Contraception
Conditions
Keywords
IUD, insertion timing
Brief summary
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.
Interventions
PROCEDUREImmediate IUD insertion
Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * 18 years or older * Requesting suction aspiration for spontaneous or elective abortion * Intrauterine pregnancy documented with ultrasound. For women with a gestational sac, the gestational age (EGA) must be ≥ 5 weeks 0 days but ≤ 12 weeks 0 days based on the following criteria: * If no embryonic pole present: EGA (days) = mean sac diameter (mm) + 30 (Mean sac diameter =\[length+width+depth\]/3) * If embryonic pole is present: EGA (days) determined by Hadlock scale for measured crown-rump length * Desiring intrauterine contraception * In general good health * Willing and able to undergo informed consent * Willing to comply with randomization and study follow-up schedule
Exclusion criteria
* Pelvic exam with evidence of active cervicitis or PID (eg. purulent discharge, adnexal mass, significant cervical or uterine tenderness) * PID or sexually transmitted infection within the previous three months * History of pelvic Actinomyces * Unexplained vaginal bleeding * Uterine anomaly (eg. bicornuate uterus) * Leiomyomata that distort the uterine cavity * Known or suspected complete molar pregnancy * Current confirmed or possible ectopic pregnancy * AIDS without treatment (individuals with HIV/AIDS who are clinically well are not excluded) * Any prior surgical aspiration during this current pregnancy * Use of osmotic dilators (eg. laminaria) or misoprostol for cervical preparation during the aspiration procedure * Allergy to polyethylene * Allergy to levonorgestrel (for levonorgestrel-containing IUS only) * Allergy to copper (for copper T380A IUD only) * Wilson's disease (for copper T380A IUD only) * Current participation in another research study which would interfere with the conduct of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IUD expulsion | 1, 3 and 6 months after insertion |
Secondary
| Measure | Time frame |
|---|---|
| IUD continuation | 1, 3 and 6 months after insertion |
Countries
United States
Outcome results
None listed