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Trial record 4 of 3345 for:    Louisville

Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement (IUD)

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ClinicalTrials.gov Identifier: NCT01598662
Recruitment Status : Unknown
Verified May 2012 by Mary Elaine Stauble, University of Louisville.
Recruitment status was:  Active, not recruiting
First Posted : May 15, 2012
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
Mary Elaine Stauble, University of Louisville

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.

Condition or disease Intervention/treatment Phase
Contraception Device: Mirena (levonorgestrel-releasing intrauterine system) Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement: A Randomized, Controlled Trial
Study Start Date : July 2009
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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".

Device: 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.
Other Name: Mirena IUD
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.

Device: 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.
Other Name: Mirena IUD



Primary Outcome Measures :
  1. expulsion rate [ Time Frame: 6 months ]
    The investigators will be comparing the expulsion rate of IUDs between the two treatment arms, immediate placement after placental delivery and interval placement.


Secondary Outcome Measures :
  1. uterine perforation [ Time Frame: Time of insertion to 6 months post-partum ]
    One possible complication of IUD placement at any time is perforation of the uterine wall with projection of the IUD into or through the wall.

  2. Intrauterine infection [ Time Frame: 6 months ]
    An IUD is a foreign body and can be a nidus of infection. The most likely time frame for intrauterine infection with standard placement is within the first 20 days after placement. The investigators sought to compare the intrauterine infection rate between the two groups.

  3. unintended pregnancy rates [ Time Frame: 6 months ]
    Unintended pregnancy rates in immediate and delayed IUD insertions

  4. placement [ Time Frame: 6 months ]
    Investigators sought to determine the successful placement rate between immediate and interval IUD placement groups. In our indigent population, the majority of patients never return for a follow up visit and never implement this effective form of birth control.

  5. contraceptive maintenance [ Time Frame: 6 months ]
    Investigators will ascertain whether any form of birth control is being used at six months postpartum



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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598662


Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Mary E Stauble, MD University of Louisville

Responsible Party: Mary Elaine Stauble, Assistant Professor, University of Louisville School of Medicine, Department of Obstetrics, Gynecology & Women's Health, Generalist Division, University of Louisville
ClinicalTrials.gov Identifier: NCT01598662     History of Changes
Other Study ID Numbers: IUD Study B090743
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Mary Elaine Stauble, University of Louisville:
IUD placement
contraception
postpartum
intrauterine device
expulsion

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral