Immediate Versus Delayed Intrauterine Device (IUD) Insertion Following First Trimester Suction Aspiration Procedures
NCT ID: NCT00562276
Last Updated: 2012-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
578 participants
INTERVENTIONAL
2007-05-31
2009-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
Immediate IUD insertion following suction aspiration between 5 and 12 weeks gestation
Immediate IUD insertion
Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation
2
Delayed IUD insertion 2-6 weeks following suction aspiration between 5 and 12 weeks gestation
No interventions assigned to this group
Interventions
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Immediate IUD insertion
Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Paula Bednarek
Assistant Professor SM.OB/GYN Generalist Division
Principal Investigators
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Paula H Bednarek, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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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
Countries
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References
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Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT; Post-Aspiration IUD Randomization (PAIR) Study Trial Group. Prophylactic ibuprofen does not improve pain with IUD insertion: a randomized trial. Contraception. 2015 Mar;91(3):193-7. doi: 10.1016/j.contraception.2014.11.012. Epub 2014 Nov 25.
Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT; Post-Aspiration IUD Randomization (PAIR) Study Trial Group. Immediate versus delayed IUD insertion after uterine aspiration. N Engl J Med. 2011 Jun 9;364(23):2208-17. doi: 10.1056/NEJMoa1011600.
Other Identifiers
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OHSU FAMPLAN 2535
Identifier Type: -
Identifier Source: org_study_id