Nifedipine Dosing Daily vs Twice a Day for Pre-eclampsia With Severe Features (NOPPI)
Condition: Preeclampsia With Severe Features
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Observational

Summary: 
      The investigators propose a randomized controlled unblinded trial to evaluate rates of
      optimal blood pressure control between Nifedipine 60mg XL once daily vs. Nifedipine 30mg XL
      twice daily in patients admitted for expectant management with pre-eclampsia with severe
      features. Patients will be approached for consent when they are placed on 30mg of Nifedipine
      daily by their primary provider and will be enrolled in the study when the primary provider
      has made the decision to increase the patient's daily dose of Nifedipine XL from 30mg to
      60mg.
    

Detailed description: 
      This is a randomized controlled unblinded trial at The Ohio State University comparing
      Nifedipine XL 60mg daily to 30mg twice daily in patients admitted for expectant management
      for pre-eclampsia with severe features.

      Potential study participants will be identified at the time of admission to the antepartum
      unit. Inclusion criteria must be met, namely patient's age, gestational age, diagnosis of
      preeclampsia with severe features.

      Patients will be approached for consent when they are placed on 30mg of Nifedipine daily by
      their primary provider and will be enrolled in the study when the primary provider has made
      the decision to increase the patient's daily dose of Nifedipine XL from 30mg to 60mg.
      Participants will be randomized in to one of two groups:

        -  Once daily Nifedipine XL 60mg Vs.

        -  Twice daily Nifedipine XL 30mg

      Once enrolled and randomized, blood pressures will be monitored every 4 hours as is standard
      on the antepartum unit. Blood pressures for the primary outcome will be collected 24 hours
      after the patient is randomized and initiated on their above regimen. This is to allow the
      medication to reach steady state prior to collected information on optimal blood pressures.
      The primary outcome will consist of blood pressure values collected q4 hours beginning
      24h-48h after receiving their first dose of the randomized dose regimen.

      Algorithms for the administration of intravenous labetalol, Nifedipine or hydralazine will be
      utilized by the primary provider at his or her discretion.

      Women may take the medication concurrently with intravenous labetalol, hydralazine, or
      immediate release Nifedipine for the treatment of severe blood pressures as determined by
      their primary provider.

      All other obstetric care will be at the discretion of the primary provider, including but not
      limited to addition of second long-acting hypertensive agents, decision to proceed with
      delivery, IV magnesium for seizure prophylaxis and recommendations regarding mode of
      delivery. Data will be collected on these components of routine obstetric care. Analysis will
      be by intent to treat.

      A subset of patients will be enrolled for a pharmacokinetic study and blood will be collected
      at prespecified times following administration of the randomized Nifedipine XL regimen.
    

Intervention name(s): Nifedipine XL
Intervention type(s): Drug
Intervention description(s): Patients will be enrolled when the primary provider has made the decision to increase the patient's daily dose of Procardia XL from 30mg to 60mg. Participants will be randomized in to one of two groups
Once daily Nifedipine XL 60mg Vs.
Twice daily Nifedipine XL 30mg
Other intervention name(s): Procardia XL
Intervention MeSH terms: Nifedipine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women undergoing expectant management for a diagnosis of preeclampsia with severe
        features already initiated on 30mg Nifedipine XL and the primary provider has made the
        decision to increase the patient's daily dose of Procardia XL from 30mg to 60mg. .
      
Keywords: preeclampsia severe; Nifedipine XL 60mg; Nifedipine XL 30mg