Antenatal Magnesium Sulphate in High-Risk Preterm Patients

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for pregnant women at high risk of early birth, between 32 and 35 weeks of pregnancy. It tests whether magnesium sulphate before birth lowers the baby's risk of cerebral palsy.

Életkor

18 Years to 45 Years

Nem

Women only

A betegség stádiuma

Pregnant with one baby, between 32 and 35 weeks, with birth planned or expected within 24 hours.

Korábbi kezelés

Must not have had magnesium sulphate before birth in this pregnancy for high blood pressure or preeclampsia.

A részvétel fő kizáró okai

• Pregnant with more than one baby
• Needs magnesium sulphate to treat preeclampsia
• Already in the pushing stage of labour (second stage)
• Breathing under 16 breaths per minute, no knee reflexes, or urine under 100 mL in the previous 4 hours
• Kidney failure, low blood calcium (hypocalcemia) or myasthenia gravis

Ez a vizsgálat csak várandós résztvevőket keres. A regiszter mondata, amelyen ez alapul: Pregnant women at high risk of preterm birth between 32 and 35 weeks of gestation

A regiszter feltételei, szó szerint

Nézd meg, megfelelhetsz-e

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• 18 és 45 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

The goal of this clinical trial is to evaluate whether antenatal magnesium sulphate reduces the risk of cerebral palsy in infants born to women at high risk of preterm birth. It will also assess the safety of magnesium sulfate for both the mother and the neonate. The main question it aims to answer is whether magnesium sulphate given before anticipated preterm delivery decreases the incidence of cerebral palsy without causing significant maternal or neonatal adverse effects. Researchers will compare magnesium sulphate with a placebo in women at high risk of preterm birth between 32 and 35 weeks of gestation. Participants will be randomly assigned to receive either intravenous magnesium sulphate or a placebo before delivery, and maternal and neonatal outcomes will be followed after birth, including neurodevelopmental assessment of the infant.

A vizsgálat 2 csoportja

• Magnesium SulphateA vizsgált kezelés

  Participants in this arm will receive intravenous magnesium sulfate for fetal neuroprotection, given as a 4 g loading dose (8 mL) over 20 minutes followed by a maintenance infusion of 1 g/hour (2 mL/hour) until delivery or for up to 24 hours.

  Kezelés: Magnesium sulfate

• PlaceboPlacebo, összehasonlításként

  Participants in this arm will receive placebo as isotonic sodium chloride 0.9%, given intravenously as 8 mL over 20 minutes followed by a maintenance infusion of 2 mL/hour until delivery or for up to 24 hours, using the same schedule as the active treatment arm.