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

NCT03412552 | Completed DMC FDA Drug

• 1 other identifier: 22
• Study Type: observational
• Target: 1,238
• Locations: 1 country
• Sites: 1

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 .

Conditions

Hypertensive Disorder of Pregnancy

Outcome Measures

Primary Outcomes (1)

• control of blood pressure

  keeping blood pressure at or below 140/90

  24 hours after delivery

Study Arms (4)

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

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

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

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

Interventions

MgSO4 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

Also known as: magnesium Sulfate

HELLP syndrome without eclampsia; eclampsia with HELLP syndrome; eclampsia without HELLP syndrome; severe preeclampsia without HELLP syndrome

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• Non eclamptic causes of fits, including hysterical causes and epilepsy

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Toxemia

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ahmed Maged

  professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 26, 2018
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: December 30, 2017
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

EG (1)