The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception (IUD EC)

February 2, 2017 updated by: David Turok, University of Utah

Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception

The purpose of this study is to see if women presenting for emergency contraception (EC) and choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next year compared to women who choose oral levonorgestrel for EC. The study will also compare use of an effective method of contraception in the year after they received EC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All women presenting to 2 Planned Parenthood Association of Utah clinics in Salt Lake City will be offered participation in this study. Women will select either the copper IUD or oral levonorgestrel for EC. The primary outcome is unplanned pregnancy in the year following presentation for EC.

Secondary outcomes include use of an effective method of contraception over the next year, abortions, repeat use of EC, number of days to first bleeding episode and duration of that bleeding episode, use of a barrier method to prevent sexually transmitted infections, patient satisfaction with the chosen method of EC and contraception. Participants selecting the IUD will be assessed for IUD expulsion, perforation, and removal.

Study Type

Observational

Enrollment (Actual)

548

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
    • Utah
      • Salt Lake City, Utah, United States, 84102-3430
        • Planned Parenthood Association of Utah Salt Lake City Clinic
      • West Valley City, Utah, United States, 84119-4715
        • Planned Parenthood Association of Utah, West Valley City Clinic

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 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women presenting to family planning clinics for emergency contraception

Description

Inclusion Criteria:

  • Women 18-30 years old,
  • in need of emergency contraception (had unprotected intercourse within 120 hours),
  • willing to give consent for participation in research,
  • willing to comply with study requirements, and
  • accessible by telephone.

Participants selecting the IUD need to identify themselves as desiring long-term contraception.

Exclusion Criteria:

  • Current pregnancy
  • Had pelvic inflammatory disease or septic abortion within the past 3 months or had gonorrhea or chlamydia infection in the last 60 days
  • Current behavior suggesting a high risk for pelvic inflammatory disease
  • Allergy to copper or Wilson's disease (for participants selecting the copper IUD) or allergy to levonorgestrel (for participants selecting oral levonorgestrel)
  • Abnormalities of the uterus that distort the uterine cavity
  • Mucopurulent cervicitis
  • A previously placed IUD that has not been removed
  • Genital bleeding of an unknown etiology
  • Ovarian, cervical, or endometrial cancer
  • Small uterine cavity (< 6cm)

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: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IUD
Women presenting for emergency contraception who select the copper IUD
Drug: Copper T380 IUD
copper T 380 IUD
Other Names:
  • Paragard IUD
Oral levonorgestrel
Women presenting for emergency contraception who select oral levonorgestrel
Drug: Oral levonorgestrel
1.5 mg
Other Names:
  • Plan B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Unplanned pregnancy
Time Frame: within 12 months of presenting for EC
within 12 months of presenting for EC

Secondary Outcome Measures

Outcome Measure
Time Frame
Use of an effective method of contraception in the year following use of emergency contraception.
Time Frame: 12 months
12 months
IUD expulsion, removal or perforation
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

University of Utah

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Society of Family Planning

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

October 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30937
  • 1R21HD063028-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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