Creating a decision aid tool for women with small, asymptomatic uterine leiomyomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shenzhen Maternal and Child Health Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yu Dai, Associate Professor
• Email: daiyu829@163.com
• Phone: 13828718985

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.