NCT04401852

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 21, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

May 21, 2020

Last Update Submit

February 5, 2021

Conditions

Fetal Neuroprotection

Outcome Measures

Primary Outcomes (1)

  • Apgar score

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

    1 minute after delivery

Study Arms (2)

MgSO4 group

ACTIVE COMPARATOR

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

Drug: MgSo4

placebo group

PLACEBO COMPARATOR

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

Drug: Isotonic saline

Interventions

MgSo4DRUG

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

Also known as: magnesium sulfate
MgSO4 group
Isotonic salineDRUG

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

placebo group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

RECRUITING

MeSH Terms

Interventions

Magnesium SulfateSodium Chloride

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Central Study Contacts

Ahmed maged

CONTACT

+201005227404ahmedmaged@cu.edu.eg

Wesam Deeb

CONTACT

wessamdeeb74@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 26, 2020

Study Start

May 21, 2020

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)