The purpose of this multi-center clinical trial is to evaluate the safety and effectiveness of inserting an intrauterine device (IUD) immediately after a suction aspiration procedure compared to inserting the IUD 2-6 weeks after the procedure. This study will also evaluate how satisfied women are with the timing of their IUD placement. Subjects will be able to choose between the Paraguard IUD or the Mirena IUD. The researchers hypothesize that: 1. the expulsion rates measured at 1, 3 and 6 months will be clinically equivalent with immediate insertion compared with delayed insertion, 2. satisfaction and tolerance of side effects will be higher with immediate IUD insertion compared with delayed insertion, and 3. overall IUD use/continuation rates measured at 1, 3 and 6 months will be higher with immediate IUD insertion compared with delayed insertion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
578
Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation
Emory University
Atlanta, Georgia, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
IUD expulsion
Time frame: 1, 3 and 6 months after insertion
IUD continuation
Time frame: 1, 3 and 6 months after insertion
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