Patient Compliance With Long-Acting Reversible Contraception Administration
- 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
- Pregnant, desires LARC postpartum
- 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
Group Intervention Description Immediate or early placement Levonorgestrel IUD, copper IUD, etonorgestrel implant Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum Interval placement Levonorgestrel IUD, copper IUD, etonorgestrel implant Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Tulane Department of Obstetrics and Gynecology
🇺🇸New Orleans, Louisiana, United States