BLIS - Breastfeeding Levonorgestrel IUD Study (BLIS)

• 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: University of Utah
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Early IUD Insertion Group	Standard Postpartum Insertion Group
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

Baseline Characteristics

Arm/Group Title		Early IUD Insertion Group	Standard Postpartum Insertion Group	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Breastfeeding Continuation Rates at 8 Weeks Postpartum
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

Outcome Measure Data

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
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
Description	To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.
Time Frame	First 5 days after birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Early IUD Insertion Group	Standard Postpartum Insertion Group
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Early IUD Insertion Group		Standard Postpartum Insertion Group
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	--/--		--/--
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.
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.

Limitations and Caveats

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.

More Information

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
• EMail: david.turok@hsc.utah.edu

• 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