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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paula Bednarek, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00562276
First received: November 21, 2007
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Contraception
Procedure: Immediate IUD insertion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Immediate Versus Delayed IUD Insertion Following Suction Aspiration Between 5 and 12 Weeks Gestation: a Randomized Trial

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • IUD expulsion [ Time Frame: 1, 3 and 6 months after insertion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IUD continuation [ Time Frame: 1, 3 and 6 months after insertion ] [ Designated as safety issue: No ]

Enrollment: 578
Study Start Date: May 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Oregon Health and Science University

Additional 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
Study First Received: November 21, 2007
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014