Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound
Sponsor
Ain Shams Maternity Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03792438
Collaborator
(none)
30
1
18
1.7
Study Details
Study Description
Brief Summary
This study aims to assess the relation between the vascularity of uterine septum and obstetric performance with Transvaginal 3D Power Doppler Ultrasound
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational
Actual Enrollment
:
30 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound
Actual Study Start Date
:
May 27, 2017
Actual Primary Completion Date
:
Nov 25, 2018
Actual Study Completion Date
:
Nov 25, 2018
Outcome Measures
Primary Outcome Measures
- Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium [About 18 months]
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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ain Shams University Maternity Hospital | Cairo | Egypt | 11357 |
Sponsors and Collaborators
- Ain Shams Maternity Hospital
Investigators
- Study Chair: Mohamed I Amer, MD, Professor
- Study Director: Nashwa E Hassan, MD, Assistant Professor
- Study Director: Mortada E Ahmed, MD, Lecturer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hesham Mohamed Mohamed Elnaggar,
Principal Investigator,
Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier:
NCT03792438
Other Study ID Numbers:
- Hesham Mohamed Elnaggar
First Posted:
Jan 3, 2019
Last Update Posted:
Jan 3, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No