Exporatory clinical study for preeclampsia with oral nicotinamide
- Conditions
- preeclampsia
- Registration Number
- JPRN-jRCTs021180005
- Lead Sponsor
- Sugawara Junichi
- Brief Summary
In this clinical study, the study medication was terminated and delivery occurred on the second day of administration due to worsening of the underlying disease caused by elevated blood pressure, without any effect of the study medication. Since only one patient was enrolled, the efficacy of the study drug could not be determined.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 1
1)preeclampsia;
diagnosed after preganancy 20wks with
BP>=140/90
Proteinuria: Proteinuria is diagnosed if any of the following:
1. 24-hour urine>=300 mg / day.
2. Spot urine: Protein / creatinine (P/C) ratio>= 0.3 mg / mg-CRE.
3. Proteinuria qualitative test: >= 1+ is detected twice or more consecutively by paper test using two or more spot urine.
2)clinical limitations;
chronic hypertension
renal dysfunction (creatinine>=1.5mg/dl)
vascular disease, SLE, DM
hepatitis
cerebrovascular disorder
3)clinical examination value;
AST, ALT<=105 IU/L
Creatinine<=1.5mg/dl
Platelet>=100,000
4)written informed consent
1)Past history of
Renal disease with creatinine concentration over 13.3mg/dl
Vascular disease (cardiovascular disease, lupus, diabetes mellitus)
Liver dysfunction (hepatitis B, C, HIV, INH use)
Brain damage(convulsion, brain edema, uncontrollable headache)
Lung edema
2)HELLP syndrome
3)Abnormal fetal heart rate monitoring pattern (Level 5, JSOG criteria)
4)Fetal growth<5th %tile, oligohydramnios5)Diagnosis of induced delivery by Biophysical Profile Scoring
6)Suspicious of placental abruption
7)Suspicious of eclampsia
8)Ongoing preterm delivery
9)Past history of allergy by Nicotinamide
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prolongation of gestational period
- Secondary Outcome Measures
Name Time Method Decrease of proteinuria, Increase of fetal growth, Decrease of feto-maternal complications