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

Oregon Health and Science University3 sites in 1 country578 target enrollmentMay 2007

ConditionsContraception

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Contraception
Sponsor: Oregon Health and Science University
Enrollment: 578
Locations: 3
Primary Endpoint: IUD expulsion
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

the expulsion rates measured at 1, 3 and 6 months will be clinically equivalent with immediate insertion compared with delayed insertion,
satisfaction and tolerance of side effects will be higher with immediate IUD insertion compared with delayed insertion, and
overall IUD use/continuation rates measured at 1, 3 and 6 months will be higher with immediate IUD insertion compared with delayed insertion.

Registry

clinicaltrials.gov

Start Date

May 2007

End Date

June 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Oregon Health and Science University

Responsible Party

Principal Investigator

Paula Bednarek

Assistant Professor SM.OB/GYN Generalist Division

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

•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