Clinical trial NCT00966771: The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception
Official title: Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: contraception
emergency contraception
pregnancy prevention after unprotected intercourse
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Society of Family Planning
First posted: 2009-08-27
Enrollment: 548
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women presenting to family planning clinics for emergency contraception

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Unplanned pregnancy
timeFrame: within 12 months of presenting for EC
Secondary outcomes:
measure: Use of an effective method of contraception in the year following use of emergency contraception.
timeFrame: 12 months
measure: IUD expulsion, removal or perforation
timeFrame: 12 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Planned Parenthood Association of Utah Salt Lake City Clinic
state: Utah
city: West Valley City
country: United States
facility: Planned Parenthood Association of Utah, West Valley City Clinic
state: Utah
Study officials:
affiliation: University of Utah
name: David Turok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Royer PA, Turok DK, Sanders JN, Saltzman HM. Choice of Emergency Contraceptive and Decision Making Regarding Subsequent Unintended Pregnancy. J Womens Health (Larchmt). 2016 Oct;25(10):1038-1043. doi: 10.1089/jwh.2015.5625. Epub 2016 Mar 31.
citation: Torres LN, Turok DK, Sanders JN, Jacobson JC, Dermish AI, Ward K. We should really keep in touch: predictors of the ability to maintain contact with contraception clinical trial participants over 12 months. Contraception. 2014 Dec;90(6):575-80. doi: 10.1016/j.contraception.2014.07.013. Epub 2014 Aug 1.