Overview

This trial is active, not recruiting.

Condition contraception
Treatment mirena (levonorgestrel-releasing intrauterine system)
Sponsor University of Louisville
Start date July 2009
End date June 2013
Trial size 70 participants
Trial identifier NCT01598662, IUD Study B090743

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Device:Levonorgestrel-releasing intrauterine device marketed as Mirena. Subjects randomized to interval placement will have their IUD placed in the office at six weeks postpartum or later. They must return for one visit within a month for a "string check".
mirena (levonorgestrel-releasing intrauterine system) Mirena IUD
The Mirena IUD is a levonorgestrel-releasing IUD which contains 52 mg levonorgestrel total and releases 20 mcg of hormone daily.
(Experimental)
Device: Levonorgestrel-releasing intrauterine device marketed as Mirena Subjects randomized to immediate post-placental placement within 10 minutes of delivery will have an IUD placed manually under sterile technique and with ultrasound guidance. An ultrasound will be performed within two days postpartum to verify proper placement and again at approximately six weeks postpartum.
mirena (levonorgestrel-releasing intrauterine system) Mirena IUD
The Mirena IUD is a levonorgestrel-releasing IUD which contains 52 mg levonorgestrel total and releases 20 mcg of hormone daily.

Primary Outcomes

Measure
expulsion rate
time frame: 6 months

Secondary Outcomes

Measure
uterine perforation
time frame: Time of insertion to 6 months post-partum
Intrauterine infection
time frame: 6 months
unintended pregnancy rates
time frame: 6 months
placement
time frame: 6 months
contraceptive maintenance
time frame: 6 months

Eligibility Criteria

Female participants from 15 years up to 45 years old.

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

Additional Information

Official title Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement: A Randomized, Controlled Trial
Principal investigator Mary E Stauble, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by University of Louisville.