Pre-EclampsiaNCT04367519
Optic Nerve Sheath Diameter for Volume Status Prediction in Severe Preeclampsia
An observational study of Pre-Eclampsia, run by Zagazig University at 1 site in Egypt.
Trial summary
A quick, non-invasive, bedside test to assess fluid status of patients with severe preeclampsia would be very helpful to ICU clinicians severe preeclampsia is associated with an increase in extravascular lung water (EVLW), which can be identified by lung ultrasound before appearance of clinical signs of pulmonary… Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Ultrasound measurement of Optic nerve sheath diameter
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 15 Apr 2020
- How long will I take part?
- 2 Days
- 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 21 to 45 years
- Women only
- Adult
Study population: Singleton Pregnant female complicated with severe preeclampsia. severe preeclampsia was determined by the presence of one or more of the following features using the American College of Obstetricians and Gynecologists severe features : * Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg on two occasions at least 4 hours apart * Thrombocytopenia (platelet count less than 100,000/L) * Impaired liver function indicated by elevated liver enzymes (to twice the upper limit normal concentration), and severe persistent right upper quadrant or epigastric pain not responding to medications and not explained by another diagnosis. * Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or doubling of the serum creatinine concentration in the absence of other renal disease) * Pulmonary edema * New-onset headache unresponsive to medications and not accounted for by alternative diagnoses * Visual disturbances
Who may be able to join
- Patient acceptance.
- Singleton Pregnant female complicated with severe preeclampsia
- Age 18-40 years old.
- Accepted mental state of the patient.
Who cannot join
- Patient refusal to participate to the study.
- Mild preeclampsia
- Uncooperative patient or altered sensorium
- Ocular wound
- Pneumonia
- Interstitial lung disease
Show all 9Show fewer
- History of prior ocular trauma or surgery
- Preexisting heart disease
- Known pulmonary disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optic Nerve Sheath Diameter Versus Extra-vascular Lung Water Detected by Ultrasound in Volume Status Prediction in Severe Preeclampsia
A quick, non-invasive, bedside test to assess fluid status of patients with severe preeclampsia would be very helpful to ICU clinicians severe preeclampsia is associated with an increase in extravascular lung water (EVLW), which can be identified by lung ultrasound before appearance of clinical signs of pulmonary edema but this technique still requires several measurements and could be time consuming.
Optic ultrasound is also a safe and repeatable diagnostic tool, which is even quicker and simpler to perform than lung ultrasound. Increased ONSD is associated with increased ICP and it can indirectly reflect the state of intracranial edema that could be a part of generalized edema.
More data on the correlation between ONSD and markers of fluid status (EVLW by ultrasound) are needed before ONSD measurements can be recommended as a guide to fluid management in preeclampsia.
Read the detailed description
Severe preeclampsia (PE) is a progressive multisystem pregnancy disorder. It is considered the second leading cause of maternal death worldwide. Usually, it is diagnosed by the new-onset hypertension and either proteinuria or end-organ dysfunction in the second half of pregnancy.
Acute Pulmonary edema is potentially lethal and is the most common cardiopulmonary complication of preeclampsia. thus, meticulous fluid management of these patients is crucial but it is often difficult because the underlying endothelial damage leads to water, electrolytes, and plasma leakage from the intravascular space which produce significant fluid shifts into the interstitial space resulting in peripheral and/or central (pulmonary and central nervous system) edema. Also, there is a potential for hypovolemia due to the depletion of intravascular volume. Under-resuscitation of preeclampsia patients impairs organ perfusion; while on the other hand fluid overload leads to tissue edema and aggravates pulmonary edema. Therefore, fluid administration must be assessed to preserve organ perfusion, while preventing lung congestion and pulmonary edema.
Early detection of lung congestion would allow early and optimal management of these patients. Lung ultrasound was reported as a useful diagnostic tool which could identify increased levels of extravascular lung water (EVLW) in severe PE before clinical signs of pulmonary edema appear. Consequently, lung ultrasound could guide fluid management and identify those in need for diuretic therapy among severe PE patients. Though it is considered accurate, safe, and non-invasive valuable tool, its use could be limited by the need to several measurements that could be time consuming.
Changes in the Optic Nerve Sheath Diameter (ONSD) detected by ultrasound are considered an important clinical and radiographic demonstration of increased intracranial pressure (ICP) which is one of the consequences of preeclampsia. Therefore, Increased ONSD can indirectly reflect the state of intracranial edema that could be a part of generalized edema.
On ultrasound the ONSD is measured 3 mm posterior to the globe for both eyes. A position of 3 mm behind the globe is recommended because the ultrasound contrast is greatest; the results are more reproducible and the normal optic nerve sheath measures up to 5.0 mm in diameter. An average ONSD greater than 5 mm is considered abnormal and elevated intracranial pressure should be suspected.
Chen et al., studied ONSD and the intravascular volume status of patients after cardiac surgery and found that changes in ONSD can dynamically reflect changes in volume status in patients with postoperative cardiac surgery.
- Conditions
- Pre-Eclampsia
- Being tested
- Ultrasound measurement of Optic nerve sheath diameter
- 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 measurement of Optic nerve sheath diameterDiagnostic test
Ocular ultrasonography was performed with the patients placed in supine position with closed eyes. A layer of ultrasound gel was applied over the closed upper eyelid and the liner high frequency probe 7 - 12 MHz of SonoSite M-Turbo ultrasound machine was placed on the temporal area of the eyelid with the hand holding it resting on the forehead of the patient. The probe is then adjusted to a suitable angle in order to display the entry of the optic nerve into the globe. ONSD is then measured 3mm behind the globe in the transverse plane perpendicular to the optic nerve. For each eye one measurement will be made and the reported ONSD corresponds to the mean of the two values obtained for each patient. it was performed for all enrolled parturients within 24 hour before delivery and at 24 hour post-delivery.
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation of ONSD with EVLW
Ultrasound assessment was performed for all enrolled preeclampsia patients within 24 hour before delivery and at 24 hour post-delivery.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Oct 2019
- Primary completion30 Mar 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- 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
- 54 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sherif M. S. Mowafy, Zagazig University
- Investigators
- Sherif M Mowafy, MD, Principal investigator, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig UniversityMohamed I Elsayed, MD, Study director, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367519
- Sponsor's protocol ID
- 6074-26-4-2020
- Status last verified
- Jul 2020
- First submitted
- 26 Apr 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data that underlie results in the publication
Publications
Hariharan N, Shoemaker A, Wagner S. Pathophysiology of hypertension in preeclampsia. Microvasc Res. 2017 Jan;109:34-37. doi: 10.1016/j.mvr.2016.10.002. Epub 2016 Oct 26. No abstract available.
PubMed 27793558Melchiorre K, Sharma R, Thilaganathan B. Cardiovascular implications in preeclampsia: an overview. Circulation. 2014 Aug 19;130(8):703-14. doi: 10.1161/CIRCULATIONAHA.113.003664. No abstract available.
PubMed 25135127Dennis AT, Solnordal CB. Acute pulmonary oedema in pregnant women. Anaesthesia. 2012 Jun;67(6):646-59. doi: 10.1111/j.1365-2044.2012.07055.x. Epub 2012 Mar 15.
PubMed 22420683Chaiworapongsa T, Chaemsaithong P, Yeo L, Romero R. Pre-eclampsia part 1: current understanding of its pathophysiology. Nat Rev Nephrol. 2014 Aug;10(8):466-80. doi: 10.1038/nrneph.2014.102. Epub 2014 Jul 8.
PubMed 25003615Pretorius T, van Rensburg G, Dyer RA, Biccard BM. The influence of fluid management on outcomes in preeclampsia: a systematic review and meta-analysis. Int J Obstet Anesth. 2018 May;34:85-95. doi: 10.1016/j.ijoa.2017.12.004. Epub 2017 Dec 20.
PubMed 29398426Zieleskiewicz L, Contargyris C, Brun C, Touret M, Vellin A, Antonini F, Muller L, Bretelle F, Martin C, Leone M. Lung ultrasound predicts interstitial syndrome and hemodynamic profile in parturients with severe preeclampsia. Anesthesiology. 2014 Apr;120(4):906-14. doi: 10.1097/ALN.0000000000000102.
PubMed 24694847Shyamsundar M, Attwood B, Keating L, Walden AP. Clinical review: the role of ultrasound in estimating extra-vascular lung water. Crit Care. 2013 Sep 13;17(5):237. doi: 10.1186/cc12710.
PubMed 24041261Ambrozic J, Brzan Simenc G, Prokselj K, Tul N, Cvijic M, Lucovnik M. Lung and cardiac ultrasound for hemodynamic monitoring of patients with severe pre-eclampsia. Ultrasound Obstet Gynecol. 2017 Jan;49(1):104-109. doi: 10.1002/uog.17331. Epub 2016 Dec 1.
PubMed 27736042Sekhon MS, Griesdale DE, Robba C, McGlashan N, Needham E, Walland K, Shook AC, Smielewski P, Czosnyka M, Gupta AK, Menon DK. Optic nerve sheath diameter on computed tomography is correlated with simultaneously measured intracranial pressure in patients with severe traumatic brain injury. Intensive Care Med. 2014 Sep;40(9):1267-74. doi: 10.1007/s00134-014-3392-7. Epub 2014 Jul 18.
PubMed 25034476Pordeus ACB, Katz L, Soares MC, Maia SB, Amorim MMR. Acute pulmonary edema in an obstetric intensive care unit: A case series study. Medicine (Baltimore). 2018 Jul;97(28):e11508. doi: 10.1097/MD.0000000000011508.
PubMed 29995818ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
PubMed 30575675Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
PubMed 22392031Picano E, Pellikka PA. Ultrasound of extravascular lung water: a new standard for pulmonary congestion. Eur Heart J. 2016 Jul 14;37(27):2097-104. doi: 10.1093/eurheartj/ehw164. Epub 2016 May 12.
PubMed 27174289Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.
PubMed 22258019
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Nerve Sheath Diameter Versus Extra-vascular Lung Water Detected by Ultrasound in Volume Status Prediction in Severe Preeclampsia
- ClinicalTrials.gov ID
- NCT04367519
- Acronym / sponsor ID
- 6074-26-4-2020
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 29 Apr 2020 (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.
A quick, non-invasive, bedside test to assess fluid status of patients with severe preeclampsia would be very helpful to ICU clinicians severe preeclampsia is associated with an increase in extravascular lung water (EVLW), which can be identified by lung ultrasound before appearance of clinical signs of pulmonary edema but this technique still requires several measurements and could be time consuming.
Optic ultrasound is also a safe and repeatable diagnostic tool, which is even quicker and simpler to perform than lung ultrasound. Increased ONSD is associated with increased ICP and it can indirectly reflect the state of intracranial edema that could be a part of generalized edema.
More data on the correlation between ONSD and markers of fluid status (EVLW by ultrasound) are needed before ONSD measurements can be recommended as a guide to fluid management in preeclampsia.
Detailed description
Severe preeclampsia (PE) is a progressive multisystem pregnancy disorder. It is considered the second leading cause of maternal death worldwide. Usually, it is diagnosed by the new-onset hypertension and either proteinuria or end-organ dysfunction in the second half of pregnancy.
Acute Pulmonary edema is potentially lethal and is the most common cardiopulmonary complication of preeclampsia. thus, meticulous fluid management of these patients is crucial but it is often difficult because the underlying endothelial damage leads to water, electrolytes, and plasma leakage from the intravascular space which produce significant fluid shifts into the interstitial space resulting in peripheral and/or central (pulmonary and central nervous system) edema. Also, there is a potential for hypovolemia due to the depletion of intravascular volume. Under-resuscitation of preeclampsia patients impairs organ perfusion; while on the other hand fluid overload leads to tissue edema and aggravates pulmonary edema. Therefore, fluid administration must be assessed to preserve organ perfusion, while preventing lung congestion and pulmonary edema.
Early detection of lung congestion would allow early and optimal management of these patients. Lung ultrasound was reported as a useful diagnostic tool which could identify increased levels of extravascular lung water (EVLW) in severe PE before clinical signs of pulmonary edema appear. Consequently, lung ultrasound could guide fluid management and identify those in need for diuretic therapy among severe PE patients. Though it is considered accurate, safe, and non-invasive valuable tool, its use could be limited by the need to several measurements that could be time consuming.
Changes in the Optic Nerve Sheath Diameter (ONSD) detected by ultrasound are considered an important clinical and radiographic demonstration of increased intracranial pressure (ICP) which is one of the consequences of preeclampsia. Therefore, Increased ONSD can indirectly reflect the state of intracranial edema that could be a part of generalized edema.
On ultrasound the ONSD is measured 3 mm posterior to the globe for both eyes. A position of 3 mm behind the globe is recommended because the ultrasound contrast is greatest; the results are more reproducible and the normal optic nerve sheath measures up to 5.0 mm in diameter. An average ONSD greater than 5 mm is considered abnormal and elevated intracranial pressure should be suspected.
Chen et al., studied ONSD and the intravascular volume status of patients after cardiac surgery and found that changes in ONSD can dynamically reflect changes in volume status in patients with postoperative cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Singleton Pregnant female complicated with severe preeclampsia. severe preeclampsia was determined by the presence of one or more of the following features using the American College of Obstetricians and Gynecologists severe features : * Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg on two occasions at least 4 hours apart * Thrombocytopenia (platelet count less than 100,000/L) * Impaired liver function indicated by elevated liver enzymes (to twice the upper limit normal concentration), and severe persistent right upper quadrant or epigastric pain not responding to medications and not explained by another diagnosis. * Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or doubling of the serum creatinine concentration in the absence of other renal disease) * Pulmonary edema * New-onset headache unresponsive to medications and not accounted for by alternative diagnoses * Visual disturbances
Key inclusion criteria (4 listed)
- Patient acceptance.
- Singleton Pregnant female complicated with severe preeclampsia
- Age 18-40 years old.
- Accepted mental state of the patient.
Key exclusion criteria (9 listed)
- Patient refusal to participate to the study.
- Mild preeclampsia
- Uncooperative patient or altered sensorium
- Ocular wound
- Pneumonia
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 measurement of Optic nerve sheath diameterOcular ultrasonography was performed with the patients placed in supine position with closed eyes. A layer of ultrasound gel was applied over the closed upper eyelid and the liner high frequency probe 7 - 12 MHz of SonoSite M-Turbo ultrasound machine was placed on the temporal area of the eyelid with the hand holding it resting on the forehead of the patient. The probe is then adjusted to a suitable angle in order to display the entry of the optic nerve into the globe. ONSD is then measured 3mm behind the globe in the transverse plane perpendicular to the optic nerve. For each eye one measurement will be made and the reported ONSD corresponds to the mean of the two values obtained for each patient. it was performed for all enrolled parturients within 24 hour before delivery and at 24 hour post-delivery. | Diagnostic test | – |
Primary outcome
the correlation of ONSD with EVLW
Time frame: 24 hour
Ultrasound assessment was performed for all enrolled preeclampsia patients within 24 hour before delivery and at 24 hour post-delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Background: PubMed 27793558Hariharan N, Shoemaker A, Wagner S. Pathophysiology of hypertension in preeclampsia. Microvasc Res. 2017 Jan;109:34-37. doi: 10.1016/j.mvr.2016.10.002. Epub 2016 Oct 26. No abstract available.
- Background: PubMed 25135127Melchiorre K, Sharma R, Thilaganathan B. Cardiovascular implications in preeclampsia: an overview. Circulation. 2014 Aug 19;130(8):703-14. doi: 10.1161/CIRCULATIONAHA.113.003664. No abstract available.
- Background: PubMed 22420683Dennis AT, Solnordal CB. Acute pulmonary oedema in pregnant women. Anaesthesia. 2012 Jun;67(6):646-59. doi: 10.1111/j.1365-2044.2012.07055.x. Epub 2012 Mar 15.
- Background: PubMed 25003615Chaiworapongsa T, Chaemsaithong P, Yeo L, Romero R. Pre-eclampsia part 1: current understanding of its pathophysiology. Nat Rev Nephrol. 2014 Aug;10(8):466-80. doi: 10.1038/nrneph.2014.102. Epub 2014 Jul 8.
- Background: PubMed 29398426Pretorius T, van Rensburg G, Dyer RA, Biccard BM. The influence of fluid management on outcomes in preeclampsia: a systematic review and meta-analysis. Int J Obstet Anesth. 2018 May;34:85-95. doi: 10.1016/j.ijoa.2017.12.004. Epub 2017 Dec 20.
- Background: PubMed 24694847Zieleskiewicz L, Contargyris C, Brun C, Touret M, Vellin A, Antonini F, Muller L, Bretelle F, Martin C, Leone M. Lung ultrasound predicts interstitial syndrome and hemodynamic profile in parturients with severe preeclampsia. Anesthesiology. 2014 Apr;120(4):906-14. doi: 10.1097/ALN.0000000000000102.
- Background: PubMed 24041261Shyamsundar M, Attwood B, Keating L, Walden AP. Clinical review: the role of ultrasound in estimating extra-vascular lung water. Crit Care. 2013 Sep 13;17(5):237. doi: 10.1186/cc12710.
- Background: PubMed 27736042Ambrozic J, Brzan Simenc G, Prokselj K, Tul N, Cvijic M, Lucovnik M. Lung and cardiac ultrasound for hemodynamic monitoring of patients with severe pre-eclampsia. Ultrasound Obstet Gynecol. 2017 Jan;49(1):104-109. doi: 10.1002/uog.17331. Epub 2016 Dec 1.
- Background: PubMed 25034476Sekhon MS, Griesdale DE, Robba C, McGlashan N, Needham E, Walland K, Shook AC, Smielewski P, Czosnyka M, Gupta AK, Menon DK. Optic nerve sheath diameter on computed tomography is correlated with simultaneously measured intracranial pressure in patients with severe traumatic brain injury. Intensive Care Med. 2014 Sep;40(9):1267-74. doi: 10.1007/s00134-014-3392-7. Epub 2014 Jul 18.
- Background: PubMed 29995818Pordeus ACB, Katz L, Soares MC, Maia SB, Amorim MMR. Acute pulmonary edema in an obstetric intensive care unit: A case series study. Medicine (Baltimore). 2018 Jul;97(28):e11508. doi: 10.1097/MD.0000000000011508.
- Background: PubMed 30575675ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
- Background: PubMed 22392031Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
- Individual participant dataSharing planned: Yes. all individual participant data that underlie results in the publication
Related trials for Pre-Eclampsia
RecruitingEarly Phase 1
Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia
Preeclampsia, Endothelial Function
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Active, not recruitingEarly Phase 1
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
Preeclampsia Postpartum
Active, not recruitingEarly Phase 1
Daily Aspirin Treatment After Preeclampsia
Preeclampsia
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, 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.
Sherif M Mowafy, MD principal investigator
Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
Mohamed I Elsayed, MD study director
Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
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 Zagazig 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 16 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the correlation of ONSD with EVLW (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04367519, which also lists 14 linked publications.
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 16 Jul 2020.