire will be administered to determine if the participant has had any complications since placement. Number of women reporting complications are reported.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirena Group Paragard Group
Hide Arm/Group Description:

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Mirena: The IUD will be placed as part of standard clinical care.

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

Paragard: The IUD will be placed as part of standard clinical care.

Overall Number of Participants Analyzed 55 41
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Satisfaction
Hide Description A questionnaire will be administered to determine the participant's satisfaction level with the IUD. Satisfaction levels of >= 8 are reported by percent of participants.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirena Group Paragard Group
Hide Arm/Group Description:

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Mirena: The IUD will be placed as part of standard clinical care.

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

Paragard: The IUD will be placed as part of standard clinical care.

Overall Number of Participants Analyzed 35 34
Measure Type: Number
Unit of Measure: percent of participants
91.4 94.2
6.Secondary Outcome
Title Intrauterine Device Expulsion (Day 1)
Hide Description Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirena Group Paragard Group
Hide Arm/Group Description:

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Mirena: The IUD will be placed as part of standard clinical care.

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

Paragard: The IUD will be placed as part of standard clinical care.

Overall Number of Participants Analyzed 56 45
Measure Type: Number
Unit of Measure: participants
0 0
7.Secondary Outcome
Title Intrauterine Device Expulsion (6 Weeks)
Hide Description Number of expulsions. Position of the IUD within the uterus will be documented by ultrasound.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirena Group Paragard Group
Hide Arm/Group Description:

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Mirena: The IUD will be placed as part of standard clinical care.

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

Paragard: The IUD will be placed as part of standard clinical care.

Overall Number of Participants Analyzed 56 45
Measure Type: Number
Unit of Measure: participants
18 6
8.Secondary Outcome
Title Intrauterine Device Expulsion by 12 Weeks Postpartum
Hide Description Position of the IUD within the uterus will be documented by ultrasound.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirena Group Paragard Group
Hide Arm/Group Description:

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Mirena: The IUD will be placed as part of standard clinical care.

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

Paragard: The IUD will be placed as part of standard clinical care.

Overall Number of Participants Analyzed 55 41
Measure Type: Count of Participants
Unit of Measure: Participants
21
  38.2%
8
  19.5%
Time Frame Adverse event information was collected from the time of consent until completion of participation (12 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mirena Group Paragard Group
Hide Arm/Group Description

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Mirena: The IUD will be placed as part of standard clinical care.

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

Paragard: The IUD will be placed as part of standard clinical care.

All-Cause Mortality
Mirena Group Paragard Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mirena Group Paragard Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   0/55 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mirena Group Paragard Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   0/55 (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
Layout table for Results Point of Contact information
Name/Title: Lisa Goldthwaite
Organization: Stanford University School of Medicine
Phone: 541-515-1825
EMail: lgoldthw@stanford.edu
Publications:
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02067663     History of Changes
Other Study ID Numbers: 13-3264
First Submitted: February 11, 2014
First Posted: February 20, 2014
Results First Submitted: May 25, 2018
Results First Posted: July 4, 2019
Last Update Posted: July 4, 2019