Study of Nicotinamide in Early Onset Preeclampsia

• Status: Completed
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Niacin; Niacinamide; Nicotinic Acids

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:

• 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