Magnesium Sulfate for Fetal Neuroprotection
Кључне речи
Апстрактан
Опис
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
Датуми
Последња верификација: | 04/30/2020 |
Фирст Субмиттед: | 05/20/2020 |
Предвиђена пријава послата: | 05/21/2020 |
Прво објављено: | 05/25/2020 |
Послато последње ажурирање: | 05/21/2020 |
Последње ажурирање објављено: | 05/25/2020 |
Стварни датум почетка студије: | 04/30/2020 |
Процењени датум примарног завршетка: | 07/31/2020 |
Предвиђени датум завршетка студије: | 08/31/2020 |
Стање или болест
Интервенција / лечење
Drug: MgSO4 group
Drug: placebo group
Фаза
Групе руку
Арм | Интервенција / лечење |
---|---|
Active Comparator: MgSO4 group will receive a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose | Drug: MgSO4 group a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose. |
Placebo Comparator: placebo group will receive an equal volume of isotonic 0.9% saline over 15-20 minutes | Drug: placebo group equal volume of isotonic 0.9% saline over 15-20 minutes |
Критеријуми
Узраст подобан за студирање | 18 Years До 18 Years |
Полови подобни за студирање | Female |
Прихвата здраве волонтере | да |
Критеријуми | Inclusion Criteria: - 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 Exclusion Criteria: - 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). |
Исход
Примарне мере исхода
1. Apgar score [1 minute after delivery]