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

Contraception Clinical Trial

— PAIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562276
• Other study ID #: OHSU FAMPLAN 2535
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2007
• Last updated: September 12, 2012
• Start date: May 2007
• Est. completion date: June 2009

Study information

• Verified date: September 2012
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Procedure:
• Immediate IUD insertion
Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IUD expulsion		1, 3 and 6 months after insertion	No
Secondary	IUD continuation		1, 3 and 6 months after insertion	No