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Immediate Versus Delayed Intrauterine Device (IUD) Insertion Following First Trimester Suction Aspiration Procedures (PAIR)

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ClinicalTrials.gov Identifier: NCT00562276
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : September 14, 2012
Sponsor:
Information provided by (Responsible Party):
Paula Bednarek, Oregon Health and Science University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Contraception Procedure: Immediate IUD insertion Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 578 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Immediate Versus Delayed IUD Insertion Following Suction Aspiration Between 5 and 12 Weeks Gestation: a Randomized Trial
Study Start Date : May 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Immediate IUD insertion following suction aspiration between 5 and 12 weeks gestation
 Procedure: Immediate IUD insertion
Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation
No Intervention: 2
Delayed IUD insertion 2-6 weeks following suction aspiration between 5 and 12 weeks gestation


Outcome Measures
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Primary Outcome Measures :
  1. IUD expulsion [ Time Frame: 1, 3 and 6 months after insertion ]

Secondary Outcome Measures :
  1. IUD continuation [ Time Frame: 1, 3 and 6 months after insertion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562276


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States
United States, Pennsylvania
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Paula H Bednarek, MD Oregon Health and Science University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paula Bednarek, Assistant Professor SM.OB/GYN Generalist Division, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00562276     History of Changes
Other Study ID Numbers: OHSU FAMPLAN 2535
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: September 14, 2012
Last Verified: September 2012

Keywords provided by Paula Bednarek, Oregon Health and Science University:
IUD
insertion timing