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

Oregon Health & Science University (OHSU)

Status and phase

Completed

Phase 4

Conditions

Contraception

Treatments

Procedure: Immediate IUD insertion

Study type

Interventional

Funder types

Other

Identifiers

NCT00562276

OHSU FAMPLAN 2535

Details and patient eligibility

About

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.

Enrollment

578 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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