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NCT03928691 Clinical Trial

Impact of Body Mass Index on Serum Maternal and Fetal Magnesium Level

Pre-Eclampsia Clinical Trial

Official title:
Impact of Body Mass Index on Serum Maternal and Fetal Magnesium Level in Pregnant Recipients of Magnesium Sulphate

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03928691
Other study ID # MAGPET
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 30, 2019
Est. completion date November 2021

Study information
Verified date April 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Magnesium sulphate is an inorganic salt with multiple therapeutic applications in medicine it has been widely utilized and studied on a diverse set of conditions such as asthma, cardiac arrhythmia and stroke. In pregnant women ,MgSo4 has been used in many cases such as for seizures prophylaxis in preeclampsia, tocolysis in preterm labour and for fetal neuroprotection in immenint preterm delivery.MgSo4 has been used as the standard drug for tocolysis in preterm labour and other drugs have been compared to it.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date November 2021
Est. primary completion date August 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion criteria: pregnant women 34 weeks or less admitted to Women's Health Hospital with a diagnosis of : - sever preeclampsia. It is defined as 1- blood pressure 160/110 mmHg or more 2- proteinurea (+3 or more by dipstick) 3-HELLP syndrome - threatened preterm labour that will receive Magnesium Sulphate either for tocolysis or neuroprotection. Exclusion criteria: - women with more than 34 weeks gestation and with any contraindication for Magnesium Sulphate intake like severe renal impairment or myasthenia gravis.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Magnesium Sulfate
4 gram MgSo4 diluted in 150 cc saline infused IV within 30 minutes as loading dose then the patient will receive the maintenance dose of 1gram MgSo4 per hour for 6 hours.

Locations
Country Name City State
Egypt Ahmed Abbas Assiut Cairo

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary the percentage of women reaching the Mg therapeutic level. the Mg therapeutic level of 4,8 mg/dl. 24 hours
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