IUD Placement Without Sounding

Feasibility Study of IUD Placement Without Sounding

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.

Study Overview

• Status: Completed
• Conditions: IUD Insertion Complication; IUD; IUD; Complications
• Intervention / Treatment: Procedure: Sound sparing levonorgestrel 52 mg IUD placement

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: IUD insertion study in three phases; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total time of IUD placement measured in minutes	Time measured from the start of the IUD inserter touching the cervix to the removal of the IUD inserter from the cervix in each of the three phases of the study. Outcomes will be compared for each of the three phases.	Measured once on day of IUD placement
Participant-reported maximum pain during IUD placement measured with a 100-mm visual analog scale	Participants will be handed a 100-mm visual analog scale and asked to mark their pain level. The assessment will be performed immediately following removal of IUD inserter and before the IUD thread is cut. Outcomes will be compared for each of the three phases.	Measured once on day of IUD placement
Participant-reported pain 5-minutes post IUD placement, meaured with a 100-mm visual analog scale	Participants will be handed a 100-mm visual analog scale and asked to mark their pain level. The assessment will be performed five minutes following removal of the speculum at the end of IUD placement procedure. Outcomes will be compared for each of the three phases.	Measured once on day of IUD placement
Provider assessment of ease of placement defined as an easy, moderate or difficult placement.	Providers placing the IUD will be asked to rate their assessment of the the ease of the IUD placement procedure as easy, moderate or difficult after completing IUD placement procedure. Outcomes will be compared for each of the three phases.	Measured once on day of IUD placement
IUD expulsion and perforation rate during first three months after placement with sound-sparing technique	An ultrasound exam will be completed on the day of the IUD placement to determine if the IUD is present in the uterine cavity and not perforated outside of the uterine cavity or expelled out of the uterine cavity. Outcomes will be reported for participants in phases two and three.	Measured at time of IUD insertion and three month clinic follow up three months after IUD placement

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: 1952890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No