Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries
NCT ID: NCT05674565
Last Updated: 2023-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
336 participants
INTERVENTIONAL
2023-01-20
2024-07-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Loading dose only
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
Magnesium sulfate loading dose only
4 gm MgSo4 loading over 20 minutes within one hour before delivery
Loading plus 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.
Magnesium sulfate loading with maintenance dose
4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery
Control
comparable number of women who did not receive magnesium sulphate neuroprotection for any reason
No interventions assigned to this group
Interventions
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Magnesium sulfate loading with maintenance dose
4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery
Magnesium sulfate loading dose only
4 gm MgSo4 loading over 20 minutes within one hour before delivery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
* Caution regarding dosage for patients with renal impairment
* Preterm delivery after 34 weeks
24 Weeks
34 Weeks
ALL
No
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Hytham Atia
Associate professor
Principal Investigators
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Hytham Atia, M.D.
Role: STUDY_CHAIR
Zagazig University
Amro Alnemr, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zagazig University
Mohamed Lashin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zagazig University
Sherief M El Gebaly, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zagazig University
Mohamed Arafa, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zagazig University
Locations
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Faculty of medicine, Zagazig University
Zagazig, Sharqia Province, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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
Other Identifiers
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MGSULPH NEUROPROTECT EGYPT
Identifier Type: -
Identifier Source: org_study_id
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