Pre-EclampsiaNCT04126122
Maternal and Neonatal Outcome in Severe Preeclampsia
An observational study of Pre-Eclampsia, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
In normal pregnancy the spiral arteries in the placental bed are invaded by trophoblast, which becomes incorporated into the vessel wall and replaces the endothelium, muscular layer and neural tissue Read more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Ultrasonography to assess fetus and mother
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2019to 1 Feb 2020
- 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 20 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant ladies with preeclampsia
Who may be able to join
- • All women with severe preeclampsia
Who cannot join
- • History of epilepsy.
- Patients with chronic hypertension.
- Patients with renal disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aljazeera( Al Gazeera) hospital
Giza
Mahmoud Alalfy, PhD, +201002611058 ext. +2, mahmoudalalfy@ymail.com
About this study
Official title: Maternal and Neonatal Outcome in Severe Preeclamptic Patients
In normal pregnancy the spiral arteries in the placental bed are invaded by trophoblast, which becomes incorporated into the vessel wall and replaces the endothelium, muscular layer and neural tissue
Read the detailed description
Preeclampsia is considered severe if one or more of the following:
- Blood pressure of 160mmHg systolic or high or 110mmHg diastolic or high on two occasions at least 6 hours a part while the patient on bed rest.
- Proteinuria of 0.3gm. or high in 24 hours urine specimen or +1 or great on two random urine samples collected at least 4 hours apart.
- Oliguria of less than 500ml in 24 hours.
- Cerebral or visual disturbance.
- Pulmonary edema or cyanosis.
- Conditions
- Pre-Eclampsia
- Being tested
- Ultrasonography to assess fetus and mother
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography to assess fetus and motherDiagnostic test
to assess fetal growth and maternal outcome
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who will develop adverse outcome
The women with preeclampsia who will develop eclampsia or pulmonaryb edema
Measured: within 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start10 Feb 2019
- Primary completion10 Jan 2020 (estimated)
- Study completion1 Feb 2020 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126122
- Sponsor's protocol ID
- Preeclampsia
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Neonatal Outcome in Severe Preeclamptic Patients
- ClinicalTrials.gov ID
- NCT04126122
- Acronym / sponsor ID
- Preeclampsia
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 10 Jan 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 15 Oct 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.
In normal pregnancy the spiral arteries in the placental bed are invaded by trophoblast, which becomes incorporated into the vessel wall and replaces the endothelium, muscular layer and neural tissue
Detailed description
Preeclampsia is considered severe if one or more of the following:
- Blood pressure of 160mmHg systolic or high or 110mmHg diastolic or high on two occasions at least 6 hours a part while the patient on bed rest.
- Proteinuria of 0.3gm. or high in 24 hours urine specimen or +1 or great on two random urine samples collected at least 4 hours apart.
- Oliguria of less than 500ml in 24 hours.
- Cerebral or visual disturbance.
- Pulmonary edema or cyanosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant ladies with preeclampsia
Key inclusion criteria (1 listed)
- • All women with severe preeclampsia
Key exclusion criteria (3 listed)
- • History of epilepsy.
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 |
|---|---|---|
| Ultrasonography to assess fetus and motherto assess fetal growth and maternal outcome | Diagnostic test | – |
Primary outcome
The number of women who will develop adverse outcome
Time frame: within 5 months
The women with preeclampsia who will develop eclampsia or pulmonaryb edema
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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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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Severe Preeclampsia
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 Aljazeera Hospital 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 3 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 Oct 2019. 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 Mahmoud Alalfy, PhD (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of women who will develop adverse outcome (time frame: within 5 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 Oct 2019.