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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Immediate 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate IUD insertion | Procedure | Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation |
|
| Measure | Description | Time Frame |
|---|---|---|
| IUD expulsion | 1, 3 and 6 months after insertion |
| Measure | Description | Time Frame |
|---|---|---|
| IUD continuation | 1, 3 and 6 months after insertion |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Paula H Bednarek, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | United States | |||
| University of New Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25487172 | Derived | 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. | |
| 21651392 | Derived |
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| Albuquerque |
| New Mexico |
| United States |
| University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania | United States |
| Bednarek 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. |