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Intrauterine Device
Soundless IUD Placement Method
N/A
Recruiting
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at time of iud insertion and three month clinic follow up three months after iud placement
Awards & highlights
Study Summary
This trial will test if a type of IUD can be placed in the uterus without using a sound and ultrasound guidance, with follow-up to check for expulsion or perforation.
Who is the study for?
This trial is for women over 18 who are getting a levonorgestrel 52 mg IUD for birth control at a UC Davis clinic and have their doctor's approval. It's not for those with past IUD placement failures, uterine abnormalities, fibroids that change the shape of the uterus, or tightness in the cervix.Check my eligibility
What is being tested?
The study tests if doctors can place an IUD without using a 'uterine sound,' which measures the uterus before insertion. Participants will first get an IUD with sounding (baseline), then without it but with ultrasound guidance, and finally without either sounding or ultrasound.See study design
What are the potential side effects?
Potential side effects may include discomfort during and after IUD placement, possible complications like expulsion where the IUD comes out unintentionally or perforation where it could puncture the uterine wall.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at time of iud insertion and three month clinic follow up three months after iud placement
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at time of iud insertion and three month clinic follow up three months after iud placement
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful placement, defined by ultrasound confirmation, of a levonorgestrel 52 mg IUD placement without uterine sounding.
Secondary outcome measures
IUD expulsion and perforation rate during first three months after placement with sound-sparing technique
Participant-reported maximum pain during IUD placement measured with a 100-mm visual analog scale
Participant-reported pain 5-minutes post IUD placement, meaured with a 100-mm visual analog scale
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: IUD insertion study in three phasesExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,429 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an unsuccessful attempt at placing an IUD before.I have uterine fibroids or anomalies that change the shape of my uterus.I have been diagnosed with cervical stenosis.I am 18 years old or older.I am getting a 52 mg levonorgestrel IUD for birth control at a UC Davis clinic.
Research Study Groups:
This trial has the following groups:- Group 1: IUD insertion study in three phases
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the projected enrollment size for this clinical trial?
"Affirmative. The records available on clinicaltrials.gov shows that this experiment, initially posted out on February 1st 2023, is currently in search of participants. A total of 90 patients need to be recruited from a single medical centre."
Answered by AI
Is this research investigation currently enrolling participants?
"According to clinicaltrials.gov, the study is now actively seeking participants with an initial posting date of February 1st 2023 and a final update on June 13th 2023."
Answered by AI
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