Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
completion around

Description

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.

Official Title

Feasibility Study of IUD Placement Without Sounding

Keywords

IUD, IUD Insertion Complication, IUD; Complications, Levonorgestrel, Sound sparing levonorgestrel 52 mg IUD placement

Eligibility

You can join if…

Open to females ages 18 years and up

  • Age ≥18 years
  • Patients undergoing a levonorgestrel 52 mg IUD placement for contraception at a UC Davis outpatient clinic, who have signed consent for placement and are candidates for levonorgestrel 52 mg IUD placement based on the clinical judgement of their UC Davis Ob-Gyn provider.

You CAN'T join if...

Location

  • University of California Davis accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT05700812
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated