IUD Placement Without Sounding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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IUD IUD Insertion Complication IUD; Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sound sparing levonorgestrel 52 mg IUD placement

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes