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

Completed

• Conditions: Severe pre-eclampsia, Women with Severe Pre-eclampsia,

• Registration Number: CTRI/2012/04/002553
• Lead Sponsor: JIPMER

Brief Summary

Use of magnesium sulphatefor the prevention of eclampsia, popularized by the Magpie trial, has been ableto decrease the mortality and morbidity of women with pre-eclampsia. Experience using theshorter regimes for seizure prevention has been reported in women witheclampsia; however use for seizure prophylaxis in preeclampsia is limited worldliterature. There are no such studies reported from Indian subcontinent. So we plan to conduct to conduct a randomized control studycomparing the commonly used regimes for seizure prophylaxis. We plan this study with the hypotheisis that  "Parenteralloading dose only regime is equally effective and more safe than theconventional low dose  regime ofmagnesium sulphate  for the prevention ofeclampsia in women with sever preeclampsia".

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Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-04
• Study Completion: 2013-03-31
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• •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.

Exclusion Criteria

• 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
Development of Eclampsia defined as new-onset grand mal seizures in a woman with preeclampsia	Within 48 hours postpartum

Secondary Outcome Measures

Name	Time	Method
Maternal Death	o Serious Maternal Morbidity

Trial Locations

Locations (1)

Department of Obstetric and Gynecology; 🇮🇳 Pondicherry, PONDICHERRY, India

Department of Obstetric and Gynecology

🇮🇳Pondicherry, PONDICHERRY, India

Dr Anish Keepanasseril

Principal investigator

8903307141

keepan_r@yahoo.com