Skip to main content
OpenTrials
Completed

NCT Number: NCT00562276

Immediate Versus Delayed Intrauterine Device (IUD) Insertion Following First Trimester Suction Aspiration Procedures

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Emory University, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate IUD insertion

Procedure

Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation

Primary outcomes

  1. IUD expulsion

    Time frame: 1, 3 and 6 months after insertion

Secondary outcomes

  1. IUD continuation

    Time frame: 1, 3 and 6 months after insertion

Interested in participating?

Completed

Looking for future studies?

Notify Me

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Immediate Versus Delayed IUD Insertion Following Suction Aspiration Between 5 and 12 Weeks Gestation: a Randomized Trial

Acronym: PAIR

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 22, 2007
Registry last updated
Sep 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.