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Clinical Trials/NCT03412552
NCT03412552
Completed
Not Applicable

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

Cairo University1 site in 1 country1,238 target enrollmentOctober 1, 2015

Overview

Phase
Not Applicable
Intervention
MgSO4
Conditions
Hypertensive Disorder of Pregnancy
Sponsor
Cairo University
Enrollment
1238
Locations
1
Primary Endpoint
control of blood pressure
Status
Completed
Last Updated
8 years ago

Overview

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 .

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

Registry
clinicaltrials.gov
Start Date
October 1, 2015
End Date
December 30, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Maged

professor

Cairo University

Eligibility 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

Arms & Interventions

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

Intervention: MgSO4

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

Intervention: MgSO4

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)

Intervention: MgSO4

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)

Intervention: MgSO4

Outcomes

Primary Outcomes

control of blood pressure

Time Frame: 24 hours after delivery

keeping blood pressure at or below 140/90

Study Sites (1)

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