Pregnancy Clinical Trial
Official title:
A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel 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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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