Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement

NCT ID: NCT01598662

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-07-31

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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".

Group Type: ACTIVE_COMPARATOR

Mirena (levonorgestrel-releasing intrauterine system)

Intervention Type: DEVICE

The Mirena IUD is a levonorgestrel-releasing IUD which contains 52 mg levonorgestrel total and releases 20 mcg of hormone daily.

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.

Group Type: EXPERIMENTAL

Mirena (levonorgestrel-releasing intrauterine system)

Intervention Type: DEVICE

The Mirena IUD is a levonorgestrel-releasing IUD which contains 52 mg levonorgestrel total and releases 20 mcg of hormone daily.

Interventions

Mirena (levonorgestrel-releasing intrauterine system)

The Mirena IUD is a levonorgestrel-releasing IUD which contains 52 mg levonorgestrel total and releases 20 mcg of hormone daily.

Intervention Type: DEVICE

Other Intervention Names

Mirena IUD

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Mary Elaine Stauble

Assistant Professor, University of Louisville School of Medicine, Department of Obstetrics, Gynecology & Women's Health, Generalist Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary E Stauble, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

IUD Study B090743

Identifier Type: -

Identifier Source: org_study_id