The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception

Completed

• Conditions: Pregnancy
• Interventions: Drug: Copper T380 IUD; Drug: Oral levonorgestrel

• Registration Number: NCT00966771
• Lead Sponsor: University of Utah

Brief Summary

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.

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 Timeline

• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Study Start: 2009-10
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2016-10
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 548

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IUD	Copper T380 IUD	Women presenting for emergency contraception who select the copper IUD
Oral levonorgestrel	Oral levonorgestrel	Women presenting for emergency contraception who select oral levonorgestrel

Primary Outcome Measures

Name	Time	Method
Unplanned pregnancy	within 12 months of presenting for EC

Secondary Outcome Measures

Name	Time	Method
Use of an effective method of contraception in the year following use of emergency contraception.	12 months
IUD expulsion, removal or perforation	12 months

Trial Locations

Locations (2)

Planned Parenthood Association of Utah, West Valley City Clinic; 🇺🇸 West Valley City, Utah, United States

Planned Parenthood Association of Utah Salt Lake City Clinic; 🇺🇸 Salt Lake City, Utah, United States