3D ultrasound versus hysteroscopy for perimenopausal bleeding
Three Dimensional Ultrasonography Versus Hysteroscopy for the Evaluation of Patients With Perimenopausal Bleeding
This compares 3D ultrasound and hysteroscopy to see which better finds the cause of abnormal uterine bleeding in women aged 40–55 during the perimenopausal period.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 40 Years to 55 Years |
| Sex | Female |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Trial ID | NCT07309692 on ClinicalTrials.gov |
What this trial studies
Women aged 40–55 with at least three months of abnormal uterine bleeding will undergo evaluation using three-dimensional transvaginal ultrasonography and hysteroscopy. Investigators will compare the imaging and procedural findings to determine how well 3D ultrasound detects intrauterine causes of bleeding relative to hysteroscopy. The protocol excludes postmenopausal women, those with systemic causes of bleeding, current hormonal therapy or intrauterine devices, pregnancy, or contraindications to hysteroscopy. The study is conducted at Sohag University and uses the two modalities to directly compare diagnostic findings in the same clinical population.
Who should consider this trial
Good fit: Women aged 40–55 with abnormal uterine bleeding (menorrhagia or metrorrhagia) lasting more than three months, without ovarian lesions or local vaginal/cervical causes, and not using hormonal therapy or an IUD.
Not a fit: Women who are postmenopausal, pregnant, have systemic conditions causing bleeding (such as diabetes, hypertension, or chronic liver disease), are on hormonal therapy or using an IUD, or have contraindications to hysteroscopy (for example cervical stenosis) are excluded and unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, this could allow more cases to be diagnosed using a less invasive and quicker 3D ultrasound exam, reducing the need for invasive hysteroscopy in some patients.
How similar studies have performed: Previous work shows transvaginal and 3D ultrasound can detect many intrauterine abnormalities, but hysteroscopy remains the diagnostic reference standard.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Any pattern of abnormal uterine bleeding as menorrhagia or metrorrhagia for more than 3 months at age between 40 and 55 years , and no ovarian lesion or local cause of bleeding as vaginal or cervical ulcer Exclusion Criteria: * • Women with postmenopausal bleeding. * Systemic causes of perimenopausal bleeding DM Hypertension or chronic liver disease. * Women on hormonal therapy or using any contraception as IUD. * Women have contraindication for hysteroscopy as cervical stenosis or pregnancy.
Where this trial is running
Sohag
- Sohag University — Sohag, Egypt (Recruiting)
Study contacts
- Study coordinator: ahmed abdelrahem fattouh, resident of Obstetrics and Gyn
- Email: ahmedalatoon04@gmail.com
- Phone: 00201146329946
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.