Immediate Versus Delayed Intrauterine Device (IUD) Insertion Following First Trimester Suction Aspiration Procedures
PAIR
Immediate Versus Delayed IUD Insertion Following Suction Aspiration Between 5 and 12 Weeks Gestation: a Randomized Trial
1 other identifier
interventional
578
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2007
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 21, 2007
CompletedFirst Posted
Study publicly available on registry
November 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedSeptember 14, 2012
September 1, 2012
2.1 years
November 21, 2007
September 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IUD expulsion
1, 3 and 6 months after insertion
Secondary Outcomes (1)
IUD continuation
1, 3 and 6 months after insertion
Study Arms (2)
1
EXPERIMENTALImmediate IUD insertion following suction aspiration between 5 and 12 weeks gestation
2
NO INTERVENTIONDelayed IUD insertion 2-6 weeks following suction aspiration between 5 and 12 weeks gestation
Interventions
Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation
Eligibility Criteria
You may qualify if:
- Female
- 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
You may not qualify if:
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
Related Publications (2)
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.
PMID: 25487172DERIVEDBednarek 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.
PMID: 21651392DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Paula H Bednarek, MD
Oregon Health and Science University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor SM.OB/GYN Generalist Division
Study Record Dates
First Submitted
November 21, 2007
First Posted
November 22, 2007
Study Start
May 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
September 14, 2012
Record last verified: 2012-09