Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound

Septum; Uterus Clinical Trial

Official title:

Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792438
• Other study ID #: Hesham Mohamed Elnaggar
• Status: Completed
• Start date: May 27, 2017
• Est. completion date: November 25, 2018

Study information

• Verified date: January 2019
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to assess the relation between the vascularity of uterine septum and obstetric performance with Transvaginal 3D Power Doppler Ultrasound

Description:

Research hypothesis:

In women with uterine septum vascularity of the septum may affect obstetric performance.

Research question:

In women with uterine septum does vascularity of the septum affect obstetric outcome?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 25, 2018
• Est. primary completion date: November 25, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Patients with septate uterus diagnosed by office hysteroscopy

Exclusion Criteria:

• Women with previous uterine scar.

• Women with suspected or confirmed pregnancy.

• Women with active pelvic infection or old one.

• Women with abnormal uterine bleeding.

• Fibroids, adenomyosis or ovarian swelling.

Related Conditions & MeSH terms

• Septum; Uterus

Intervention

Diagnostic Test:
• Transvaginal 3D Power Doppler Ultrasound
Samsung H60 ultrasound machine with 4-9 MHz volume transducer using VOCAL system and Histogram Facility

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium	Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium and its relationship to either primary infertility or recurrent abortion	About 18 months