Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study

June 27, 2019 updated by: University of Colorado, Denver

The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form of contraception. The postpartum period is an important moment for contraceptive intervention; however there are many barriers to women obtaining birth control postpartum. The use of the IUD in the immediate postpartum setting offers many advantages and is considered safe, but the risk of expulsion appears to be higher than with interval insertion. Previous studies have shown the rate of expulsion of the copper IUD in the postplacental period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While studies related to the copper IUD use ring forceps or the operator's hand for placement of the IUD, the only published study investigating immediate postplacental levonorgestrel IUD insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore ask the question, is there a difference in expulsion rates between levonorgestrel and copper IUDs placed post-placentally when all providers undergo a standardized training, use a standardized insertion technique, and when patient level characteristics are controlled by randomization?

The investigators propose to perform a prospective cohort trial comparing the rates of expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the uterus within 10 minutes of the delivery of the placenta, using a standardized technique (placement with a ring forceps or the operator's hand) after all providers undergo a formal didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has a higher rate of expulsion as compared to the copper IUD. Additional objectives include a comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the investigators will document the natural history of the location of the IUD within the uterus when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks, and 3 months postpartum, to better understand the relationship between position of the IUD and subsequent expulsion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

123

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
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

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 to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women interested in an immediate postpartum IUD, or those who recently had one placed, who are willing to be followed postpartum.

Description

Inclusion Criteria:

  • Women age ≥ 18
  • Desire for immediate postpartum IUD or postpartum day #1 after a postplacental IUD placement
  • English or Spanish speaking
  • Willing to attend 2 follow-up visits

Exclusion Criteria:

  • Multiple gestations
  • Delivery prior to 35 weeks gestational age
  • Allergy or sensitivity to any component of either IUD (including polyethylene, levonorgestrel or copper)
  • Cesarean delivery
  • Postpartum hemorrhage (estimated blood loss > 500 mL)
  • Chorioamnionitis
  • Abnormal uterine anatomy (including uterine anomaly or large fibroids)
  • Treated for Chlamydia or Gonorrhea during pregnancy without a subsequent negative follow-up test
  • Current cervical cancer or carcinoma in situ
  • Current breast cancer
  • Wilson's disease
  • If enrolling postpartum after IUD has already been placed, women will be excluded if the provider used an insertion technique other than using the ring forceps or the operator's hand

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mirena Group
Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Drug: Mirena
The IUD will be placed as part of standard clinical care.
Other Names:
  • LNG-IUS, IUD
Paragard Group
Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Device: Paragard
The IUD will be placed as part of standard clinical care.
Other Names:
  • T380A IUD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IUD Expulsion Rate
Time Frame: 3 months postpartum
The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.
3 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy
Time Frame: 6 weeks
A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated.
6 weeks
Pregnancy
Time Frame: 3 months
A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated.
3 months
Complications
Time Frame: 3 months
A questionnaire will be administered to determine if the participant has had any complications since placement. Number of women reporting complications are reported.
3 months
Satisfaction
Time Frame: 3 months
A questionnaire will be administered to determine the participant's satisfaction level with the IUD. Satisfaction levels of >= 8 are reported by percent of participants.
3 months
Intrauterine Device Expulsion (Day 1)
Time Frame: Day 1
Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound.
Day 1
Intrauterine Device Expulsion (6 Weeks)
Time Frame: 6 weeks
Number of expulsions. Position of the IUD within the uterus will be documented by ultrasound.
6 weeks
Intrauterine Device Expulsion by 12 Weeks Postpartum
Time Frame: 12 weeks
Position of the IUD within the uterus will be documented by ultrasound.
12 weeks

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Stephanie Teal, MD, University of Colorado, Denver

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

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

April 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-3264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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