Clinical trial: Immediate Versus Delayed Intrauterine Device (IUD) Insertion Following First Trimester Suction Aspiration Procedures (NCT00562276)

Eligibility criteria:
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
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 1