Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight
- Conditions
- Low Birth Weight Infants
- Registration Number
- NCT03187938
- Lead Sponsor
- TriHealth Inc.
- Brief Summary
Alkaline phosphatase is known to be produced by syncytiotrophoblasts in the placenta and its levels are normally increased in pregnancy. Therefore, it would be reasonable to hypothesize that alkaline phosphatase would be low to low normal in cases of low birth weight / intrauterine growth restriction (IUGR)/ placental insufficiency.
- Detailed Description
The purpose of this study will be to determine if alkaline phosphatase can be used as a predictor for suboptimal fetal growth, placental insufficiency and low birth weight (birth weight less than 2500 grams). It will also help determine if alkaline phosphatase can be used as a screening tool for low birth weight/IUGR at the time of the 24 to 28 week labs.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 292
• Patients enrolled between 24w0d and 28w6d weeks gestational age will be included. The blood specimen of the patients enrolled will be held until delivery.
- Multiple gestations
- Known congenital malformations (any, except Pyelectasis)
- Chronic hypertension
- Inflammatory bowel disease (IBD)
- Gall bladder disease
- Active bone disease (ie, skeletal dysplasia, healing fracture)
- Active liver disease (ie, hepatitis, cholestasis, cholelithiasis (gallstones))
- Pre-existing type 1 and 2 Diabetes
- Early-onset IUGR
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Birth Weight at Delivery At Delivery Birth Weight at Delivery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Good Samaritan TriHealth Hospital
🇺🇸Cincinnati, Ohio, United States
Good Samaritan TriHealth Hospital🇺🇸Cincinnati, Ohio, United States