Fetal NeuroprotectionNCT04401852
Magnesium Sulfate for Fetal Neuroprotection
A study testing MgSo4 and Isotonic saline in people with Fetal Neuroprotection, run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fetal Neuroprotection
- What is being tested?
- MgSo4 and Isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 21 May 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Wesam Deeb contact
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12151
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
Official title: Magnesium Sulphate for Fetal Neuroprotection in Full Term Deliveries
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:
Read more
- 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
Read the 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
- Conditions
- Fetal Neuroprotection
- Being tested
- MgSo4, Isotonic saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MgSo4Drug
Also called magnesium sulfate
a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose.
Isotonic salineDrug
equal volume of isotonic 0.9% saline over 15-20 minutes
| Study group | Role | What they receive |
|---|---|---|
| MgSO4 group | Active comparator | will receive a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose Receives: Drug: MgSo4 |
| placebo group | Placebo comparator | will receive an equal volume of isotonic 0.9% saline over 15-20 minutes Receives: Drug: Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apgar score
Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration between 0 and 10
Measured: 1 minute after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start21 May 2020
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal NeuroprotectionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401852
- Sponsor's protocol ID
- 60
- Status last verified
- Feb 2021
- First submitted
- 21 May 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulphate for Fetal Neuroprotection in Full Term Deliveries
- ClinicalTrials.gov ID
- NCT04401852
- Acronym / sponsor ID
- 60
- Conditions
- Fetal Neuroprotection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MgSO4 group | Active comparator | Drug: MgSo4will receive a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose |
| placebo group | Placebo comparator | Drug: Isotonic salinewill receive an equal volume of isotonic 0.9% saline over 15-20 minutes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MgSo4Also: magnesium sulfatea single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose. | Drug | MgSO4 group |
| Isotonic salineequal volume of isotonic 0.9% saline over 15-20 minutes | Drug | placebo group |
Primary outcome
Apgar score
Time frame: 1 minute after delivery
Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration between 0 and 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Fetal Neuroprotection
RecruitingPhase 1
Neonatal White Matter Injury Trial (WRAP)
White Matter Injury, Brain Injury, Fetus and Neonate
RecruitingPhase 3
Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
Fetal Growth Retardation, Stillbirth and Fetal Death
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wesam Deeb contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MgSo4 and Isotonic saline in people with Fetal Neuroprotection, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed maged (+201005227404, ahmedmaged@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apgar score (time frame: 1 minute after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.