- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01598662
Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement (IUD)
Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement: A Randomized, Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must be 15- 45 years of age and received their prenatal care at the University of Louisville OB/GYN clinic
- Planned vaginal delivery
- Negative third trimester cultures for Gonorrhea and Chlamydia
- Desire to use the IUD for contraception
Exclusion Criteria:
- Uterine anomalies
- Uterine or cervical neoplasia
- Past or current breast cancer
- Chorioamnionitis
- Acute liver disease
- Postpartum hemorrhage lasting greater than ten minutes or more than 500 mL blood loss
- Received prenatal other than at the University of Louisville OB/GYN Clinic
- Cesarean section
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1: IUD insertion 6 Weeks after delivery
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". |
The Mirena IUD is a levonorgestrel-releasing IUD which contains 52 mg levonorgestrel total and releases 20 mcg of hormone daily.
Other Names:
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Experimental: 2: Immediate Post-placental insertion
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. |
The Mirena IUD is a levonorgestrel-releasing IUD which contains 52 mg levonorgestrel total and releases 20 mcg of hormone daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IUD Expulsion Rate
Time Frame: 6 months
|
The investigators wanted to compare the expulsion rate of IUDs between the two treatment arms: immediate placement after placental delivery and interval placement 6 weeks after delivery.
IUD expulsion is confirmed by the inability of the physician to visualize the string attached to the IUD coming from the cervix.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mary E Stauble, MD, University of Louisville
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUD Study B090743
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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