Clinical trial NCT05700812: IUD Placement Without Sounding
Official title: Feasibility Study of IUD Placement Without Sounding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD
IUD Insertion Complication
IUD; Complications
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Three phase study. Phase one will only include gathering baseline data without intervention. Phases two and three each include a different intervention.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Successful placement, defined by ultrasound confirmation, of a levonorgestrel 52 mg IUD placement without uterine sounding.
timeFrame: Ultrasound completed at end of IUD placement procedure to determine if successfully placed in the correct location.
Secondary outcomes:
measure: Total time of IUD placement measured in minutes
timeFrame: Measured once on day of IUD placement
measure: Participant-reported maximum pain during IUD placement measured with a 100-mm visual analog scale
timeFrame: Measured once on day of IUD placement
measure: Participant-reported pain 5-minutes post IUD placement, meaured with a 100-mm visual analog scale
timeFrame: Measured once on day of IUD placement
measure: Provider assessment of ease of placement defined as an easy, moderate or difficult placement.
timeFrame: Measured once on day of IUD placement
measure: IUD expulsion and perforation rate during first three months after placement with sound-sparing technique
timeFrame: Measured at time of IUD insertion and three month clinic follow up three months after IUD placement
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
References: