Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement

NCT01598662 | Terminated Results DMC

• 1 other identifier: IUD Study B090743
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

IUD placement; contraception; postpartum; intrauterine device; expulsion

Outcome Measures

Primary Outcomes (1)

• IUD Expulsion Rate

  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.

  6 months

Study Arms (2)

1: IUD insertion 6 Weeks after delivery

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".

Device: Mirena (levonorgestrel-releasing intrauterine system)

2: Immediate Post-placental insertion

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.

Device: Mirena (levonorgestrel-releasing intrauterine system)

Interventions

Mirena (levonorgestrel-releasing intrauterine system) DEVICE

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

Also known as: Mirena IUD

1: IUD insertion 6 Weeks after delivery; 2: Immediate Post-placental insertion

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Results Point of Contact

• Title: Nancy Alsip
• Organization: University Louisville

nancy.alsip@louisville.edu

502-852-2905

Study Officials

• Mary E Stauble, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, University of Louisville School of Medicine, Department of Obstetrics, Gynecology & Women's Health, Generalist Division

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: May 15, 2012
• Study Start: July 1, 2009
• Primary Completion: March 21, 2011
• Study Completion: July 1, 2012
• Last Updated: September 25, 2018
• Results First Posted: July 26, 2018

Record last verified: 2018-08

Locations

US (1)