IUD Placement Without Sounding

University of California (UC) Davis

Status: Completed

Conditions: IUD; Complications; IUD Insertion Complication; IUD

Treatments: Procedure: Sound sparing levonorgestrel 52 mg IUD placement

Study type: Interventional

Funder types: Other

Identifiers

NCT05700812

1952890

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

IUD insertion study in three phases

Experimental group

Description:

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.

Treatment:

Procedure: Sound sparing levonorgestrel 52 mg IUD placement