Pre-EclampsiaNCT03838887
Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia
An observational study of Pre-Eclampsia, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
Preeclampsia is a multisystem disorder that can cause considerable maternal and fetal morbidity and mortality. Late preeclampsia (with delivery >34 weeks) is more frequent and less serious than early preeclampsia (with delivery <34 weeks). Poor early placentation has been especially associated with early disease. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- ultrasound machine
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Jan 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All pregnant women will be examined for antenatal care in the outpatient clinic and fetal medicine unit of obstetrics and gynecology department then they will be divided into two groups control and high risk
Who may be able to join
- A. Control group: Pregnant women:
- Age between 18-35 years
- Parity: primigravidas and multiparas.
- Have no history of preeclampsia or eclampsia.
- Have no history of chronic hypertension.
- Not diabetic.
Show all 14Show fewer
- Not have antiphospholipid syndrome.
- Not have autoimmune disease such as SLE.
- High risk group: Pregnant women with:
- History of preeclampsia -Eclapmsia
- Chronic hypertension
- Diabetic
- Antiphospholipid syndrome.
- Autoimmune syndrome such as SLE.
Who cannot join
- • Smoking
- Dichorionic placentae
- Fetal anomaly
- Uterine fibroid at the site of placental implantation
- Subchorionic hematoma
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Research Centre
Cairo, 1234
SHERIF MOHAMMED ELSIRGANY, DOCTOR, +01223607191, SHERIFELSIRGANY@YAHOO.COM
About this study
- Preeclampsia is a multisystem disorder that can cause considerable maternal and fetal morbidity and mortality. Late preeclampsia (with delivery >34 weeks) is more frequent and less serious than early preeclampsia (with delivery <34 weeks). Poor early placentation has been especially associated with early disease. Early identification of women at risk of preeclampsia is currently a crucial aim of antenatal care since they may benefit from prophylactic treatment and increased surveillance.
Read the detailed description
- The introduction of three-dimensional (3D) ultrasound techniques, with the option of calculating placental volume and measuring vascular indices, has created an excellent opportunity to study early changes in the uteroplacental circulation space, which includes the maternal spiral arteries and the intervillous space. This technology may allow a more direct evaluation of the abnormal placentation process thought to herald the development of preeclampsia.
- The aim of this study was to assess the usefulness of placental volume and 3D vascular indices as reliable predictors of early preeclampsia in comparison to uterine artery Doppler
- Conditions
- Pre-Eclampsia
- Being tested
- ultrasound machine
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound machineDevice
Ultrasound machine with a vocal software
| Study group | Role | What they receive |
|---|---|---|
| control group | Pregnant women:
1. Age between 18-35 years
2. Parity: primigravidas and multiparas.
3. Have no history of preeclampsia or eclampsia.
4. Have no history of chronic hypertension.
5. Not diabetic.
6. Not have antiphospholipid syndrome.
7. Not have autoimmune disease such as SLE Receives: Device: ultrasound machine | |
| High risk group | Pregnant women with:
1. History of preeclampsia -Eclapmsia
2. Chronic hypertension
3. Diabetic
4. Antiphospholipid syndrome.
5. Autoimmune syndrome such as SLE. Receives: Device: ultrasound machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
placental vascular indices in prediction of preeclampsia
placental vascular indices in prediction of preeclampsia compared to uterine artery doppler in prediction of preeclampsia
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Jun 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Elsirgany, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838887
- Sponsor's protocol ID
- placental vascular indices
- Status last verified
- Aug 2021
- First submitted
- 3 Feb 2019
- Last updated
- 18 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia
- ClinicalTrials.gov ID
- NCT03838887
- Acronym / sponsor ID
- placental vascular indices
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 12 Feb 2019 (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.
- Preeclampsia is a multisystem disorder that can cause considerable maternal and fetal morbidity and mortality. Late preeclampsia (with delivery >34 weeks) is more frequent and less serious than early preeclampsia (with delivery <34 weeks). Poor early placentation has been especially associated with early disease. Early identification of women at risk of preeclampsia is currently a crucial aim of antenatal care since they may benefit from prophylactic treatment and increased surveillance.
Detailed description
- The introduction of three-dimensional (3D) ultrasound techniques, with the option of calculating placental volume and measuring vascular indices, has created an excellent opportunity to study early changes in the uteroplacental circulation space, which includes the maternal spiral arteries and the intervillous space. This technology may allow a more direct evaluation of the abnormal placentation process thought to herald the development of preeclampsia.
- The aim of this study was to assess the usefulness of placental volume and 3D vascular indices as reliable predictors of early preeclampsia in comparison to uterine artery Doppler
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Device: ultrasound machinePregnant women: 1. Age between 18-35 years 2. Parity: primigravidas and multiparas. 3. Have no history of preeclampsia or eclampsia. 4. Have no history of chronic hypertension. 5. Not diabetic. 6. Not have antiphospholipid syndrome. 7. Not have autoimmune disease such as SLE |
| High risk group | – | Device: ultrasound machinePregnant women with: 1. History of preeclampsia -Eclapmsia 2. Chronic hypertension 3. Diabetic 4. Antiphospholipid syndrome. 5. Autoimmune syndrome such as SLE. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All pregnant women will be examined for antenatal care in the outpatient clinic and fetal medicine unit of obstetrics and gynecology department then they will be divided into two groups control and high risk
Key inclusion criteria (14 listed)
- A. Control group: Pregnant women:
- High risk group: Pregnant women with:
- History of preeclampsia -Eclapmsia
- Chronic hypertension
- Diabetic
Key exclusion criteria (5 listed)
- • Smoking
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 |
|---|---|---|
| ultrasound machineUltrasound machine with a vocal software | Device | High risk group, control group |
Primary outcome
placental vascular indices in prediction of preeclampsia
Time frame: one year
placental vascular indices in prediction of preeclampsia compared to uterine artery doppler in prediction of preeclampsia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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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 Pre-Eclampsia, run by National Research Centre, Egypt 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 14 inclusion and 5 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 18 Aug 2021. 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 SHERIF MOHAMMED ELSIRGANY, DOCTOR (+201223607191, SHERIFELSIRGANY@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
placental vascular indices in prediction of preeclampsia (time frame: one year). 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 18 Aug 2021.