Clinical trial NCT00669396: Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
Official title: A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: contraception
emergency contraception
pregnancy prevention after unprotected intercourse
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-04-30
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.

Detailed description: This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree to study participation will be followed for 6 months. The primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for EC.

Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. Patients selecting the IUD will be assessed for IUD expulsion, perforation, and removal.

Eligibility criteria: Inclusion Criteria:

* Women 18-45 years old, in need of EC (had unprotected intercourse within 120 hours), willing to give consent for participation in research, willing to comply with the study requirements, and accessible by telephone.
* Patients selecting the IUD need to identify themselves as desiring long-term contraception.

Exclusion Criteria:

* Current pregnancy,
* Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days,
* Current behavior suggesting a high risk for pelvic inflammatory disease
* Allergy to copper, or Wilson's disease (for patients selecting Paragard) or allergy to levonorgestrel (for patients selecting Plan B)
* Intracavitary of symptomatic uterine fibroids, and abnormalities of the uterus that distort the uterine cavity,
* Mucopurulent cervicitis,
* A previously placed IUD that has not been removed
* Genital bleeding of unknown etiology
* Ovarian, cervical or endometrial cancer,
* Small uterine cavity

Primary outcomes:
measure: Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception
timeFrame: 6 months
Secondary outcomes:
measure: Pregnancy
timeFrame: 6 months
measure: Infection
timeFrame: 6 months
measure: IUD Expulsion, Removal, or Perforation
timeFrame: 6 months
Other outcomes:
Locations:
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/MPH
role: PRINCIPAL_INVESTIGATOR
References: