Clinical trial NCT01594476: Early Postpartum Intrauterine Device (IUD) Placement
Official title: Early Versus Standard Interval Postpartum Intrauterine Device (IUD) Placement at 3 Weeks or 6 Weeks Following Delivery: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Contraception
Keywords: Postpartum
Contraception
Intrauterine device
Intrauterine system
Mirena
Paragard
Uterine involution
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2012-05-09
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead to negative consequences during the subsequent pregnancy. Providers have traditionally delayed starting birth control, especially placement of intrauterine devices (IUDs), post-delivery for a number of reasons. The first postpartum visit after a woman has given birth is typically scheduled for 6 weeks after her delivery, during which she is typically provided with her chosen method of birth control. This study will evaluate two different IUD placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to determine if placement time affects a woman's follow-through obtaining the IUD and keeping it inserted in place. The researchers will also look at bleeding patterns and patient/provider satisfaction with the IUD placement

Detailed description: The goal of this study is to investigate whether early interval placement of a postpartum IUD at 3 weeks postpartum, compared to the usual 6 weeks postpartum, is associated with greater uptake of the IUD by 3 months after delivery. Many women do not return for a follow up visit. We will investigate whether they are more likely to return and to receive an IUD if the follow up visit is earlier. Measures of 6 month IUD continuation, subject acceptability, safety and efficacy will also be examined. This prospective, randomized, controlled trial will enroll approximately 240 women at our academic tertiary care hospital in the United States. Participants will be recruited from women who deliver a live-born singleton infant at greater than 32 weeks gestation and who have indicated interest in obtaining intrauterine contraception. Subjects will choose to receive either a levonorgestrel-containing IUS (Mirena) or copper T380A IUD (ParaGard). Enrolled subjects will be randomized to IUD placement at either 3 weeks (+/- 3 days) or 6 weeks (+/- 3 days) after their delivery date. Women will be followed by phone contacts at 3 months and 4 months and will have a clinic visit with an ultrasound at 6 months after delivery. The IUD position in the uterus and the uterine size will be assessed at 6 months.

Eligibility criteria: Inclusion Criteria:

* Female
* 18 years or older
* Voluntarily requesting either copper T380A or levonorgestrel IUD placement for postpartum contraception
* Within 5 days of vaginal or cesarean delivery of live born infant ≥32 0/7 weeks at the time of enrollment
* English or Spanish speaking
* Able to give consent and agree to terms of the study
* No contraindications to use of either intrauterine device

Exclusion Criteria:

* Preterm delivery prior to 32 weeks gestation
* Recent pregnancy with multiple gestation
* Current incarceration
* Known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity
* Current or recent pelvic infection (chorioamnionitis treated for fever in labor only is not an exclusion)
* Suspected hypersensitivity or contraindication to the chosen IUD
* No insurance coverage for postpartum care, including Citizen Alien Waived Emergent Medical (CAWEM)

Primary outcomes:
measure: Subjects With an IUD at 3 Months Postpartum
timeFrame: Three months after delivery
Secondary outcomes:
measure: Satisfaction With the Timing of IUD Placement.
timeFrame: Immediately following IUD placement.
measure: Uterine Thickness at the Fundus
timeFrame: At IUD placement
measure: Subjects With an IUD at 6 Months Postpartum
timeFrame: Six months after delivery
measure: Number of Subjects With Adverse Events
timeFrame: Six months after delivery
measure: Pain With IUD Placement
timeFrame: At the time of IUD placement.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Maureen Baldwin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baldwin MK, Hart KD, Rodriguez MI. Predictors for follow-up among postpartum patients enrolled in a clinical trial. Contraception. 2018 Sep;98(3):228-231. doi: 10.1016/j.contraception.2018.04.016. Epub 2018 May 8.