Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight

Low Birth Weight Infants Clinical Trial

Official title:

Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187938
• Other study ID #: 16-095
• Status: Completed
• Start date: June 14, 2017
• Est. completion date: August 5, 2019

Study information

• Verified date: August 2019
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: August 5, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Low Birth Weight Infants

Intervention

Diagnostic Test:
• Testing of Alkaline Phosphatase Levels
Testing of alkaline phosphatase levels at the time of the 24w0d to 28w6d week labs.

Locations

Country	Name	City	State
United States	Good Samaritan TriHealth Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth Weight at Delivery	Birth Weight at Delivery	At Delivery