Pregnancy Induced HypertensionNCT05330949
Optical Coherence Tomography Angiography Compared to Maternal Doppler in Screening for Hypertension in Pregnancy
An observational study of Pregnancy Induced Hypertension, run by Minia University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 to 45 years, women only
- Conditions the study is for
- Pregnancy Induced Hypertension
- What is being tested?
- Optical coherence Tomography Angiography, Uterine artry doppler
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 45 years
- Women only
- Adult
Study population: two groups according to the risk of developing hypertension during pregnancy
Who may be able to join
- Pregnant women in the first and second trimesters
Who cannot join
- pregnant females with associated systemic vascular disease as diabetes, SLE
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia University
Minya, Minia Governorate, 61111
Mohamed EK Esmail, MD, 00201006185533, mohamed.ismaeel@mu.edu.eg
Mohamed EK Esmail, MD
About this study
Official title: Retinal Microvascular Changes by Optical Coherence Tomography Angiography Compared to Maternal Uterine Artry Doppler in Screening for Hypertensive Disorders in High-risk Pregnancies
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
- Conditions
- Pregnancy Induced Hypertension
- Being tested
- Optical coherence Tomography Angiography, Uterine artry doppler
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| case group | Not described Receives: Diagnostic Test: Optical coherence Tomography Angiography, Uterine artry doppler | |
| control | Not described Receives: Diagnostic Test: Optical coherence Tomography Angiography, Uterine artry doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
validity and sensitivity of OCT angiography
sensitivity of OCTA in comparison to doppler in prediction of pregnancy related hypertension
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Apr 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Induced HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Esmail Khalil Esmail, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330949
- Sponsor's protocol ID
- 294-2022
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Microvascular Changes by Optical Coherence Tomography Angiography Compared to Maternal Uterine Artry Doppler in Screening for Hypertensive Disorders in High-risk Pregnancies
- ClinicalTrials.gov ID
- NCT05330949
- Acronym / sponsor ID
- 294-2022
- Conditions
- Pregnancy Induced Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: Optical coherence Tomography Angiography, Uterine artry doppler |
| control | – | Diagnostic Test: Optical coherence Tomography Angiography, Uterine artry doppler |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- two groups according to the risk of developing hypertension during pregnancy
Key inclusion criteria (1 listed)
- Pregnant women in the first and second trimesters
Key exclusion criteria (1 listed)
- pregnant females with associated systemic vascular disease as diabetes, SLE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence Tomography Angiography, Uterine artry dopplervascular changes in retina by OCT angiography and uterine artry doppler in the first and second trimesters | Diagnostic test | case group, control |
Primary outcome
validity and sensitivity of OCT angiography
Time frame: 6 months
sensitivity of OCTA in comparison to doppler in prediction of pregnancy related hypertension
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Induced Hypertension, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed EK Esmail, MD (00201006185533, mohamed.ismaeel@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity and sensitivity of OCT angiography (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.