NCT05330949

Brief Summary

Pregnancy related hypertension is one of the most prevalent obstetric complications. The aim of the study is to evaluate the validity and sensitivity of OCT angiography in prediction of pregnancy induced hypertensive disorders in comparison to maternal doppler in the first and second trimesters of pregnancy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

April 8, 2022

Last Update Submit

April 8, 2022

Conditions

Pregnancy Induced Hypertension

Outcome Measures

Primary Outcomes (1)

  • validity and sensitivity of OCT angiography

    sensitivity of OCTA in comparison to doppler in prediction of pregnancy related hypertension

    6 months

Study Arms (2)

case group

Diagnostic Test: Optical coherence Tomography Angiography, Uterine artry doppler

control

Diagnostic Test: Optical coherence Tomography Angiography, Uterine artry doppler

Interventions

Optical coherence Tomography Angiography, Uterine artry dopplerDIAGNOSTIC_TEST

vascular changes in retina by OCT angiography and uterine artry doppler in the first and second trimesters

case groupcontrol

Eligibility Criteria

Age22 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant females
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

two groups according to the risk of developing hypertension during pregnancy

You may qualify if:

  • Pregnant women in the first and second trimesters

You may not qualify if:

  • pregnant females with associated systemic vascular disease as diabetes, SLE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, Minia Governorate, 61111, Egypt

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Mohamed EK Esmail, MD

CONTACT

00201006185533mohamed.ismaeel@mu.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Ophthalmology

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 15, 2022

Study Start

April 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations

EG(1)