Condition of newborns of mothers with convulsions, mother being treated with a medication, magnesium sulphate

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/08/004892
• Date of registration: 20-08-2014
• Prospective Registration: No
• Primary sponsor: BURDWAN MEDICAL COLLEGE BURDWAN
• Public title: Condition of newborns of mothers with convulsions, mother being treated with a medication, magnesium sulphate
• Scientific title: ASSESSMENT OF BLOOD MAGNESIUM LEVELS AND ITS OUTCOME IN NEONATES OF ECLAMPTIC MOTHERS TREATED WITH LOW DOSE MAGNESIUM SULPHATE REGIMEN
• Date of first enrolment: 01-06-2011
• Target sample size: 100
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9176
• Study type: Observational
• Study design: Single Arm Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant Blinded
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: DR PATRALEKHA RAYCHAUDHURI
• Affiliation: BURDWAN MEDICAL COLLEGE, BURDWAN

• Name: MONALISA DAS
• Affiliation: BURDWAN MEDICAL COLLEGE, BURDWAN

Key inclusion & exclusion criteria

Inclusion criteria: 1. Eclampsia was diagnosed if there was h/o generalized tonic clonic convulsions with or without elevated blood pressure and proteinuria (by dipstick method) in the absence of any underlying seizure disorders after 20 wks of gestational age.

2. All cases of antepartum, intrapartum eclampsia, presenting in obstetric emergency, labour rooms and/or wards who gave informed consent to participate in the study were included in the study.

3. Neonates (of eclamptic mothers), of gestational age > 28 wks, were included in the study.
Exclusion criteria: Eclampsia patients who had renal failure, severe pulmonary oedema with respiratory failure, having received magnesium sulphate and/or other anticonvulsant before coming to our hospital, cerebrovascular accident and Disseminated Intravascular Coagulation (DIC) were excluded from the from the present study. Neonates (of eclamptic mothers), of gestational age < 28 wks were excluded from the present study.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Neonates of Eclamptic mothers

Intervention(s)

Intervention1: Nil: The low - dose regimen consisted of the following: a loading dose of 3g of magnesium sulphate intravenously plus a 2.5g intramuscular injection in each buttock (for a total of 8g of magnesium sulphate), followed by a maintenance dose of 2.5g administered intramuscularly every 4 hrs alternately in each buttock over the 24 hrs that followed the last seizure. The low - dose magnesium sulphate regimen is administered to eclamptic mothers; and neonates (of these eclamptic mothers) are not administered any magnesium sulphate

Primary Outcome(s)

Assessment of neonatal outcome in terms of Apgar score(5min), time to first stool ( or 24 hrs), time to first void ( or 48 hrs) , admission to NICU, no. of episodes of feeding intolerance (3 or 3), %age of neonates with respiratory depression, %age of neonates with hypotonia.Timepoint: Early neonatal period

Secondary Outcome(s)

Cord blood magnesium level & maternal blood magnesium level at the time of deliveryTimepoint: At the time of delivery

Secondary ID(s)

Memo.No.BMC/PG/1174

Source(s) of Monetary Support

BURDWAN MEDICAL COLLEGE & HOSPITAL, BURDWAN

Ethics review

Status: Approved
Approval date: 28/02/2011
Contact:

Ethical Committee, Burdwan Medical College, Burdwan