Summary

for females ages 18 years and up (full criteria)
healthy people welcome
at La Jolla, California and other locations
study started
estimated completion:
Sarah Averbach

Description

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.

Official Title

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

Details

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 424 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.

Keywords

Contraception Mirena ParaGard Skyla Liletta Kyleena Intrauterine Device Intrauterine System Postpartum Expulsion IUD

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

  • 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 CDC Medical Eligibility Criteria
  • Suspicion for new pregnancy

Locations

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States
  • Naval Medical Center San Diego not yet accepting patients
    San Diego California 92134 United States

Lead Scientist

  • Sarah Averbach
    Assistant Adjunct Professor, Reproductive Medicine. Authored (or co-authored) 19 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03462758
Study Type
Interventional
Last Updated