Status:
COMPLETED
Phase I Study of Nicotinamide for Early Onset Preeclampsia
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
North Carolina Translational and Clinical Sciences Institute
Conditions:
Pregnancy Induced Hypertension
Superimposed Preeclampsia
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
This is a Phase I study of vitamin B3-amide (nicotinamide) dietary supplementation in pregnant women with early onset preeclampsia. The investigators will enroll 10 pregnant women at 24-32 weeks' gest...
Eligibility Criteria
Inclusion
- Maternal age 18-45 years
- Informed written consent
- Preeclampsia or new onset hypertension between 24-32 completed weeks' gestation
- Hypertensive complications of pregnancy defined as new onset systolic BP \> 140 mm Hg and/or diastolic BP \> 90 mm Hg on two occasions 6 hours apart; OR \> 300 mg proteinuria on 24 hour urine collection OR urine P/C ratio \>0.3;
- Dating criteria based on menstrual dating confirmed by first or second trimester ultrasound OR second trimester ultrasound if menstrual dating unavailable;
- Deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery);
- Maternal liver function tests \< 3x ULN
- Maternal platelet count \> 100,000 mm3
- Fetal well-being established by estimated fetal weight \> 5th %tile; normal amniotic fluid volume (MVP \> 2 cm); normal Umbilical Artery Dopplers; AND reactive NST(non-stress test) or BPP (biophysical profile) \> 6
- Plan for expectant management until delivery
- Delivery not anticipated within first 48 hours
Exclusion
- Preeclampsia \< 24 or \> 33 weeks' gestation;
- Suspected fetal structural or chromosomal abnormality;
- Pre-existing renal disease (creatinine \> 1.5 mg/dL)
- Pre-existing vascular disease (systemic lupus; cardiac disease;)
- Plan for delivery within 48 hours
- Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV)
- Evidence of cerebral dysfunction (seizures; cerebral edema on CT/MRI; headache unresolved with oral analgesics)
- Pulmonary edema
- HELLP (hemolysis, elevated liver enzymes, low platelets syndrome)
- Evidence of liver dysfunction (LFTs \> 3x ULN)
- Thrombocytopenia (platelets \< 100,000 mm3)
- Evidence of fetal compromise: EFW(estimated fetal weight) \< 5th percentile; BPP \< 6; absent or reverse diastolic UA blood flow; 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
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02213094
Start Date
January 1 2014
End Date
December 3 2015
Last Update
November 2 2018
Active Locations (1)
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1
University of North Carolina Women's Hospital
Chapel Hill, North Carolina, United States, 27599-7516