Study of Nicotinamide in Early Onset Preeclampsia

Overview

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.

Full Title of Study: “Phase II Study of Nicotinamide in Early Onset Preeclampsia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2021

Detailed Description

See brief summary above

Interventions

  • Drug: nicotinamide
    • 2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday

Arms, Groups and Cohorts

  • Experimental: Nicotinamide
    • All participants will receive study agent

Clinical Trial Outcome Measures

Primary Measures

  • Change in Mean Arterial blood Pressure (MAP)
    • Time Frame: Baseline, 48 hours
    • Blood pressure (mmHg) will be used to observe the effect of nicotinamide. The highest MAP (defined as the highest MAP within the 24 hour period prior to the administration of study agent) and the highest MAP at 48 hours after study drug administration.

Secondary Measures

  • Number of participants with alanine aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN)
    • Time Frame: Within 24 hours of any dose
  • Number of participants with aspartate aminotransferase (AST) =/> 3x Upper Limit of Normal (ULN)
    • Time Frame: Within 24 hours of any dose
  • Number of participants with Maternal side effects
    • Time Frame: From initial administration of study agent until 24 hours post last dose
    • Maternal side effects are defined as: facial erythema, hives, sore mouth, dry hair, fatigue, flushing, headache, nausea, and heart burn.
  • Change in Mean Arterial blood Pressure (MAP)
    • Time Frame: Baseline, Day 7
    • Blood pressure (mmHg) will be used to observe the effect of nicotinamide. The highest MAP (defined as the highest MAP within the 24 hour period prior to the administration of study agent) and the highest MAP at 7 days after study drug administration.
  • Proportion of women maternal abdominal tenderness
    • Time Frame: From initial administration of study agent until 24 hours post last dose
  • Proportion of women with headache unrelieved by oral analgesics
    • Time Frame: From initial administration of study agent until 24 hours post last dose
  • Proportion of women with hematocrit decrease of more than 3%
    • Time Frame: From initial administration of study agent until 24 hours post last dose
  • Proportion of women with less than 500 cc urine output in 24 hours
    • Time Frame: From initial administration of study agent until 24 hours post last dose
  • Proportion of fetuses with Category III non stress test results
    • Time Frame: From initial administration of study agent until 24 hours post last dose
  • Proportion of fetuses with biophysical profile < 6
    • Time Frame: From initial administration of study agent until 24 hours post last dose

Participating in This Clinical Trial

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

Gender Eligibility: Female

Study of pregnant women only

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of North Carolina, Chapel Hill
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kim Boggess, MD, Principal Investigator, UNC_Chapel Hill
  • Overall Contact(s)
    • Karen Dorman, RN, 984-974-9012, kdorman@med.unc.edu

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