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

Phase 4

Completed

• Conditions: Contraception
• Interventions: Procedure: Immediate IUD insertion

• Registration Number: NCT00562276
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-22
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-12
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 578

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Immediate IUD insertion	Immediate IUD insertion following suction aspiration between 5 and 12 weeks gestation

Primary Outcome Measures

Name	Time	Method
IUD expulsion	1, 3 and 6 months after insertion

Secondary Outcome Measures

Name	Time	Method
IUD continuation	1, 3 and 6 months after insertion

Trial Locations

Locations (3)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Pittsburgh School of Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States