Status:
COMPLETED
Early vs. Interval Postpartum IUD Insertion
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
University of New Mexico
United States Naval Medical Center, San Diego
Conditions:
Contraception
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 tim...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT03462758
Start Date
March 20 2018
End Date
December 31 2022
Last Update
April 13 2023
Active Locations (4)
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1
University of California, San Diego
La Jolla, California, United States, 92093
2
Naval Medical Center San Diego
San Diego, California, United States, 92134
3
University of Illinois at Chicago
Chicago, Illinois, United States, 60607
4
University of New Mexico
Albuquerque, New Mexico, United States, 87131