Phase 4 Completed N=88 Randomized Treatment

'Levonorgestrel IUD Insertion After D&E Procedure

Contraceptive Usage

Source: ClinicalTrials.gov NCT00475228 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcomePrimary: The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment. — 85.2; 62.9 percentage of participants — p=0.05

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment.	85.2; 62.9	0.05
SECONDARY To Examine the Number of Women Receiving the LNG-IUD in Each Group	20; 44	—
SECONDARY To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion	6.8; 5.0	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00475228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.