IUD Placement Without Sounding

Last updated: August 5, 2024
Sponsor: University of California, Davis
Overall Status: Completed

Phase

N/A

Condition

Intrauterine Device

Treatment

Sound sparing levonorgestrel 52 mg IUD placement

Clinical Study ID

NCT05700812
1952890
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to determine the feasibility of a uterine sound sparing technique for levonorgestrel 52 mg intrauterine device (IUD) placement. This study will be conducted in three phases. In phase one, the IUD will be placed in standard fashion with a uterine sound to obtain baseline data. Phase two and three are interventional phases that will investigate IUD placement without the use of a uterine sound. In phase two, the IUD will be placed without the use of a uterine sound, but under abdominal ultrasound guidance. In phase three, the IUD will be placed without the use of a uterine sound and without ultrasound guidance. An ultrasound exam will be completed at the end of phase two and three to determine if the IUD was successful placed. To answer the secondary objectives, for all study phases the investigators will measure the procedure time, the participant-reported maximum pain during and 5-minutes post placement and the provider assessment of ease of placement. To determine the exploratory objective of IUD expulsion and perforation rate for a uterine sound sparing IUD placement technique, participants in phases two and three will complete a 30-day phone follow up and 90-day in clinic follow up to evaluate for IUD expulsion or perforation. The investigators hypothesize that the levonorgestrel 52 mg IUD can successfully be inserted without uterine sounding.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • Patients undergoing a levonorgestrel 52 mg IUD placement for contraception at a UCDavis outpatient clinic, who have signed consent for placement and are candidatesfor levonorgestrel 52 mg IUD placement based on the clinical judgement of their UCDavis Ob-Gyn provider.

Exclusion

Exclusion Criteria:

  • Women with prior failed IUD placement

  • Women with known uterine anomalies or uterine fibroids that distort the uterinecavity

  • Women with known cervical stenosis

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Sound sparing levonorgestrel 52 mg IUD placement
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
July 31, 2024

Connect with a study center

  • University of California Davis

    Sacramento, California 95817
    United States

    Site Not Available

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