Clinical trial NCT03462758: Early vs. Interval Postpartum IUD Insertion
Official title: Early vs. Interval Postpartum IUD Insertion: A Multi-site Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Mirena
ParaGard
Skyla
Liletta
Kyleena
Intrauterine Device
Intrauterine System
Postpartum
Expulsion
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of New Mexico
name: United States Naval Medical Center, San Diego
name: University of Illinois at Chicago
name: University of Chicago
First posted: 2018-03-13
Enrollment: 404
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Participants With an IUD Expulsion (Complete) at 6 Months
timeFrame: 6 months postpartum
Secondary outcomes:
measure: Proportion of Participants Using an IUD at 6 Months
timeFrame: 6 months postpartum
measure: Proportion of Participants With an IUD Expulsion (Partial) at 6 Months
timeFrame: 6 months
measure: Proportion of Participants With a Pelvic Infection Within 6 Months
timeFrame: 6 months
measure: Patient Satisfaction With IUD Assessed on a Five-point "Likert" Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement
timeFrame: 6 months
measure: Proportion of Participants With an IUD Perforation at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of California, San Diego
name: Sarah Averbach, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: