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

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ClinicalTrials.gov Identifier: NCT03928691
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief 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.

Condition or disease Intervention/treatment
Pre-Eclampsia Drug: Magnesium Sulfate

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Body Mass Index on Serum Maternal and Fetal Magnesium Level in Pregnant Recipients of Magnesium Sulphate
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020


Group/Cohort Intervention/treatment
Study group
pregnant women admitted to Women's Health Hospital , Assiut university during 2019-2020 will be counseled to participate in the study
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.




Primary Outcome Measures :
  1. the percentage of women reaching the Mg therapeutic level. [ Time Frame: 24 hours ]
    the Mg therapeutic level of 4,8 mg/dl.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

women included will be classified according to BMI underwieght ( less than 18.85) , Normal weight (18.5-24.9)

, Overweight (25-29.9) and obese (30 or more)

Criteria

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.


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Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03928691     History of Changes
Other Study ID Numbers: MAGPET
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents