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Trial record 3 of 147 for:    severe preeclampsia AND hypertensive disorders

Risk Analysis of Intensive Care Mangement on Maternal and Fetal Outcome of Severe Preeclampsia and Eclampsia

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ClinicalTrials.gov Identifier: NCT03412552
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Brief Summary:

Laboratory monitoring of patients included serial measurement of complete blood cell count, liver function tests, coagulation profile, and renal function tests.

ICU management during conduction of the research study included the following:

Control of convulsions using magensium sulphate. Control of blood pressure Diastolic blood pressure above 110 mmHg, nifedipine was administered.A plasma volume expansion with saline was used in all women to maintain sufficient intravascular volume. Delivery was performed immediately after hemodynamic stabilization and clinical control of general condition .


Condition or disease Intervention/treatment
Hypertensive Disorder of Pregnancy Drug: MgSO4

Detailed Description:

Laboratory monitoring of patients included serial measurement of complete blood cell count, liver function tests, coagulation profile, and renal function tests.

ICU management included the following:

Control of convulsions by Loading dose of magensium sulphate (4-6g I.V), given over 20 minutes in 100 ml of dextrose then Maintenance dose (4-6g) magensium sulphate in 500 cc dextrose given over 8 hours using continuous IV drip.Control of blood pressure if Diastolic blood pressure above 110 mmHg, nifedipine was administered. Delivery was performed immediately after hemodynamic stabilization and clinical control of general condition .Termination of gestation decision was based on the the presence of maternal complications, fetal distress.After delivery the patient is retrurned to ICU under clinical and careful observation of the following:Heart rate, blood pressure,every 15 min,Temperature and respiratory rate ,evey 4 hours. Duration of admission in the ICU was assessed


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Study Type : Observational
Actual Enrollment : 1238 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Analysis of Intensive Care Management on Maternal and Fetal Outcome of Severe Preeclampsia and Eclampsia
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
severe preeclampsia without HELLP syndrome
severe preeclampsia if they met one or more of the following criteria of The American College of Obstetricians and Gynecologists (10): systolic blood pressure >160 mm/ Hg or diastolic blood pressure >110 mm/Hg, headache, epigastric or right-upper-quadrant pain, visual disturbances,pulmonary edema, and proteinuria (urinary protein level >5 g/24 h).Women with severe preeclampsia selected for analysis also met all of the following laboratory criteria: platelet count ≥150,000/ mm3, serum lactate dehydrogenase <600 IU /dL, serum total bilirubin <1.2 mg/dL and serum aspartate aminotransferase <70IU/L
Drug: MgSO4
Loading dose of magensium sulphate (4-6g I.V), given over 20 minutes in 100 ml of dextrose, Maintenance dose (4-6g) magensium sulphate in 500 cc dextrose given over 8 hours using continuous IV drip
Other Name: magnesium Sulfate

eclampsia without HELLP syndrome
Eclampsia was defined as tonic-clonic seizures occurring in patient diagnosed by preeclampsia patient. Any causes for convulsion other than eclampsia were excluded
Drug: MgSO4
Loading dose of magensium sulphate (4-6g I.V), given over 20 minutes in 100 ml of dextrose, Maintenance dose (4-6g) magensium sulphate in 500 cc dextrose given over 8 hours using continuous IV drip
Other Name: magnesium Sulfate

eclampsia with HELLP syndrome
Eclampsia was defined as tonic-clonic seizures occurring in patient diagnosed by preeclampsia patient. Any causes for convulsion other than eclampsia were excluded.HELLP syndrome was defined by the clinical presentation of PET in association with thrombocytopenia (<150.000 cells/ul), hemolysis and elevated liver enzmes (elevated transaminases and lactic dyhydrogenases activities)
Drug: MgSO4
Loading dose of magensium sulphate (4-6g I.V), given over 20 minutes in 100 ml of dextrose, Maintenance dose (4-6g) magensium sulphate in 500 cc dextrose given over 8 hours using continuous IV drip
Other Name: magnesium Sulfate

HELLP syndrome without eclampsia
HELLP syndrome was defined by the clinical presentation of PET in association with thrombocytopenia (<150.000 cells/ul), hemolysis and elevated liver enzmes (elevated transaminases and lactic dyhydrogenases activities)
Drug: MgSO4
Loading dose of magensium sulphate (4-6g I.V), given over 20 minutes in 100 ml of dextrose, Maintenance dose (4-6g) magensium sulphate in 500 cc dextrose given over 8 hours using continuous IV drip
Other Name: magnesium Sulfate




Primary Outcome Measures :
  1. control of blood pressure [ Time Frame: 24 hours after delivery ]
    keeping blood pressure at or below 140/90



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients were diagnosed as severe preeclampsia if met one or more of the American College of Obstetricians and Gynecologists Eclampsia was defined as tonic-clonic seizures occurring in patient diagnosed by preeclampsia patient. .HELLP syndrome was defined by the clinical presentation of PET in association with thrombocytopenia (<150.000 cells/ul), hemolysis and elevated liver enzmes (elevated transaminases and lactic dyhydrogenases activities).
Criteria

Inclusion Criteria:

  • women with severe preeclampsia or eclampsia or HELLP syndrome admitted to ICU

Exclusion Criteria:

Non eclamptic causes of fits, including hysterical causes and epilepsy

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412552


Locations
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Egypt
Kasr Alainy medical school
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged professor

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Responsible Party: Ahmed Maged, professor, Cairo University
ClinicalTrials.gov Identifier: NCT03412552     History of Changes
Other Study ID Numbers: 22
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Toxemia
Eclampsia
Pregnancy Complications
Infection
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents