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

Utah System of Higher Education (USHE)

Status

Completed

Conditions

Pregnancy

Treatments

Drug: Oral levonorgestrel

Drug: Copper T380 IUD

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT00966771

30937

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

Details and patient eligibility

About

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.

Full 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.

Enrollment

548 patients

Sex

Female

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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)