'Levonorgestrel IUD Insertion After D&E Procedure

Completed · Phase 4

Conditions studied: Contraceptive Usage

In brief

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.

Key facts

Study ID

NCT00475228

Run by

University of Pittsburgh

People needed

93

Starts

2007-03-01

Expected to finish

2009-11-01

Last updated by the study team

2017-05-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Gestational age from 15 weeks 0 days to 23 weeks 6 days at enrollment (time of D\&E), confirmed by ultrasound
• Has already consented to a D\&E
• Desires to use the LNG-IUD (Mirena) for contraception for 12 months or more
• Willing and able to sign an informed consent
• Willing to comply with the study protocol
• Age greater than or equal to 18 years
• Primary residency in Allegheny, Beaver, Washington, Westmoreland, Butler, Armstrong, Indiana, Fayette, Greene, or Lawrence counties of Pennsylvania

You may not qualify if…

• Allergy to either polyethylene or levonorgestrel
• Urgent need for termination of pregnancy (active bleeding or infection)
• Exposure to or treatment for gonorrhea or Chlamydia within the past 90 days
• Diagnosis of pelvic inflammatory disease within the past year
• Presence of one or more leiomyomata greater than 3 centimeters in diameter
• Uterine anomaly (other than a repaired septate uterus)
• 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.)
• Uterine perforation
• 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
• Evidence of infection at the time of the D\&E, including fever (temperature ≥ 38°C) or pus at the cervical os
• Subject no longer desires a LNG-IUD

Where it is running

• University of Pittsburgh Center for Family Planning Research — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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