Patient Compliance With Long-Acting Reversible Contraception Administration

Tulane University School of Medicine

Status: Terminated

Conditions: Contraception

Treatments: Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant

Study type: Interventional

Funder types: Other

Identifiers

NCT03305081

IRBNet ID 628424-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

45 participants in 2 patient groups

Immediate or early placement

Experimental group

Description:

Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum

Treatment:

Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant

Interval placement

Active Comparator group

Description:

Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant

Treatment:

Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant