Patient Compliance With Long-Acting Reversible Contraception Administration

• Sponsor: Tulane University School of Medicine (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03305081
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.3
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

This a randomized control trial to identify if patients who desire LARC are more likely to have success receiving the desired form of contraception if it is placed a) during the postpartum hospital stay, either in the immediate or early postpartum period, versus b) during the interval postpartum period as previously done.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant	N/A

Detailed Description

Randomized control trial with control group receiving LARC at 6 weeks postpartum and the study group receiving LARC in the immediate or early postpartum period. Outcomes will be measured by those who receive or do not receive LARC either in the hospital after delivery versus 6 weeks postpartum in accordance with the study subjects' randomized designation. Secondary outcomes of bleeding profile and satisfaction will also be assessed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Patient Compliance With Long-Acting Reversible Contraception Administration Immediately and Early Postpartum Versus Interval Postpartum
• Actual Study Start Date: Oct 22, 2014
• Actual Primary Completion Date: Dec 21, 2015
• Actual Study Completion Date: May 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate or early placement Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum	Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant; Long-acting reversible contraception
Active Comparator: Interval placement Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant	Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant; Long-acting reversible contraception

Outcome Measures

Primary Outcome Measures

1. Number of Women With Placement of LARC [6 months]

   The outcome will be measured by the number of participants with LARC placement. The total number of women who expressed a desire to have postpartum contraception placed and randomized to the appropriate arm will be assessed.

Secondary Outcome Measures

1. Patient Satisfaction With Method of LARC Using LARC Survey [6 Weeks, 12 weeks postpartum, 6 months postpartum]

   Number of patients satisfied with LARC obtained by LARC survey at 6-weeks, 12-weeks postpartum, and 6 months postpartum. Patients identify Yes/No response via telephone survey asking, "Are you satisfied with this form of contraception?". Satisfaction determined if subject answers "Yes". A single value was calculated at the end of the study by summation at all three time points.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pregnant, desires LARC postpartum

Exclusion Criteria:

• Medical contraindication to desired LARC, vaginal delivery complicated by fourth degree perineal laceration, history of pelvic inflammatory disease, uterine infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tulane Department of Obstetrics and Gynecology	New Orleans	Louisiana	United States	70018

Sponsors and Collaborators

• Tulane University School of Medicine

Investigators

• Principal Investigator: Sara Junya, MD, Tulane University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tulane University School of Medicine
• ClinicalTrials.gov Identifier: NCT03305081
• Other Study ID Numbers: IRBNet ID 628424-1
• First Posted: Oct 9, 2017
• Last Update Posted: Jan 22, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Copper; Levonorgestrel

Study Results

Participant Flow

Arm/Group Title	Immediate or Early Placement	Interval Placement
Arm/Group Description	Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception	Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
Period Title: Overall Study
STARTED	25	20
COMPLETED	15	5
NOT COMPLETED	10	15

Baseline Characteristics

Arm/Group Title	Immediate or Early Placement	Interval Placement	Total
Arm/Group Description	Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception	Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception	Total of all reporting groups
Overall Participants	25	20	45
Age (Count of Participants)
<=18 years	2 8%	1 5%	3 6.7%
Between 18 and 65 years	23 92%	19 95%	42 93.3%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	25 100%	20 100%	45 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%	20 100%	45 100%
Patients Presenting to the Office or Hospital (Count of Participants)
Count of Participants [Participants]	25 100%	20 100%	45 100%

Outcome Measures

1. Primary Outcome

Title	Number of Women With Placement of LARC
Description	The outcome will be measured by the number of participants with LARC placement. The total number of women who expressed a desire to have postpartum contraception placed and randomized to the appropriate arm will be assessed.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immediate or Early Placement	Interval Placement
Arm/Group Description	Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception	Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
Measure Participants	25	20
Count of Participants [Participants]	10 40%	2 10%

2. Secondary Outcome

Title	Patient Satisfaction With Method of LARC Using LARC Survey
Description	Number of patients satisfied with LARC obtained by LARC survey at 6-weeks, 12-weeks postpartum, and 6 months postpartum. Patients identify Yes/No response via telephone survey asking, "Are you satisfied with this form of contraception?". Satisfaction determined if subject answers "Yes". A single value was calculated at the end of the study by summation at all three time points.
Time Frame	6 Weeks, 12 weeks postpartum, 6 months postpartum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immediate or Early Placement	Interval Placement
Arm/Group Description	Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception	Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
Measure Participants	25	15
Count of Participants [Participants]	10 40%	2 10%

Adverse Events

Arm/Group Title	Immediate or Early Placement		Interval Placement
Arm/Group Description	Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception		Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
All Cause Mortality
	Immediate or Early Placement		Interval Placement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Immediate or Early Placement		Interval Placement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Immediate or Early Placement		Interval Placement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/20 (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.