NCT03462758

Early vs. Interval Postpartum IUD Insertion

Early vs. Interval Postpartum IUD Insertion: A Multi-site Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Intrauterine devices (IUDs) are historically placed at a six-week postpartum visit for women who desire intrauterine contraception after delivery. A two-week postpartum visit could be a convenient time for women to receive contraception, including IUDs. Offering women IUDs at two-weeks postpartum may decrease the risk of undesired pregnancy and rapid repeat pregnancy. This study will compare IUD insertion at two different times after delivery: two-weeks and six-weeks postpartum. This will allow researchers to assess whether the timing of IUD placement affects whether an IUD is expelled, or pushed out of it's ideal location.

Detailed description

The purpose of this study is to determine the proportion of IUDs inserted in the Early Postpartum (EPP) period that are expelled at 6 months postpartum. This prospective, multi-site randomized trial will enroll approximately 404 women at three large academic hospitals in the United States. Women will be recruited who are interested in receiving a levonorgestrel-IUD or a copper-IUD after delivery. Postpartum women who desire an IUD will be randomized to EPP IUD insertion (between 14-28 days PP) or interval postpartum IUD insertion (42-56 days PP) and the proportion of IUDs expelled will be compared between groups at 6 months postpartum. All women will be seen in clinic at 6-8 weeks and 6 months postpartum. Women randomized to EPP IUD placement will be seen at 2-3 weeks postpartum. Provider perspectives of EPP IUD placement will also be evaluated, as will whether these attitudes change after 6 to 9 months of providing early postpartum IUDs.

Conditions

• Contraception

Interventions

Type	Name	Description
DEVICE	IUD	Postpartum IUD placement

Timeline

• Start date: 2018-03-20
• Primary completion: 2022-08-14
• Completion: 2022-12-31
• First posted: 2018-03-13
• Last updated: 2023-04-13
• Results posted: 2023-04-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study