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Magnesium Sulfate for Fetal Neuroprotection

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04401852
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
15.4
Anticipated Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological changes according to NICE guidelines 2017) in any of the groups will receive the allocated treatment at least 20 minute before the procedure (emergency CS).

measures to reduce the effect of hypoxia will be applied to all participate through:

  • The position of the mother will be changed to left lateral position (allow increased blood supply).

  • I.V. fluid bolus (to avoid maternal dehydration).

  • Oxytocin or cervical ripening agent will be discontinued.

  • Fetal heart rate monitoring with cardiotocography will be attempted.

  • If umbilical cord prolapse is noted, elevate the presenting fetal part until preparing for emergency operative delivery.

  • After birth, Apgar score will be used to identify distress newborns that need resuscitation.

The study comprised 200 pregnant women. They were divided into two groups each are 100:

  • Group A: pregnant women diagnosed to have intrapartum fetal distress who will receive MgSO4.

  • Group B: pregnant women diagnosed to have intrapartum fetal distress who will receive placebo

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological changes according to NICE guidelines 2017) in any of the groups will receive the allocated treatment at least 20 minute before the procedure (emergency CS).

measures to reduce the effect of hypoxia will be applied to all participate through:

  • The position of the mother will be changed to left lateral position (allow increased blood supply).

  • I.V. fluid bolus (to avoid maternal dehydration).

  • Oxytocin or cervical ripening agent will be discontinued.

  • Fetal heart rate monitoring with cardiotocography will be attempted.

  • If umbilical cord prolapse is noted, elevate the presenting fetal part until preparing for emergency operative delivery.

  • After birth, Apgar score will be used to identify distress newborns that need resuscitation.

The study comprised 200 pregnant women. They were divided into two groups each are 100:

  • Group A: pregnant women diagnosed to have intrapartum fetal distress who will receive MgSO4.

  • Group B: pregnant women diagnosed to have intrapartum fetal distress who will receive placebo

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Magnesium Sulphate for Fetal Neuroprotection in Full Term Deliveries
Actual Study Start Date :
May 21, 2020
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: MgSO4 group

will receive a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose

Drug: MgSo4
a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose.
Other Names:
  • magnesium sulfate

    		•
    Placebo Comparator: placebo group

    will receive an equal volume of isotonic 0.9% saline over 15-20 minutes

    Drug: Isotonic saline
    equal volume of isotonic 0.9% saline over 15-20 minutes

    Outcome Measures

    Primary Outcome Measures

    1. Apgar score [1 minute after delivery]

      Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration between 0 and 10

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Pregnant women at least 37 week of gestation.

    • Not more than 35 years old.

    • Fetal distress (perinatal asphyxia) diagnosed by CTG changes (Non reassuring or pathological changes according to NICE guidelines 2017).

    • Clinical chorioamnionitis.

    • Prolonged rupture of membranes

    Exclusion Criteria:

    • Medical disorders such as chronic hypertension, preeclampsia, eclampsia, DM, pulmonary hypertension, hepatic coma with risk of renal failure, and any renal, cardiac or pulmonary disease.

    • RH -ve.

    • Consanguinity.

    • Preterm labor.

    • Fetal malpresentation.

    • Contraindications to the use of Magnesium Sulphate.

    • Any indication for magnesium Sulphate therapy (seizure prophylaxis or tocolysis).

    • Myasthenia gravis.

    • Congenital fetal anomalies.

    • Fetal growth restriction (birth weight < 10th Percentile for gestational age).

    • Advanced cervical dilation (8cm).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr Alainy medical school Cairo Egypt 12151

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed M Maged, MD, professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04401852
    Other Study ID Numbers:
    • 60
    First Posted:
    May 26, 2020
    Last Update Posted:
    Feb 9, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    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:
    Magnesium Sulfate

    Study Results

    No Results Posted as of Feb 9, 2021