A Clinical trial to study two different dosage regimes (Dhaka regime and loading dose only regime) of the drug magnesium sulphate used to prevent the development of eclampsia in women with severe pre-eclampsia
- Conditions
- Health Condition 1: O141- Severe pre-eclampsiaHealth Condition 2: null- Women with Severe Pre-eclampsia
- Registration Number
- CTRI/2012/04/002553
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 402
•Any pregnant woman with Severe Pre- eclampsia as per the ACOG Criteria:
oSystolic blood pressure of 160 mm Hg or higher or diastolic blood pressure of 110 mm Hg or higher on two occasions at least 6 hours apart.
oProteinuria of 5 gm or higher in a 24-hour urine specimen or 3+ or greater on two random urine samples collected at least 4 hours apart.
oOliguria of less than 500 ml in 24 hours.
oCerebral or visual disturbances
oPulmonary edema or cyanosis
oEpigastric or right upper-quadrant pain
oImpaired liver function
oThrombocytopenia
oFetal growth restriction
oMultiple Pregnancy
oPlatelet count < 50,000/mm3
oPlasma creatinine value >= 2mg/dl
oComatose patients
oDeranged coagulation profile
oKnown case of myasthenia gravis
oKnown case of seizure disorder
oPatients with Eclampsia (defined as presence of new-onset grand mal seizures in a woman with preeclampsia).
oHypersensitivity to Magnesium.
oWomen who have received have received magnesium sulphate therapy before being referred.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method