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Magnesium Sulfate for Fetal Neuroprotection

NCT04401852 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-02-09

No results posted yet for this study

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

Conditions

  • Fetal Neuroprotection

Interventions

DRUG

MgSo4

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

DRUG

Isotonic saline

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-21
Primary Completion
2021-08-31
Completion
2021-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04401852 on ClinicalTrials.gov