Impact of Body Mass Index on Serum Maternal and Fetal Mag... | NCT03928691

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

NCT03928691

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 23, 2021Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Pre-Eclampsia

Interventions

Magnesium Sulfate

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2019Actual

Primary Completion Date

Aug 2021Estimated

Completion Date

Nov 2021Estimated

First Submitted Date

Apr 24, 2019

First Submission Date that Met QC Criteria

Apr 24, 2019

First Posted Date

Apr 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2021

Last Update Posted Date

Apr 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the percentage of women reaching the Mg therapeutic level.	the Mg therapeutic level of 4,8 mg/dl.	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas	Recruiting	Assiut	Cairo Governorate	002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008278	Magnesium Sulfate

Ancestor Terms

ID	Term
D017616	Magnesium Compounds
D007287	Inorganic Chemicals
D013431	Sulfates
D013464	Sulfuric Acids

Browse Leaves

Not provided

Browse Branches

Not provided