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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Control | No Intervention | comparable number of women who did not receive magnesium sulphate neuroprotection for any reason |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulfate loading with maintenance dose | Drug | 4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Neurological insult | The incidence of neurological insults during the first year of life (including cerebral palsy, brain leukomalacia, intraventricular hemorrhage, and neonatal seizures) | at 18 months age after delivery |
| Maternal toxicity | Risk of maternal magnesium sulphate toxicity (affected reflexes, respiratory and cardiac), postpartum hemorrhage. | from start of therapy, till 12 hours after end of therapy |
| Postpartum hemorrhage | Risk of primary postpartum hemorrhage | first 24 hours after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 24 months age after delivery |
| Neonatal death |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hytham Atia, M.D | Contact | +9660538308500 | hythamatia@gmail.com | |
| Amro Alnemr, M.D. | Contact | +201224581528 | amrabmohsen@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Hytham Atia, M.D. | Zagazig University | Study Chair |
| Amro Alnemr, M.D. | Zagazig University | Principal Investigator |
| Mohamed Lashin, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Zagazig University | Recruiting | Zagazig | Sharqia Province | 44519 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| Background | 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 |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D002547 | Cerebral Palsy |
| D066087 | Perinatal Death |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D012780 | Short-Wave Therapy |
| ID | Term |
|---|---|
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D000078702 | Radiofrequency Therapy |
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|
| Magnesium sulfate loading dose only | Drug | 4 gm MgSo4 loading over 20 minutes within one hour before delivery |
|
|
Death within first 28 days after delivery
| 28 days from birth |
| Zagazig University |
| Principal Investigator |
| Sherief M El Gebaly, M.D. | Zagazig University | Principal Investigator |
| Mohamed Arafa, M.D. | Zagazig University | Principal Investigator |
| D000091642 | Urogenital Diseases |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |