Clinical trial NCT00562276: Immediate Versus Delayed Intrauterine Device (IUD) Insertion Following First Trimester Suction Aspiration Procedures
Official title: Immediate Versus Delayed IUD Insertion Following Suction Aspiration Between 5 and 12 Weeks Gestation: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: IUD
insertion timing
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2007-11-22
Enrollment: 578
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: IUD expulsion
timeFrame: 1, 3 and 6 months after insertion
Secondary outcomes:
measure: IUD continuation
timeFrame: 1, 3 and 6 months after insertion
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
Study officials:
affiliation: Oregon Health and Science University
name: Paula H Bednarek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.