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About
Phase II Study of 2.5 gm of nicotinamide, given daily in 3 divided doses, to measure effect on maternal blood pressure in women with early onset preeclampsia and to determine peak and trough levels of nicotinamide. We will compare peak and trough levels in healthy non-pregnant and healthy pregnant participants.
Full description
See brief summary above
Enrollment
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Inclusion and exclusion criteria
Diagnosis and Inclusion Criteria
Maternal age 18-55 years
Singleton pregnancy with no known fetal anomalies
Early-onset preeclampsia OR early-onset severe gestational hypertension defined as:
New onset hypertension and proteinuria, with systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg on two occasions 6 hours apart and > 300 mg proteinuria on 24 hour urine collection OR urine P/C ratio >0.3;
New onset hypertension and NO proteinuria, with systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg on two occasions 6 hours apart and one or more of the following: serum creatinine >1.1 mg/dL or doubling from baseline ,or central nervous system symptoms or visual changes
Severe preeclampsia defined as new onset systolic BP > 160 mm Hg and/or diastolic BP > 105 with proteinuria as above or or without proteinuria and one or more of the following criteria listed above
Maternal liver function tests < 2x ULN
Maternal platelet count > 100,000 mm³
Planned expectant management
Pre-existing medical diseases such as hypertension, diabetes, endocrine disorders, gastrointestinal diseases, are well controlled
Fetal well-being established by estimated fetal weight > 5th %tile; normal amniotic fluid volume (MVP > 2 cm); normal Umbilical Artery (UA) Dopplers; or reactive Non Stress Test (NST) or Biophysical Profile (BPP) > 6
Delivery not anticipated within 48 hours of enrollment
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
23 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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