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

NCT ID: NCT03412552

Last Updated: 2018-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1238 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2017-12-30

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

Conditions

Hypertensive Disorder of Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

MgSO4

Intervention Type: DRUG

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

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

MgSO4

Intervention Type: DRUG

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

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)

MgSO4

Intervention Type: DRUG

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

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)

MgSO4

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

magnesium Sulfate

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maged

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

Kasr Alainy medical school

Cairo, , Egypt

Countries

Egypt

Other Identifiers

22

Identifier Type: -

Identifier Source: org_study_id