'Levonorgestrel IUD Insertion After D&E Procedure
Condition: Contraceptive Usage
Intervention: Levonorgestrel IUD
Intervention description: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem
Intervention MeSH terms: Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: levonorgestrel IUD; IUD; dilation and evacuation; contraception

Summary:

      This study is a randomized controlled trial of insertion of the levonorgestrel-releasing
      intrauterine device (LNG-IUD) immediately following dilation & evacuation (D&E) compared to
      delayed insertion 3-6 weeks post-D&E. Eighty-eight women undergoing D&E between 15 0/7 and 23
      6/7 weeks gestation will be enrolled at Magee-Womens Hospital, Pittsburgh, PA. The primary
      outcome is LNG-IUD usage six months following enrollment. We hypothesize that more women
      receiving immediate insertion will be using the LNG-IUD 6 months after the D&E procedure than
      women receiving delayed insertion. Secondary outcomes include the proportion receiving an
      IUD, continuation rate, complication rates, subject satisfaction, and quality of life. The
      utility of ultrasonography in predicting expulsion will also be examined. Anticipated
      problems include poor subject follow-up and coordinating the intra-operative study
      procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Gestational age from 15 weeks 0 days to 23 weeks 6 days at enrollment (time of D&E),
             confirmed by ultrasound

          2. Has already consented to a D&E

          3. Desires to use the LNG-IUD (Mirena) for contraception for 12 months or more

          4. Willing and able to sign an informed consent

          5. Willing to comply with the study protocol

          6. Age greater than or equal to 18 years

          7. Primary residency in Allegheny, Beaver, Washington, Westmoreland, Butler, Armstrong,
             Indiana, Fayette, Greene, or Lawrence counties of Pennsylvania

        Exclusion Criteria:

          1. Allergy to either polyethylene or levonorgestrel

          2. Urgent need for termination of pregnancy (active bleeding or infection)

          3. Exposure to or treatment for gonorrhea or Chlamydia within the past 90 days

          4. Diagnosis of pelvic inflammatory disease within the past year

          5. Presence of one or more leiomyomata greater than 3 centimeters in diameter

          6. Uterine anomaly (other than a repaired septate uterus)

          7. Current participation in any other intervention trial

        Post-Enrollment Pre-Randomization Exclusion criteria (to be assessed at the completion of
        the D&E. These criteria will be used to define a group not eligible for immediate
        insertion. Since these complications contraindicate immediate insertion, the issue of
        whether immediate and delayed insertion is preferable is no longer in question.)

          1. Uterine perforation

          2. Hemorrhage as defined by one of the following: (1) need for transfusion; (2) estimated
             blood loss greater than 500 cc; (3) intrauterine placement of a Foley catheter; or (4)
             the use of 3 or more doses of uterotonic medications

          3. Evidence of infection at the time of the D&E, including fever (temperature ≥ 38°C) or
             pus at the cervical os

          4. Subject no longer desires a LNG-IUD