'Levonorgestrel IUD Insertion After D&E Procedure

NCT00475228 | Completed Phase 4 Results

• 1 other identifier: Pitt IRB PRO06040004
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraceptive Usage

Keywords

levonorgestrel IUD; IUD; dilation and evacuation; contraception

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment.

  To assess the six-month usage rate of the LNG-IUD when placed immediately after D\&E compared to 3-6 weeks later, as measured by the proportion of women with a LNG-IUD in place at six months after the D\&E. 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.

  6 months

Secondary Outcomes (2)

• To Examine the Number of Women Receiving the LNG-IUD in Each Group

  2 Months

• To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion

  6 months

Study Arms (2)

Arm I

EXPERIMENTAL

Levonorgestrel IUD will be inserted immediately after completion of D\&E

Drug: Levonorgestrel IUD

Arm 2

ACTIVE COMPARATOR

Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D\&E procedure)

Drug: Levonorgestrel IUD

Interventions

Levonorgestrel IUD DRUG

intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem

Also known as: Mirena

Arm 2; Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Center for Family Planning Research

Pittsburgh, Pennsylvania, 15215, United States

Location

MeSH Terms

Conditions

Contraception Behavior; Dilatation, Pathologic

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Heather Hohmann, MD
• Organization: University o Pittsburgh

hhohmann@mail.magee.edu

412-641-1441

Study Officials

• Heather Hohmann, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 21, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 9, 2017
• Results First Posted: May 9, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)