Phase
Condition
Pregnancy Complications
Circulation Disorders
Vascular Diseases
Treatment
Antihypertensive treatment
Clinical Study ID
Ages 14-49 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pregnant women
Gestational age: 23 weeks, 0 days to 35 weeks, 6 days
Hypertensive disorder of pregnancy including gestational hypertension orpreeclampsia, the non-severe form at enrollment, which is called without severefeatures by the American College of Obstetricians and Gynecologists.
No evidence of the severe form of preeclampsia, termed severe features, as outlinedin maternal exclusions
No indication for delivery at the time of enrollment.
Planned expectant management at time of enrollment
Singleton or dichorionic twin gestation, defined at and beyond 14 weeks gestation. (A pregnancy complicated by a vanishing twin in the first trimester defined as lessthan 14 weeks gestation will be eligible.)
Intact membranes
Exclusion
Exclusion Criteria:
Preeclampsia with severe features, defined per ACOG as:
Systolic blood pressure of 160 mm Hg or more, or diastolic blood pressure of 110 mmHg or more on two occasions at least 4 hours apart (unless antihypertensive therapyis initiated before this time)
Thrombocytopenia defined as: lower than 100 x 10e9 platelets/L
Impaired liver function that is not accounted for by alternative diagnoses and asindicated by abnormally elevated blood concentrations of liver enzymes (to more thantwice the upper limit normal concentrations), or by severe persistent right upperquadrant or epigastric pain unresponsive to medications
Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or adoubling of the serum creatinine concentration in the absence of other renaldisease)
Pulmonary edema
New-onset headache unresponsive to medication and not accounted for by alternativediagnoses
Visual disturbances
Underlying renal dysfunction defined as, presenting the following parameters priorto 20 weeks gestation: baseline creatinine, equal to or higher than, 1.2 mg/dL Orproteinuria: defined as presenting protein in urine, equal to or higher than, 300mg/24 hours or protein/creatinine ratio, equal to or higher than, 0.3 or Urinedipstick reading of greater than or equal to 2 at baseline and in the absence of aurinary tract infection
Stage 2 chronic hypertension
Contraindications to labetalol and nifedipine XL according to the FDA package insert
Patient unable to or unwilling to adhere to management recommendations
Fetal Reasons for Study Ineligibility:
Fetal growth restriction (lower than 10th percentile) at enrollment, based on anultrasound within 3 weeks prior to enrollment
Oligohydramnios defined by amniotic fluid deepest vertical pocket <2 cm based on anultrasound within the 48 hours prior to enrollment
Known major structural or chromosomal abnormality
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesActive - Recruiting
Oschner
New Orleans, Louisiana 70115
United StatesActive - Recruiting
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