Clinical trial NCT03412552: Risk Analysis of Intensive Care Mangement on Maternal and Fetal Outcome of Severe Preeclampsia and Eclampsia
Official title: Risk Analysis of Intensive Care Management on Maternal and Fetal Outcome of Severe Preeclampsia and Eclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertensive Disorder of Pregnancy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 1238
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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

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

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Primary outcomes:
measure: control of blood pressure
timeFrame: 24 hours after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: professor
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References: