Early vs. Interval Postpartum IUD Insertion (EPPIUD)

University of California San Diego

Status

Completed

Conditions

Contraception

Treatments

Device: IUD

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT03462758

172101

Details and patient eligibility

About

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.

Full 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.

Enrollment

404 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Gave birth less than or equal to 10 days ago
Desires to use an IUD for Contraception (either copper or levonorgestrel)
Willing and able to sign an informed consent
Willing to comply with the study protocol
Age greater than or equal to 18 years
English or Spanish speaking

Exclusion criteria

Uterine anomaly or leiomyomata which would not allow placement of an IUD
Desire for repeat pregnancy in less than 6 months
Evidence of intrauterine infection (chorioamnionitis or postpartum endometritis) treated with antibiotics
Ruptured uterus at the time of delivery
Received a postpartum tubal ligation or immediate postpartum IUD or implant at delivery
Incarcerated women or women with significant cognitive impairment
4th degree perineal laceration sustained at delivery
Any medical contraindication to IUD per the US Centers for Disease Control (CDC) Medical Eligibility Criteria
Suspicion for new pregnancy