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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

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

Clinicaltrials.gov identifier NCT03928691

Recruitment Status Not yet recruiting

First Posted April 26, 2019

Last update posted April 26, 2019

Study Description

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:Pre-Eclampsia
  • Intervention/Treatment: Drug: Magnesium Sulfate
  • Phase: N/A
Detailed Description

N/A

Study Design
  • 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
Groups and Cohorts
Groups/Cohorts 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.
Outcome Measures
  • 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.
Eligibility Criteria
  • 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.

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Assiut University

More Information
  • Responsible Party: 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Eclampsia Pre-Eclampsia