Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight

Completed

• Conditions: Low Birth Weight Infants
• Interventions: Diagnostic Test: Testing of Alkaline Phosphatase Levels

• 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.

Study Timeline

• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-13
• Study Start: 2017-06-14
• Study First Posted: 2017-06-15
• Status Verified: 2019-08
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-05
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 292

Inclusion Criteria

• Patients enrolled between 24w0d and 28w6d weeks gestational age will be included. The blood specimen of the patients enrolled will be held until delivery.

Exclusion Criteria

• 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

Arm && Interventions

Group	Intervention	Description
Pregnant women at 24-28 weeks gestation	Testing of Alkaline Phosphatase Levels	Pregnant women, aged 18 and older, who are seen for their prenatal care and who are between 24w0d and 28w6d weeks gestation.Their alkaline phosphatase levels will be tested in this study.

Primary Outcome Measures

Name	Time	Method
Birth Weight at Delivery	At Delivery	Birth Weight at Delivery

Trial Locations

Locations (1)

Good Samaritan TriHealth Hospital; 🇺🇸 Cincinnati, Ohio, United States