Study of Nicotinamide in Early Onset Preeclampsia
Study of Nicotinamide in Early Onset Preeclampsia
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.
See brief summary above
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:

 -  Early-onset: between 24 weeks 0 days and -33 weeks 3 days, based on menstrual
 dating confirmed by first or second trimester ultrasound OR second trimester
 ultrasound if menstrual dating unavailable;

 -  Preeclampsia:

 -  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

 -  Candidate for expectant management for at least 48 hours

 -  Deemed clinically stable by primary clinician and candidate for expectant
 management (delayed delivery) for at least 48 hours;

 -  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

 -  Pre-existing renal disease (creatinine > 1.5 mg/dL)

 -  Any pre-existing medical condition that would increase risk for liver toxicity (e.g.
 hepatitis B or C; HIV; Isoniazid (INH) use)

 -  Eclampsia; cerebral edema on CT/MRI; headache unrelieved by analgesics

 -  Evidence of liver dysfunction (LFTs > 2x ULN)

 -  Thrombocytopenia (platelets < 100,000 mm³)

 -  Pulmonary edema

 -  HELLP syndrome

 -  Evidence of fetal compromise: Estimated Fetal Weight (EFW) < 5th percentile; or BPP <
 6; or absent or reverse diastolic UA blood flow; or oligohydramnios (MVP < 2 cm)

 -  Placental abruption defined as unexplained vaginal bleeding

 -  Preterm labor defined as regular contractions and cervical change

 -  Any condition deemed by the investigator to be a risk to mother or fetus in completion
 of the study

 -  Any condition deemed by the investigator to require delivery within 48 hours