Premature BirthPhase 2/3NCT05674565
Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries
A Phase 2/3 study testing Magnesium sulfate loading with maintenance dose and Magnesium sulfate loading dose only in people with Premature Birth and NEUROPROTECTION, run by Zagazig University at 1 site in Egypt.
Trial summary
A Cochrane systematic review has confirmed that fetal exposure to magnesium sulphate given before preterm birth has a neuroprotective role. This review also showed a significant reduction in the rate of gross motor dysfunction in early childhood. Read more about this study
- Who is it for?
- Ages 24 to 34 weeks
- Conditions the study is for
- Premature Birth, NEUROPROTECTION, MAGNESIUM SULPHATE
- What is being tested?
- Magnesium sulfate loading with maintenance dose and Magnesium sulfate loading dose only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2023to 15 Jul 2024
- Phase
- Phase 2/3
- 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 24 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Women at risk of preterm birth who are between 24+0 and 33+6 weeks of gestation.
- 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
Who cannot join
- Women with known Hypersensitivity to magnesium
- Caution regarding dosage for patients with renal impairment
- Preterm delivery after 34 weeks
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine, Zagazig University
Zagazig, Sharqia Province, 44519
Hytham Atia, M.D., hythamatia@gmail.com
Amro El Nemr, M.D.
About this study
Official title: The Neuroprotective Impact of Magnesium Sulphate Therapy for Preterm Deliveries. Loading Dose Alone Strategy Versus Loading Plus Maintenance Dose Strategy.
A Cochrane systematic review has confirmed that fetal exposure to magnesium sulphate given before preterm birth has a neuroprotective role. This review also showed a significant reduction in the rate of gross motor dysfunction in early childhood. Early Preterm birth (< 34+0 weeks) and very low birthweight (< 1,500 g) are the principal risk factors for cerebral palsy. Multiple pregnancy accounts for over 10% of preterm births and has a higher incidence of cerebral palsy than singleton pregnancy (twins have 7 times and triplets 47 times the risk of cerebral palsy compared with singletons).
Read the detailed description
Many of these patients come or get diagnosed as eminent preterm delivery very soon before the real delivery happens and are not able to complete the recommended therapy of loading and maintenance strategy for at least complete 4 hours before delivery.
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.
- Being tested
- Magnesium sulfate loading with maintenance dose, Magnesium sulfate loading dose only
- Keywords
- CEREBRAL PALSY, PRETERM BIRTH, NEUROPROTECTION, NEONATAL DEATH, MAGNESIUM SULPHATE
- Medical subject headings
- Premature Birth, Cerebral Palsy, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfate loading with maintenance doseDrug
Also called complete therapy
4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery
Magnesium sulfate loading dose onlyDrug
Also called short therapy
4 gm MgSo4 loading over 20 minutes within one hour before delivery
| Study group | Role | What they receive |
|---|---|---|
| Loading dose only | Experimental | 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 Receives: Drug: Magnesium sulfate loading dose only |
| Loading plus maintenance dose | Experimental | 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. Receives: Drug: Magnesium sulfate loading with maintenance dose |
| Control | No intervention | comparable number of women who did not receive magnesium sulphate neuroprotection for any reason |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Neurological insult
The incidence of neurological insults during the first year of life (including cerebral palsy, brain leukomalacia, intraventricular hemorrhage, and neonatal seizures)
Measured: at 18 months age after delivery
Maternal toxicity
Risk of maternal magnesium sulphate toxicity (affected reflexes, respiratory and cardiac), postpartum hemorrhage.
Measured: from start of therapy, till 12 hours after end of therapy
Postpartum hemorrhage
Risk of primary postpartum hemorrhage
Measured: first 24 hours after delivery
Secondary outcomes (2)
Late appearing neurologic insults
Risk of gross motor delay, epilepsy, impaired fine motor skills, sensorineural (hearing and vision) impairment, and possibly two years of age developmental quotient.
Measured: at 24 months age after delivery
Neonatal death
Death within first 28 days after delivery
Measured: 28 days from birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start20 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Zagazig 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hytham Atia, Zagazig University
- Investigators
- Hytham Atia, M.D., Study chair, Zagazig UniversityAmro Alnemr, M.D., Principal investigator, Zagazig UniversityMohamed Lashin, M.D., Principal investigator, Zagazig UniversitySherief M El Gebaly, M.D., Principal investigator, Zagazig UniversityMohamed Arafa, M.D., Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674565
- Sponsor's protocol ID
- MGSULPH NEUROPROTECT EGYPT
- Status last verified
- Jul 2023
- First submitted
- 19 Nov 2022
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuroprotective Impact of Magnesium Sulphate Therapy for Preterm Deliveries. Loading Dose Alone Strategy Versus Loading Plus Maintenance Dose Strategy.
- ClinicalTrials.gov ID
- NCT05674565
- Acronym / sponsor ID
- MGSULPH NEUROPROTECT EGYPT
- Keywords
- CEREBRAL PALSY, PRETERM BIRTH, NEUROPROTECTION, NEONATAL DEATH, MAGNESIUM SULPHATE
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 6 Jan 2023 (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.
A Cochrane systematic review has confirmed that fetal exposure to magnesium sulphate given before preterm birth has a neuroprotective role. This review also showed a significant reduction in the rate of gross motor dysfunction in early childhood. Early Preterm birth (< 34+0 weeks) and very low birthweight (< 1,500 g) are the principal risk factors for cerebral palsy. Multiple pregnancy accounts for over 10% of preterm births and has a higher incidence of cerebral palsy than singleton pregnancy (twins have 7 times and triplets 47 times the risk of cerebral palsy compared with singletons).
Detailed description
Many of these patients come or get diagnosed as eminent preterm delivery very soon before the real delivery happens and are not able to complete the recommended therapy of loading and maintenance strategy for at least complete 4 hours before delivery.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Loading dose only | Experimental | Drug: Magnesium sulfate loading dose onlyThose receiving only the loading dose of magnesium sulphate 4 gm infusion over 20 minutes therapy within one hour before delivery without the maintenance dose |
| Loading plus maintenance dose | Experimental | Drug: Magnesium sulfate loading with maintenance doseReceiving 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. |
| Control | No intervention | –comparable number of women who did not receive magnesium sulphate neuroprotection for any reason |
Who may qualify
- Ages
- 24 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Women at risk of preterm birth who are between 24+0 and 33+6 weeks of gestation.
- When early preterm birth is planned or expected within 24 h, regardless of:
Key exclusion criteria (3 listed)
- Women with known Hypersensitivity to magnesium
- Caution regarding dosage for patients with renal impairment
- Preterm delivery after 34 weeks
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 |
|---|---|---|
| Magnesium sulfate loading with maintenance doseAlso: complete therapy4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery | Drug | Loading plus maintenance dose |
| Magnesium sulfate loading dose onlyAlso: short therapy4 gm MgSo4 loading over 20 minutes within one hour before delivery | Drug | Loading dose only |
Primary outcome
Neonatal Neurological insult
Time frame: at 18 months age after delivery
The incidence of neurological insults during the first year of life (including cerebral palsy, brain leukomalacia, intraventricular hemorrhage, and neonatal seizures)
Maternal toxicity
Time frame: from start of therapy, till 12 hours after end of therapy
Risk of maternal magnesium sulphate toxicity (affected reflexes, respiratory and cardiac), postpartum hemorrhage.
Postpartum hemorrhage
Time frame: first 24 hours after delivery
Risk of primary postpartum hemorrhage
2 secondary outcomes
Late appearing neurologic insults
Time frame: at 24 months age after delivery
Neonatal death
Time frame: 28 days from birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- BackgroundShennan 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.
- BackgroundUsman 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
- Individual participant dataSharing planned: No
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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.
Hytham Atia, M.D. study chair
Zagazig University
Amro Alnemr, M.D. principal investigator
Zagazig University
Mohamed Lashin, M.D. principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Magnesium sulfate loading with maintenance dose and Magnesium sulfate loading dose only in people with Premature Birth and NEUROPROTECTION, run by Zagazig 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 6 inclusion and 3 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 14 Jul 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hytham Atia, M.D (+9660538308500, hythamatia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Neurological insult (time frame: at 18 months age after delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05674565, which also lists 2 linked publications.
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 14 Jul 2023.