Calcium Channel Blockers Compared to Magnesium Sulfate in Fetal Cerebral Blood Flow
Condition: Preterm Labor; Cerebral Palsy
MeSH terms: Cerebral Palsy; Premature Birth; Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to investigate the possible use of calcium channel as a
      neuroprotectant in cases with PTL. This will be done by comparing the effect they have on
      cerebral blood vessels with the already established MgSo4. They have been proven superior to
      magnesium sulphate in tocolysis, and they possess the mechanism of action that would allow
      for their theoretical use as neuroprotective agents.
    

Detailed description: 
      After internal review board approval from the obstetrics and gynecology department of Kasr
      Alainy hospital, 130 patients will be recruited in a randomized case control study. The
      patients will be recruited from the emergency admissions department, after fulfilling the
      recruitment criteria. In an independent case-control study the Sample size was calculated
      using an odds ratio of exposure to CP of 0.14 (95% CI 0.05-0.51) (Grether et.al, 1998), where
      the alpha level error was fixed at 0.5 and the power was set at 80%, the optimal sample size
      was calculated to be 65 patients in each arm.

      Patients will be randomized on admission by nurse in labor ward into either one of two
      groups. Group A will receive MgSo4, while group B will receive Nifedipine ( Epilat 20mg ®
      EIPICO Egypt ). Randomization will be achieved through a computer generated randomization
      table. Recruitment will continue till 65 patients will be allocated to each group.

      Patients in group A will receive 4 gm intravenous (I.V) MgSo4 loading dose over 30 mins & 1
      gm/ hour maintenance dose for 24 hours, or till labor occurs ( whichever occurs first) , this
      does is given in accordance with Australian Research Centre for Health of Women and Babies,
      2010, for using MgSo4 for neuroprotection against CP.

      While patients in group B will receive Nifedipine ( Epilat 10mg ® EIPICO Egypt ), as there is
      no recommended dose for the use of nifedipine as neuroprotectant, the dose given in this
      study will be same as that used for tocolysis. Nifedipine wil be given in a loading dose of
      40 mg in the 1st hour (10mg will be given every 15 min), then a maintenance dose of 60mg /24
      hours, divided in 3 doses (Hösli et.al, 2014).

      The ability of the MgSo4 as a neuro protectant is dependent on its cerebral vasodilating
      effects (Magee et.al,2011; Macdonald et.al, 2004), therefore we propose to measure the mean
      pulsility index (PI) and resistance index (PI) of the middle cerebral artery in the fetus
      twice, once before giving them the drug, and the other after 4 hours of starting the loading
      dose. All ultrasound and power doppler examinations will be carried out by the same
      investigator, using the Voluson 730 machine (GE Healthcare Austria GmbH, Seoul, Korea).
      Sample size calculation was done using Stats Direct statistical software version 2.7.2 for MS
      Windows, StatsDirect Ltd., Cheshire, UK.
    

Intervention name(s): Magesium sulphate; Nifedipine; Doppler on fetal middle cerebral artery
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): *Experimental: Group A: Magesium sulphate 4 gm intravenous (I.V) loading dose over 30 mins & 1 gm/ hour maintenance dose for 24 hours, or till labor occurs ( whichever occurs first); *Active Comparator: Group B Nifedipine wil be given in a loading dose of 40 mg in the 1st hour (10mg will be given every 15 min), then a maintenance dose of 60mg /24 hours, divided in 3 doses; both group A and group B: ultrasound doppler to measure the mean pulsility index (PI) and resistance index (PI) of the middle cerebral artery in the fetus twice, once before giving them the drug, and the other after 4 hours of starting the loading dose.
Other intervention name(s): MgSo4; Epilat
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neuroprotection; calcium channel blockers; magnesium sulhate; Middle cerebral artery doppler