The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception
Information source: University of Utah
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy
Intervention: Copper T380 IUD (Drug); Oral levonorgestrel (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Utah Official(s) and/or principal investigator(s):
David Turok, MD, Principal Investigator, Affiliation: University of Utah
Overall contact:
David Turok, MD, Phone: 801-231-8516, Email: david.turok@hsc.utah.edu
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 Plan B for EC. The study will also compare use of an
effective method of contraception in the year after they received EC.
Clinical Details
Official title: Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception
Study design: Other, Prospective
Primary outcome: Unplanned pregnancy
Secondary outcome: Use of an effective method of contraception in the year following use of emergency contraception.IUD expulsion, removal or perforation
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Women 18-45 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)
Locations and Contacts
David Turok, MD, Phone: 801-231-8516, Email: david.turok@hsc.utah.edu
Planned Parenthood Association of Utah, West Valley City Clinic, West Valley City, Utah 84119-4715, United States
Planned Parenthood Association of Utah Salt Lake City Clinic, Salt Lake City, Utah 84102-3430, United States
Additional Information
Starting date: September 2009
Ending date: September 2011
Last updated: August 26, 2009
|
