Creating a decision aid tool for women with small, asymptomatic uterine leiomyomas
Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
This study is trying to create a helpful tool for women with small, non-problematic uterine fibroids to make better decisions about their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Shenzhen Maternity & Child Healthcare Hospital Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT05500118 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a decision aid tool for women diagnosed with asymptomatic small leiomyomas, focusing on improving clinical decision-making. A committee of designers, doctors, nurses, and patients will collaborate to identify factors influencing these decisions based on clinical guidelines and evidence-based medicine. The study will involve prospective trials to assess whether the decision aid tool enhances patients' decision-making efficacy and improves their reported outcomes. Participants will be women aged 18-55 with specific criteria regarding their leiomyoma diagnosis.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-55 with asymptomatic small leiomyomas diagnosed via imaging.
Not a fit: Patients with symptomatic leiomyomas, those who have undergone myomectomy, or have other significant gynecological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could empower patients to make more informed decisions regarding their treatment options for asymptomatic leiomyomas.
How similar studies have performed: While similar decision aid tools have been explored in other contexts, this specific approach for asymptomatic leiomyomas is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of leiomyoma: patients with leiomyoma diagnosed by imaging examinations (ultrasound and MRI) have no clinical symptoms; 2. Female with age in 18-55 years old; 3. The maximum diameter of a single leiomyoma is less than 5m, and the number does not exceed 10 by MRI; 4. No contraindications for sedation and analgesia; 5. Patients and their families agree to join this study, and can follow up on time. Exclusion Criteria: 1. History of myomectomy, including transabdominal, laparoscopic, hysteroscopy, etc.; 2. History of connective tissue diseases or radiotherapy, especially abdominal radiotherapy; 3. With pregnancy, acute inflammation of the reproductive tract, or other gynecological benign and malignant diseases such as endometriosis and ovarian tumors; 4. The maximum diameter of leiomyoma is greater than or equal to 5cm; 5. Suspected malignant tumor, such as sarcoma; 6. Those with language communication barriers and unable to cooperate with sedative and analgesic programs; 7. Abdominal scarring, when diagnosed by ultrasound transabdominal scan, has obvious sound attenuation (more than 10mm range).
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Maternal and Child Health Hospital — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yu Dai, Associate Professor
- Email: daiyu829@163.com
- Phone: 13828718985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.