Immediate Versus Delayed Intrauterine Device (IUD) Insertion Following First Trimester Suction Aspiration Procedures (PAIR)
This study has been completed.
Sponsor:
Oregon Health and Science University
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
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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:
- the expulsion rates measured at 1, 3 and 6 months will be clinically equivalent with immediate insertion compared with delayed insertion,
- satisfaction and tolerance of side effects will be higher with immediate IUD insertion compared with delayed insertion, and
- 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 Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Further study details as provided by Paula Bednarek, Oregon Health and Science University:
Primary Outcome Measures:
- IUD expulsion [ Time Frame: 1, 3 and 6 months after insertion ]
Secondary Outcome Measures:
- IUD continuation [ Time Frame: 1, 3 and 6 months after insertion ]
| 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 (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
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
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
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 |
Keywords provided by Paula Bednarek, Oregon Health and Science University:
|
IUD insertion timing |
Additional relevant MeSH terms:
|
Polystyrene sulfonic acid Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 25, 2017