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

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

Study Overview

• Status: Completed
• Conditions: Septum; Uterus
• Intervention / Treatment: Diagnostic test: Transvaginal 3D Power Doppler Ultrasound

Detailed 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?

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11357
    • Ain Shams University Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary infertility or recurrent abortion attending to Early Cancer Detection Unit at Ain Shams Maternity Hospital

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Director: Nashwa E Hassan, MD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2017
• Primary Completion (Actual): November 25, 2018
• Study Completion (Actual): November 25, 2018

Study Registration Dates

• First Submitted: December 26, 2018
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Hesham Mohamed Elnaggar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No