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Patient Compliance With Long-Acting Reversible Contraception Administration

Not Applicable
Terminated
Conditions
Contraception
Interventions
Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant
Registration Number
NCT03305081
Lead Sponsor
Tulane University School of Medicine
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.

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
45
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Immediate or early placementLevonorgestrel IUD, copper IUD, etonorgestrel implantImmediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum
Interval placementLevonorgestrel IUD, copper IUD, etonorgestrel implantInterval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant
Primary Outcome Measures
NameTimeMethod
Number of Women With Placement of LARC6 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
NameTimeMethod
Patient Satisfaction With Method of LARC Using LARC Survey6 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.

Trial Locations

Locations (1)

Tulane Department of Obstetrics and Gynecology

🇺🇸

New Orleans, Louisiana, United States

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