Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device (IUD) After Vaginal Delivery (POPI)

May 17, 2016 updated by: Beatrice Chen, University of Pittsburgh

Randomized Trial of Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device After Vaginal Delivery

This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal delivery will be higher in women who have immediate postplacental insertion as compared to delayed insertion 6-8 weeks following delivery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The United States (US) has the highest unintended pregnancy rate of any developed country. Of the 6.4 million pregnancies in the US each year, almost half are unintended (49%). Roughly half of these (22% of all pregnancies) result in unintended births, while 20% of all pregnancies result in abortion. Postpartum women are particularly susceptible, with an unintended pregnancy rate of 10%-44% in the first year postpartum. These unintended pregnancies occur despite the recommendation that a contraceptive method be selected prior to hospital discharge.

Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The IUD is a highly effective but underused method of postpartum contraception. Although the expulsion rate in postplacental insertion is higher than interval insertion, the benefits of highly effective contraception available immediately after delivery may outweigh the risks of expulsion.

To date, there have been no randomized trials of postplacental insertion of the LNG-IUD in the United States. One pilot study in the United States of 20 subjects who received an ultrasound-guided postplacental insertion of the LNG-IUD showed an acceptable expulsion rate of 10% and no infections over a 10-week follow-up, thus making postplacental insertion of LNG-IUD safe for further study.

This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. One hundred sixty-eight women receiving prenatal care at Magee-Womens Hospital, Pittsburgh, PA, who are interested in using the LNG-IUD for contraception will be enrolled during their pregnancy. The IUD will be inserted within 10 minutes after delivery of the placenta in women randomized to immediate insertion. Delayed IUD insertion will be performed at the first postpartum visit in 6-8 weeks. All subjects will follow up in person at 6-8 weeks and 6 months after delivery. A telephone interview will occur at 3 months after delivery for all subjects.

Subjects who are not eligible for insertion due to post-randomization ineligibility criteria will be referred to their primary gynecologist or midwife for delayed IUD placement. They will be contacted by phone at 3 and 6 months to assess quality of life, contraceptive usage, and unintended pregnancy rates.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital, University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Greater than or equal to 24 0/7 weeks pregnant at time of enrollment
  • Anticipates undergoing a vaginal delivery
  • Desires to use the LNG-IUD (Mirena) for postpartum contraception
  • Willing and able to sign an informed consent in English
  • Willing to comply with the study protocol

Exclusion Criteria:

  • Planning to undergo a scheduled cesarean section
  • Allergy to either polyethylene or levonorgestrel or other contraindications to use of the LNG-IUD
  • Exposure to or treatment for gonorrhea, chlamydia, or trichomoniasis during the pregnancy
  • Presence of one or more leiomyomata greater than 3 centimeters in diameter
  • Uterine anomaly (other than a repaired septate uterus)
  • Current cervical cancer or carcinoma in-situ
  • Desires repeat pregnancy within one year of delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Postplacental IUD insertion
immediate postplacental levonorgestrel-releasing IUD (Mirena) insertion
Device: Levonorgestrel-releasing IUD (Mirena)
levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years
Other Names:
  • Mirena
Active Comparator: Delayed IUD insertion
delayed levonorgestrel-releasing IUD (Mirena) insertion (6-8 weeks after delivery)
Device: Levonorgestrel-releasing IUD (Mirena)
levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years
Other Names:
  • Mirena

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IUD Usage Rate at 6 Months
Time Frame: 6 months after delivery
Usage rate of the LNG-IUD at 6 months after delivery
6 months after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Women Who Are Able to Have the LNG-IUD Placed Postplacentally and Are Not Excluded From Placement
Time Frame: 6 months
6 months
Follow-up Rates for Delayed Insertion of LNG-IUD
Time Frame: 6 months
6 months
Expulsion Rates of Post-placental and Delayed Insertion of the LNG-IUD Using Clinical Exam and Ultrasonography
Time Frame: 6 months
6 months
Safety of Postplacental Insertion of the LNG-IUD as Measured by Infection Rates
Time Frame: 6 months
6 months
Rates of Follow-up and Unintended Pregnancy Rates for Subjects Who Are Excluded From Postpartum Insertion
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Beatrice A Chen, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

May 17, 2007

First Submitted That Met QC Criteria

May 17, 2007

First Posted (Estimate)

May 21, 2007

Study Record Updates

Last Update Posted (Estimate)

June 24, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO06070007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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