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

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

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 .

Study Overview

• Status: Completed
• Conditions: Hypertensive Disorder of Pregnancy
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 1238

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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).

Description

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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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

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 Names: 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 Names: 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 Names: 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 Names: magnesium Sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
control of blood pressure	keeping blood pressure at or below 140/90	24 hours after delivery

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: January 21, 2018
• First Submitted That Met QC Criteria: January 21, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 21, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Pregnancy Complications; Hypertension, Pregnancy-Induced; Toxemia; Hypertension; Eclampsia; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: 22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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