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Trial record 5 of 393 for:    LEVONORGESTREL

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
Name/Title: Dr. David Turok
Organization: University of Utah, Department of OBGYN
Phone: 801-581-6170
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