Early Postpartum Intrauterine Device (IUD) Placement
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full 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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
201 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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