Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception|
- Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception [ Time Frame: 6 months ] [ Designated as safety issue: No ]Use of a method of contraception with a typical efficacy rate >= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.
- Pregnancy [ Time Frame: 6 months ] [ Designated as safety issue: No ]positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.
- Infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]diagnosis and treatment for pelvic inflammatory disease
- IUD Expulsion, Removal, or Perforation [ Time Frame: 6 months ] [ Designated as safety issue: No ]patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.
|Study Start Date:||April 2008|
|Study Completion Date:||May 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Drug: Copper T380 IUD
Copper T380 IUD
Other Name: Paragard IUD
Active Comparator: 2
Other Name: Plan B
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669396
|United States, Utah|
|Planned Parenthood Association of Utah, West Valley City Clinic|
|West Valley City, Utah, United States, 84119|
|Principal Investigator:||David Turok, MD/MPH||University of Utah|