An interventional study of Nifedipine in Pre-Eclampsia, Pregnancy and Hypertension, sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. Completed at 1 site in Canada. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-11-12.
Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Not applicable, Interventional, and Treatment
Preeclampsia is associated with significant maternal and fetal morbidity and mortality. Early identification and subsequent management of patients at risk of developing preeclampsia presents an ongoing challenge in prenatal care. Some at risk pregnancies may be identified from:
Early identification and effective treatment of patients would permit the safe completion of the pregnancy for the mother and infant. Recent advances in non-invasive cardiovascular monitoring have enabled the study of maternal hemodynamics in normal and at-risk pregnancies. This study hopes to identify the earliest significant changes in maternal hemodynamics which may allow targeted therapeutic interventions in patients at high risk of developing preeclampsia.
The hypothesis of this study is that systemic vascular resistance rises during the pre-clinical phase of preeclampsia and this can be captured using non invasive bioreactance technology. Treatment of the abnormally high vascular tone may decrease the severity and postpone the onset of clinical disease.
Invasive hemodynamic techniques have long identified significant increases in heart rate (HR), blood volume, left ventricular end-diastolic volume (LVEDV), stroke volume (SV) and cardiac output (CO) during the first and second trimesters of pregnancy. In normal pregnancy, CO increases from as early as 5 weeks gestation, with a 30-40% increase by the end of the first trimester of pregnancy. Cardiac output continues to rise throughout the second trimester until it reaches a level approximately 50% greater than that of non-pregnant women. Cardiac output slightly decreases during the third trimester. Despite these changes, maternal blood pressure (BP) still falls due to a large reduction in systemic vascular resistance (SVR) from systemic vasodilatation and the formation of a low-resistance utero-placental circulation. Systemic vascular resistance falls during early gestation, reaching its nadir (35% decline) at 20 weeks gestation, and rises during late pregnancy.
Transthoracic bioreactance is a newer technique of non-invasive continuous cardiac output monitoring. It is based on an analysis of relative phase shifts of oscillating currents that occur when this current traverses the thoracic cavity, as opposed to the traditional bioimpedance-based system, which rely only on measured changes in signal amplitude. Unlike bioimpedance, bioreactance-based non-invasive CO measurement does not use the static impedance and does not depend on the distance between the electrodes for the calculations of SV and CO, which significantly reduces the uncertainty in the result. Moreover, its readings were shown to correlate well with results derived from pulmonary artery catheter derived measurement of cardiac output. In addition, it has also been shown that the non-invasive cardiac output measurement (NICOM®) system has acceptable accuracy, precision and responsiveness for CO monitoring in patients experiencing a wide range of circulatory situations and has recently been used in the obstetric population.
The purpose of this study is to use non-invasive cardiac output monitoring to capture the earliest inappropriate rise in SVR during the pre clinical phase of disease, in patients at high risk of developing preeclampsia, as predicted by the placenta profile. In case an increase in SVR is identified, the purpose of this study is to implement a goal-directed therapy in an attempt to decrease the severity, and postpone the onset of clinical disease.
The hypothesis of this study is that the increases in SVR detected during the pre-clinical phase of preeclampsia can be treated with a goal directed therapy without fetal compromise and that this intervention may improve maternal and fetal/neonatal outcome.
903 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.
This study's enrollment of 20 is below the median of 110 across 478 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Samuel Lunenfeld Research Institute, Mount Sinai Hospital is the lead sponsor of 137 studies on the registry; 18 are open to participants now.
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Abnormal placental biochemistry Abnormal placental shape Abnormal placental texture
Exclusion Criteria:
Vasodilator therapy begins when SVR increases by 20% or greater than baseline. Therapy is titrated according to hemodynamic profile and clinical signs and symptoms.
Drug: Nifedipine
30-60 mg, twice daily
Also known as: Adalat XL
Systemic vascular resistance
Systemic vascular resistance is measured at the above time points, and more frequently at the discretion of the attending obstetrician.
Time frame: 20-22, 24-26, 28, 30-32 and 36 weeks gestational age
Maximum change in maternal blood pressure
Blood pressure is taken on the NICOM at the above time points, and more frequently at obstetric appointments in between.
Time frame: 20-22, 24-26, 28, 30-32 and 36 weeks gestational age
Gestational age at delivery
Time frame: 25-41 weeks gestational age
Fetal weight at delivery
Time frame: 25-41 weeks gestational age
Gestational age at time of first hospitalization
Time frame: 25-41 weeks gestational age
Gestational age at peak maternal blood pressure
Time frame: 20-41 weeks
Gestational age at which steroids are administered
Time frame: 25-41 weeks gestational age
Serum s-Flt and PlGF levels
Time frame: 12-41 weeks gestational age
The record gives a start of Dec 2010, a primary completion of Nov 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nifedipine
Samuel Lunenfeld Research Institute, Mount Sinai Hospital →