ContraceptionPhase 4PAIRNCT00562276
Immediate Versus Delayed Intrauterine Device (IUD) Insertion Following First Trimester Suction Aspiration Procedures
A Phase 4 study testing Immediate IUD insertion in people with Contraception, run by Oregon Health and Science University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Immediate IUD insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 578 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2007to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Desiring intrauterine contraception
- In general good health
- Willing and able to undergo informed consent
- Willing to comply with randomization and study follow-up schedule
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of New Mexico
Albuquerque, New Mexico
Emory University
Atlanta, Georgia
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania
About this study
Official title: Immediate Versus Delayed IUD Insertion Following Suction Aspiration Between 5 and 12 Weeks Gestation: a Randomized Trial
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.
- Conditions
- Contraception
- Being tested
- Immediate IUD insertion
- Keywords
- IUD, insertion timing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate IUD insertionProcedure or surgery
Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Immediate IUD insertion following suction aspiration between 5 and 12 weeks gestation Receives: Procedure: Immediate IUD insertion |
| 2 | No intervention | Delayed IUD insertion 2-6 weeks following suction aspiration between 5 and 12 weeks gestation |
What is being measured
The primary outcome is the main question the study is designed to answer.
IUD expulsion
Measured: 1, 3 and 6 months after insertion
Secondary outcomes (1)
IUD continuation
Measured: 1, 3 and 6 months after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Bednarek, Oregon Health and Science University
- Investigators
- Paula H Bednarek, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562276
- Sponsor's protocol ID
- OHSU FAMPLAN 2535
- Acronym
- PAIR
- Status last verified
- Sep 2012
- First submitted
- 21 Nov 2007
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25487172Bednarek 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.
PubMed 21651392
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Delayed IUD Insertion Following Suction Aspiration Between 5 and 12 Weeks Gestation: a Randomized Trial
- ClinicalTrials.gov ID
- NCT00562276
- Acronym / sponsor ID
- PAIR / OHSU FAMPLAN 2535
- Conditions
- Contraception
- Keywords
- IUD, insertion timing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Immediate IUD insertionImmediate IUD insertion following suction aspiration between 5 and 12 weeks gestation |
| 2 | No intervention | –Delayed IUD insertion 2-6 weeks following suction aspiration between 5 and 12 weeks gestation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Desiring intrauterine contraception
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate IUD insertionInsertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation | Procedure or surgery | 1 |
Primary outcome
IUD expulsion
Time frame: 1, 3 and 6 months after insertion
1 secondary outcome
IUD continuation
Time frame: 1, 3 and 6 months after insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
- Derived from this study: PubMed 25487172Bednarek 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.
- Derived from this study: PubMed 21651392Bednarek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula H Bednarek, MD principal investigator
Oregon Health and Science University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immediate IUD insertion in people with Contraception, run by Oregon Health and Science University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IUD expulsion (time frame: 1, 3 and 6 months after insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00562276, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2012.