Using ultrasound to guide endometrial biopsies for post-menopausal bleeding

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 trial investigates the effectiveness of using transabdominal ultrasound guidance during Pipelle® endometrial biopsies for women experiencing post-menopausal bleeding. The aim is to improve the success rate of obtaining adequate tissue samples for laboratory assessment, thereby reducing the need for more invasive procedures. Participants will be randomly assigned to receive either ultrasound-guided or standard biopsies. The study focuses on women with thickened endometrial linings who require biopsies to rule out endometrial cancer or hyperplasia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All patients with post-menopausal bleeding who require an endometrial biopsy.

Further details:

* Post-menopausal bleeding is defined as bleeding one year after a woman's last menstrual period or bleeding six months after starting continuous combined hormone replacement therapy.
* There is no upper age limit, however all patients must be 18 or above.

Strict ultrasound criteria will be followed:

* Endometrium ≥5mm: this is the current cut off used by Imperial College Healthcare NHS Trust for a biopsy to be indicated in the context of post-menopausal bleeding.
* Smooth, homogenous endometrium with a clearly defined border.

Exclusion Criteria:

* Focal endometrial pathology (including but not limited to endometrial polyps, type 0-2 fibroids, uterine septa and other uterine structural abnormalities).
* Suspicion of non-benign myometrial pathology.
* History of endometrial cancer or endometrial hyperplasia.
* History of cervical cancer.
* Virgo intacta.
* Inability to tolerate vaginal examination.
* Inability to consent.
* The denial or withdrawal of informed written consent.

Where it's running

• Queen Charlotte's and Chelsea Hospital, Imperial College Healthcare Trust
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Joseph Yazbek, MD — Imperial College Healthcare Trust
• Study coordinator: Joseph Yazbek, MD
• Email: joseph.yazbek@nhs.net
• Phone: 02033133570

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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.