IUD Placement Without Sounding

NCT05700812 | Completed

• 1 other identifier: 1952890
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IUD; IUD Insertion Complication; IUD; Complications

Outcome Measures

Primary Outcomes (1)

• Successful placement, defined by ultrasound confirmation, of a levonorgestrel 52 mg IUD placement without uterine sounding.

  Successful placement without a uterine sound defined as ultrasound confirmation of IUD in the uterine cavity following placement. Outcomes will be compared between experimental phases two and three.

  Ultrasound completed at end of IUD placement procedure to determine if successfully placed in the correct location.

Secondary Outcomes (5)

• Total time of IUD placement measured in minutes

  Measured once on day of IUD placement

• Participant-reported maximum pain during IUD placement measured with a 100-mm visual analog scale

  Measured once on day of IUD placement

• Participant-reported pain 5-minutes post IUD placement, meaured with a 100-mm visual analog scale

  Measured once on day of IUD placement

• Provider assessment of ease of placement defined as an easy, moderate or difficult placement.

  Measured once on day of IUD placement

• IUD expulsion and perforation rate during first three months after placement with sound-sparing technique

  Measured at time of IUD insertion and three month clinic follow up three months after IUD placement

Study Arms (1)

IUD insertion study in three phases

EXPERIMENTAL

In phase one, the IUD will be placed in standard fashion with a uterine sound to obtain baseline data. In phase two, the IUD will be placed without the use of a uterine sound and under abdominal ultrasound guidance. In phase three, the IUD will be placed without the use of a uterine sound and without ultrasound guidance.

Procedure: Sound sparing levonorgestrel 52 mg IUD placement

Interventions

Sound sparing levonorgestrel 52 mg IUD placement PROCEDURE

In phase one, the IUD will be placed in a standard fashion with the use of a uterine sound to obtain baseline data. In the experimental phases of the study (phase 2 and 3) the levonorgestrel 52 mg IUD will be placed without the use of a uterine sound. In phase 2 the IUD will be placed under abdominal ultrasound guidance. In phase 3 the IUD will be placed without abdominal ultrasound guidance.

IUD insertion study in three phases

Eligibility Criteria

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

You may qualify if:

• 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 may not qualify if:

• Women with prior failed IUD placement
• Women with known uterine anomalies or uterine fibroids that distort the uterine cavity
• Women with known cervical stenosis

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three phase study. Phase one will only include gathering baseline data without intervention. Phases two and three each include a different intervention.

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 26, 2023
• Study Start: February 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 7, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)