Patient Compliance With Long-Acting Reversible Contraception Administration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Patient Compliance With Long-Acting Reversible Contraception Administration Immediately and Early Postpartum Versus Interval Postpartum

Conditions
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Contraception

Intervention / Treatment
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* Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate or early placement<br>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<br>* Long-acting reversible contraception<br>|
| Active Comparator: Interval placement<br>Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant | Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant<br>* Long-acting reversible contraception<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Women With Placement of LARC | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction With Method of LARC Using LARC Survey | 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. | 6 Weeks, 12 weeks postpartum, 6 months postpartum |