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.

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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

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

IUD expulsion

Time frame: 1, 3 and 6 months after insertion

Secondary outcomes

IUD continuation

Time frame: 1, 3 and 6 months after insertion

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.

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

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