Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion

• Sponsor: University of Chicago (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00635362
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 69.1
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery.

Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Levonorgestrel-releasing intrauterine system (LNG-IUS); Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Immediate Post-placental Insertion of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean Delivery vs. 4-8 Week Post-delivery Interval Insertion: A Randomized Controlled Trial
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: postplacental insertion after cesarean Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)	Device: Levonorgestrel-releasing intrauterine system (LNG-IUS); Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta; Other Names: Mirena IUD
Active Comparator: delayed insertion group Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)	Device: Levonorgestrel-releasing intrauterine system (LNG-IUS); Insertion of the LNG-IUS 4-8 weeks after cesarean delivery; Other Names: Mirena IUD

Outcome Measures

Primary Outcome Measures

1. Use of the LNG-IUS for Contraception [12 months after cesarean delivery]

Secondary Outcome Measures

1. Rates of Expulsion of the LNG-IUS [12 months after cesarean delivery]

2. Perforation Rates [12 months after cesarean delivery]

3. Satisfaction With LNG-IUS [6 months after cesarean delivery]

   We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.

4. Satisfaction With LNG-IUS [12 months after cesarean delivery]

   We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pregnant at time of enrollment

• Planning to undergo a scheduled cesarean delivery

• Desires to use the LNG-IUS for contraception

• Willing and able to sign an informed consent in English

• Willing to comply with the study protocol

• Age greater than or equal to 18 years

• English speaking

Exclusion Criteria:

• Allergy to either polyethylene or levonorgestrel, or other contraindications to use of the LNG-IUS

• Positive testing for Gonorrhea, Chlamydia, or trichomoniasis during the pregnancy without treatment and a subsequent test of cure confirming a negative result

• Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the LNG-IUS

• Uterine anomaly which would not allow placement of the LNG-IUS

• Current cervical cancer or carcinoma in-situ

• Desire for repeat pregnancy in less than 12 months

• History of postabortal or postpartum sepsis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago

Investigators

• Principal Investigator: Melissa Gilliam, MD MPH, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Chicago Section of Family Planning and Contraceptive Research

Publications

None provided.

• Responsible Party: Melissa Gilliam, Chief, Section of Family Planning and Contraceptive Research, University of Chicago
• ClinicalTrials.gov Identifier: NCT00635362
• Other Study ID Numbers: 15148A
• First Posted: Mar 13, 2008
• Last Update Posted: May 13, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Melissa Gilliam, Chief, Section of Family Planning and Contraceptive Research, University of Chicago: Contraception; Contraceptive Devices; Intrauterine Devices; Unplanned Pregnancy; Postpartum Period
• Additional relevant MeSH terms: Levonorgestrel

Study Results

Participant Flow

Recruitment Details	Location: Two urban academic medical centers from both pre-natal and Labor & Delivery clinics Dates: May 2007-January 2011 Inclusion: Pregnant, English-speaking women, aged 18 years and older, with planned cesarean delivery, and desiring the LNG-IUS were eligible for the study.

Arm/Group Title	Delayed Insertion Group	Postplacental Insertion After Cesarean
Arm/Group Description	Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery	Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Period Title: Overall Study
STARTED	22	20
COMPLETED	9	12
NOT COMPLETED	13	8

Baseline Characteristics

Arm/Group Title	Delayed Insertion Group	Postplacental Insertion After Cesarean	Total
Arm/Group Description	Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery	Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta	Total of all reporting groups
Overall Participants	22	20	42
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	22 100%	20 100%	42 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.4 (5.3)	27.1 (6.2)	27.8 (5.7)
Sex: Female, Male (Count of Participants)
Female	22 100%	20 100%	42 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 13.6%	0 0%	3 7.1%
Not Hispanic or Latino	19 86.4%	20 100%	39 92.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	15 68.2%	14 70%	29 69%
White	4 18.2%	4 20%	8 19%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 13.6%	2 10%	5 11.9%
Region of Enrollment (participants) [Number]
United States	22 100%	20 100%	42 100%
Marital Status (participants) [Number]
Single	12 54.5%	10 50%	22 52.4%
Single, living with partner	1 4.5%	2 10%	3 7.1%
Married	9 40.9%	8 40%	17 40.5%
Annual Income (participants) [Number]
<$10,000	7 31.8%	6 30%	13 31%
$10,000-$30,000	6 27.3%	7 35%	13 31%
>$30,000	9 40.9%	7 35%	16 38.1%
Insurance Coverage (participants) [Number]
Medicaid	16 72.7%	14 70%	30 71.4%
Private	5 22.7%	6 30%	11 26.2%
Unknown/Not given	1 4.5%	0 0%	1 2.4%
Gestational Age at Delivery (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	38.3 (1.7)	38.4 (1.5)	38.4 (1.6)
Parity at Enrollment (participants) [Number]
0	1 4.5%	1 5%	2 4.8%
1	10 45.5%	7 35%	17 40.5%
2	8 36.4%	9 45%	17 40.5%
3 or more	3 13.6%	3 15%	6 14.3%

Outcome Measures

1. Primary Outcome

Title	Use of the LNG-IUS for Contraception
Time Frame	12 months after cesarean delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Delayed Insertion Group	Postplacental Insertion After Cesarean
Arm/Group Description	Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery	Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Measure Participants	22	20
Confirmed use of LNG-IUD	9 40.9%	12 60%
Lost to follow up at 12 months	8 36.4%	6 30%
Did not have IUD placed	4 18.2%	0 0%
Expelled prior to 12 months, not replaced	0 0%	2 10%
Removed per patient request	1 4.5%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Insertion Group, Postplacental Insertion After Cesarean
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.35
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Rates of Expulsion of the LNG-IUS
Time Frame	12 months after cesarean delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Delayed Insertion Group	Postplacental Insertion After Cesarean
Arm/Group Description	Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery	Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Measure Participants	22	20
Number [participants]	0 0%	4 20%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Insertion Group, Postplacental Insertion After Cesarean
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Perforation Rates
Time Frame	12 months after cesarean delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Delayed Insertion Group	Postplacental Insertion After Cesarean
Arm/Group Description	Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery	Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Measure Participants	22	20
Number [participants]	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Insertion Group, Postplacental Insertion After Cesarean
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.000
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	Satisfaction With LNG-IUS
Description	We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.
Time Frame	6 months after cesarean delivery

Outcome Measure Data

Analysis Population Description

Analysis only done on subject completing six-month visit

Arm/Group Title	Delayed Insertion Group	Postplacental Insertion After Cesarean
Arm/Group Description	Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery	Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Measure Participants	11	12
Number [participants]	7 31.8%	10 50%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Insertion Group, Postplacental Insertion After Cesarean
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.37
	Comments
	Method	Fisher Exact
	Comments

5. Secondary Outcome

Title	Satisfaction With LNG-IUS
Description	We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.
Time Frame	12 months after cesarean delivery

Outcome Measure Data

Analysis Population Description

Analysis only done on subjects completing 12-month visit

Arm/Group Title	Delayed Insertion Group	Postplacental Insertion After Cesarean
Arm/Group Description	Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery	Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Measure Participants	9	12
Number [participants]	9 40.9%	11 55%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Insertion Group, Postplacental Insertion After Cesarean
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Arm/Group Title	Delayed Insertion Group		Postplacental Insertion After Cesarean
Arm/Group Description	Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery		Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
All Cause Mortality
	Delayed Insertion Group		Postplacental Insertion After Cesarean
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Delayed Insertion Group		Postplacental Insertion After Cesarean
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Delayed Insertion Group		Postplacental Insertion After Cesarean
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/22 (9.1%)		1/20 (5%)
Infections and infestations
Chlamydia	0/22 (0%)	0	1/20 (5%)	1
Reproductive system and breast disorders
Menorrhagia	2/22 (9.1%)	2	0/20 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.