Clinical trial NCT01598662: Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement
Official title: Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Contraception
Keywords: IUD placement
contraception
postpartum
intrauterine device
expulsion
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 32
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is randomized controlled trial designed for pregnant women who deliver vaginally at the University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted for postpartum contraception. After informed consent is obtained, eligible study participants will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10 minutes of delivery of the placenta following a normal vaginal delivery. The investigators seek to determine the expulsion rate and complication rate in subjects with IUD immediately after placental delivery compared to insertion at six weeks postpartum or later. The investigators hypothesize that immediate placement safe and has an acceptably low expulsion rate to merit earlier placement in the indigent population.

Detailed description: Unintended pregnancy occurs in nearly half of all pregnancies in the United States. There are many barriers to implementation of long-term reversible contraception in the immediate postpartum period. In our indigent population, a survey of patients showed that nearly 60% of patients who chose an IUD while admitted postpartum never returned for placement, placing them at risk for early repeat pregnancy.

The intrauterine device is a safe and effective form of long-term reversible contraception when placed at 6 weeks postpartum or later with pregnancy rates of only 0.1%. The commercially available Mirena IUD contains levonorgestrel which is released slowly over five years, providing safe, reversible contraception and making menstrual flow much lighter.

This randomized controlled trial will compare traditional placement at 6 weeks or more postpartum versus immediate post-placental placement.

The investigators hypothesize that the expulsion rate of IUDs placed immediately postpartum will be acceptably low in an indigent population to still be cost effective. Studies from the world literature in Egypt and Mexico where IUDs are routinely placed immediately following placental delivery.support this hypothesis. A recent study published in 2010 by Chen et al. showed an approximately 24% expulsion rate.

Six week postpartum IUD placement for contraception will be compared to immediate post-placental IUD placement, to determine whether immediate IUD insertion after delivery has an acceptably low rate of expulsion, infection, perforation and unintended pregnancy, and a high rate of retention, patient satisfaction, and maintenance of contraception.

Eligibility criteria: Inclusion Criteria:

1. Patients must be 15- 45 years of age and received their prenatal care at the University of Louisville OB/GYN clinic
2. Planned vaginal delivery
3. Negative third trimester cultures for Gonorrhea and Chlamydia
4. Desire to use the IUD for contraception

Exclusion Criteria:

1. Uterine anomalies
2. Uterine or cervical neoplasia
3. Past or current breast cancer
4. Chorioamnionitis
5. Acute liver disease
6. Postpartum hemorrhage lasting greater than ten minutes or more than 500 mL blood loss
7. Received prenatal other than at the University of Louisville OB/GYN Clinic
8. Cesarean section

Primary outcomes:
measure: IUD Expulsion Rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Mary E Stauble, MD
role: PRINCIPAL_INVESTIGATOR
References: