'Levonorgestrel IUD Insertion After D&E Procedure

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Levonorgestrel

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