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

NCT03928691 | Unknown

• 1 other identifier: MAGPET
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• the percentage of women reaching the Mg therapeutic level.

  the Mg therapeutic level of 4,8 mg/dl.

  24 hours

Study Arms (1)

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

Interventions

Magnesium Sulfate DRUG

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.

Study group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• \- women with more than 34 weeks gestation and with any contraindication for Magnesium Sulphate intake like severe renal impairment or myasthenia gravis.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 26, 2019
• Study Start: June 30, 2019
• Primary Completion: August 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)