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Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

Primary Purpose

Premature Birth, NEUROPROTECTION, MAGNESIUM SULPHATE

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium sulfate loading with maintenance dose
Magnesium sulfate loading dose only
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring CEREBRAL PALSY, PRETERM BIRTH, NEUROPROTECTION, NEONATAL DEATH, MAGNESIUM SULPHATE

Eligibility Criteria

24 Weeks - 34 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Women at risk of preterm birth who are between 24+0 and 33+6 weeks of gestation. When early preterm birth is planned or expected within 24 h, regardless of: Plurality or parity Reason for the risks of preterm birth Anticipated mode of birth Whether antenatal corticosteroids have been given or not Exclusion Criteria: Women with known Hypersensitivity to magnesium Caution regarding dosage for patients with renal impairment Preterm delivery after 34 weeks

Sites / Locations

  • Faculty of medicine, Zagazig UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Loading dose only

Loading plus maintenance dose

Control

Arm Description

Those receiving only the loading dose of magnesium sulphate 4 gm infusion over 20 minutes therapy within one hour before delivery without the maintenance dose

Receiving magnesium sulphate loading 4 gm infusion over 20 minutes, followed by maintenance therapy 1gm per hour infusion until delivery or completion of 24 hours, the sooner.

comparable number of women who did not receive magnesium sulphate neuroprotection for any reason

Outcomes

Primary Outcome Measures

Neonatal Neurological insult
The incidence of neurological insults during the first year of life (including cerebral palsy, brain leukomalacia, intraventricular hemorrhage, and neonatal seizures)
Maternal toxicity
Risk of maternal magnesium sulphate toxicity (affected reflexes, respiratory and cardiac), postpartum hemorrhage.
Postpartum hemorrhage
Risk of primary postpartum hemorrhage

Secondary Outcome Measures

Late appearing neurologic insults
Risk of gross motor delay, epilepsy, impaired fine motor skills, sensorineural (hearing and vision) impairment, and possibly two years of age developmental quotient.
Neonatal death
Death within first 28 days after delivery

Full Information

First Posted
November 19, 2022
Last Updated
July 11, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05674565
Brief Title
Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries
Official Title
The Neuroprotective Impact of Magnesium Sulphate Therapy for Preterm Deliveries. Loading Dose Alone Strategy Versus Loading Plus Maintenance Dose Strategy.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Cochrane systematic review has confirmed that fetal exposure to magnesium sulphate given before preterm birth has a neuroprotective role. This review also showed a significant reduction in the rate of gross motor dysfunction in early childhood. Early Preterm birth (< 34+0 weeks) and very low birthweight (< 1,500 g) are the principal risk factors for cerebral palsy. Multiple pregnancy accounts for over 10% of preterm births and has a higher incidence of cerebral palsy than singleton pregnancy (twins have 7 times and triplets 47 times the risk of cerebral palsy compared with singletons).
Detailed Description
Many of these patients come or get diagnosed as eminent preterm delivery very soon before the real delivery happens and are not able to complete the recommended therapy of loading and maintenance strategy for at least complete 4 hours before delivery. Till now, there is a gap and lack of knowledge regarding the value of loading dose only as sufficient and effective strategy for neuroprotection compared to full therapy, which needs more health costs, longer monitoring and carries more risk for the patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, NEUROPROTECTION, MAGNESIUM SULPHATE, Cerebral Palsy, Neonatal Death
Keywords
CEREBRAL PALSY, PRETERM BIRTH, NEUROPROTECTION, NEONATAL DEATH, MAGNESIUM SULPHATE

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Loading dose only
Arm Type
Experimental
Arm Description
Those receiving only the loading dose of magnesium sulphate 4 gm infusion over 20 minutes therapy within one hour before delivery without the maintenance dose
Arm Title
Loading plus maintenance dose
Arm Type
Experimental
Arm Description
Receiving magnesium sulphate loading 4 gm infusion over 20 minutes, followed by maintenance therapy 1gm per hour infusion until delivery or completion of 24 hours, the sooner.
Arm Title
Control
Arm Type
No Intervention
Arm Description
comparable number of women who did not receive magnesium sulphate neuroprotection for any reason
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate loading with maintenance dose
Other Intervention Name(s)
complete therapy
Intervention Description
4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate loading dose only
Other Intervention Name(s)
short therapy
Intervention Description
4 gm MgSo4 loading over 20 minutes within one hour before delivery
Primary Outcome Measure Information:
Title
Neonatal Neurological insult
Description
The incidence of neurological insults during the first year of life (including cerebral palsy, brain leukomalacia, intraventricular hemorrhage, and neonatal seizures)
Time Frame
at 18 months age after delivery
Title
Maternal toxicity
Description
Risk of maternal magnesium sulphate toxicity (affected reflexes, respiratory and cardiac), postpartum hemorrhage.
Time Frame
from start of therapy, till 12 hours after end of therapy
Title
Postpartum hemorrhage
Description
Risk of primary postpartum hemorrhage
Time Frame
first 24 hours after delivery
Secondary Outcome Measure Information:
Title
Late appearing neurologic insults
Description
Risk of gross motor delay, epilepsy, impaired fine motor skills, sensorineural (hearing and vision) impairment, and possibly two years of age developmental quotient.
Time Frame
at 24 months age after delivery
Title
Neonatal death
Description
Death within first 28 days after delivery
Time Frame
28 days from birth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women at risk of preterm birth who are between 24+0 and 33+6 weeks of gestation. When early preterm birth is planned or expected within 24 h, regardless of: Plurality or parity Reason for the risks of preterm birth Anticipated mode of birth Whether antenatal corticosteroids have been given or not Exclusion Criteria: Women with known Hypersensitivity to magnesium Caution regarding dosage for patients with renal impairment Preterm delivery after 34 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hytham Atia, M.D
Phone
+9660538308500
Email
hythamatia@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amro Alnemr, M.D.
Phone
+201224581528
Email
amrabmohsen@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hytham Atia, M.D.
Organizational Affiliation
Zagazig University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amro Alnemr, M.D.
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Lashin, M.D.
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherief M El Gebaly, M.D.
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Arafa, M.D.
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine, Zagazig University
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44519
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hytham Atia, M.D.
Email
hythamatia@gmail.com
First Name & Middle Initial & Last Name & Degree
Amro El Nemr, M.D.
First Name & Middle Initial & Last Name & Degree
Mohamed Lashin, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Shennan A, Suff N, Jacobsson B, Simpson JL, Norman J, Grobman WA, Bianchi A, Mujanja S, Valencia CM, Mol BW. FIGO good practice recommendations on magnesium sulfate administration for preterm fetal neuroprotection. Int J Gynecol Obstet. 2021;155(1):31-33. doi:10.1002/ijgo.13856.
Results Reference
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Citation
Usman S, Foo L, Tay J, Bennett PR, Lees C. Use of magnesium sulfate in preterm deliveries for neuroprotection of the neonate. Obstet Gynaecol. 2017;19(1):21-28. doi:10.1111/tog.12328
Results Reference
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Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

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