Response to Anti-hypertensives in Pregnant and Postpartum Patients
Condition: Hypertension in Pregnancy; Preeclampsia
MeSH terms: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the investigators will evaluate the blood pressure response to nifedipine and
      labetalol in pregnant and postpartum patients, who present with hypertensive disease in
      pregnancy with severe range blood pressure defined as greater than 160/110. These
      anti-hypertensives are first line therapy for management of severe range blood pressures in
      pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG).
      In addition at the Mount Sinai West site, the investigators will also analyze the ADRB1 and
      similar genes involved in beta blockade, genes involved in calcium channel blockade and other
      genes implicated in blood pressure response among pregnant and postpartum patients receiving
      labetalol and nifedipine. This analysis will be used to determine if a pharmacogenetic
      association exists between variant alleles in these receptors in the pregnant and postpartum
      population.
    

Detailed description: 
      Hypertensive disease in pregnancy is a major cause of maternal morbidity and mortality. This
      condition is responsible for about 12% of the maternal deaths in the United States.

      Currently, if pregnant patients present with severe hypertension they are either given IV
      labetalol, IV hydralazine of nifedipine based on individual provider preference. There are
      few studies in the literature comparing oral nifedipine and IV labetalol with mixed data
      showing either they are equally effective or a faster time to achieving target blood pressure
      for patients who received nifedipine.

      In this study, the investigators will evaluate if there is a difference in time to achieve
      goal blood pressure in pregnant and postpartum patients who are treated with nifedipine and
      labetalol for severe range blood pressures defined as greater than 160/110. These
      anti-hypertensives are first line therapy for management of severe range blood pressures in
      pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG).
    

Intervention name(s): Nifedipine; Labetalol
Intervention type(s): Drug; Drug
Intervention description(s): Nifedipine 10mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given and institution specific protocol will be performed.; Labetalol 20mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication will be chosen based on institution specific protocol.
Intervention MeSH terms: Labetalol; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients who present to the hospitals in this study will be randomized to receive IV labetalol or oral nifedipine when presenting with persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic. These anti-hypertensives are first line therapy for management of severe range blood pressures by the American Congress of Obstetricians and Gynecologists.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension, Pregnancy-induced; Pregnancy Induced Hypertension; Gestational Hypertension; Transient Hypertension, Pregnancy; Pharmacogenetics