Study of Nicotinamide in 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