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BLIS - Breastfeeding Levonorgestrel IUD Study (BLIS)

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ClinicalTrials.gov Identifier: NCT01990703
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
Society of Family Planning
University of New Mexico
Information provided by (Responsible Party):
David Turok, University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Contraception
Intervention Drug: Levonorgestrel IUD
Enrollment 285
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early IUD Insertion Group Standard Postpartum Insertion Group
Hide Arm/Group Description

Immediate post-placental placement of the levonorgestrel IUD

Levonorgestrel IUD: Timing of IUD insertion

Placement of the levonorgestrel IUD 4-6 weeks postpartum

Levonorgestrel IUD: Timing of IUD insertion

Period Title: Overall Study
Started 147 138
Completed 108 93
Not Completed 39 45
Arm/Group Title Early IUD Insertion Group Standard Postpartum Insertion Group Total
Hide Arm/Group Description

Immediate post-placental placement of the levonorgestrel IUD

Levonorgestrel IUD: Timing of IUD insertion

Placement of the levonorgestrel IUD 4-6 weeks postpartum

Levonorgestrel IUD: Timing of IUD insertion

Total of all reporting groups
Overall Number of Baseline Participants 147 138 285
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 138 participants 285 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
147
 100.0%
138
 100.0%
285
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants 138 participants 285 participants
28.6  (5.4) 28.1  (5.6) 28.4  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 138 participants 285 participants
Female
147
 100.0%
138
 100.0%
285
 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 147 participants 138 participants 285 participants
147 138 285
1.Primary Outcome
Title Breastfeeding Continuation Rates at 8 Weeks Postpartum
Hide Description To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.
Time Frame 8 weeks postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
147 Early IUD Insertion participants at baseline drops to 112 at 8 weeks due to exclusions for medical complications (n=15), inability to provide immediate IUD (n=7) and loss to follow up (n=13). In the Standard Insertion group 138 at baseline drops to 102 at 8 weeks with medical comps (n=11), failure to receive IUD (n=24), and 1 loss to follow up.
Arm/Group Title Early IUD Insertion Group Standard Postpartum Insertion Group
Hide Arm/Group Description:

Immediate post-placental placement of the levonorgestrel IUD

Levonorgestrel IUD: Timing of IUD insertion

Placement of the levonorgestrel IUD 4-6 weeks postpartum

Levonorgestrel IUD: Timing of IUD insertion

Overall Number of Participants Analyzed 112 102
Measure Type: Count of Participants
Unit of Measure: Participants
88
  78.6%
86
  84.3%
2.Secondary Outcome
Title Time to Lactogenesis Stage 2
Hide Description To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.
Time Frame First 5 days after birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early IUD Insertion Group Standard Postpartum Insertion Group
Hide Arm/Group Description:

Immediate post-placental placement of the levonorgestrel IUD

Levonorgestrel IUD: Timing of IUD insertion

Placement of the levonorgestrel IUD 4-6 weeks postpartum

Levonorgestrel IUD: Timing of IUD insertion

Overall Number of Participants Analyzed 125 103
Mean (Standard Deviation)
Unit of Measure: Hours
65.3  (25.7) 63.6  (21.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Early IUD Insertion Group Standard Postpartum Insertion Group
Hide Arm/Group Description

Immediate post-placental placement of the levonorgestrel IUD

Levonorgestrel IUD: Timing of IUD insertion

Placement of the levonorgestrel IUD 4-6 weeks postpartum

Levonorgestrel IUD: Timing of IUD insertion

All-Cause Mortality
Early IUD Insertion Group Standard Postpartum Insertion Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Early IUD Insertion Group Standard Postpartum Insertion Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/147 (0.68%)      0/138 (0.00%)    
Psychiatric disorders     
Suicidal behavior  [1]  1/147 (0.68%)  1 0/138 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Participant hospitalized for suicidal behavior and lacerations after a history of severe recurrent depression.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Early IUD Insertion Group Standard Postpartum Insertion Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/147 (0.68%)      0/138 (0.00%)    
Gastrointestinal disorders     
Cholangitis  [1]  1/147 (0.68%)  1 0/138 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Participant hospitalized for acute cholangitis with stone removal surgery performed.
Inability to blind, loss to follow-up, and lack of long-term infant and childhood outcomes. We had a smaller final sample than intended despite meeting enrollment goals.
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: Dr. David Turok
Organization: University of Utah, Department of OBGYN
Phone: 801-581-6170
EMail: david.turok@hsc.utah.edu
Layout table for additonal information
Responsible Party: David Turok, University of Utah
ClinicalTrials.gov Identifier: NCT01990703     History of Changes
Other Study ID Numbers: 62844
First Submitted: November 15, 2013
First Posted: November 21, 2013
Results First Submitted: March 27, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017