Phase 4
N=88
'Levonorgestrel IUD Insertion After D&E Procedure
Contraceptive Usage
Bottom Line
View on ClinicalTrials.gov: NCT00475228 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment. — 85.2; 62.9 percentage of participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levonorgestrel IUD (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pittsburgh
- Primary completion
- Nov 2009
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 | — |
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
- 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
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.