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OpenTrials
Completed

NCT Number: NCT03187938

Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight

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.

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Key information

Conditions

Low Birth Weight Infants Female Urogenital Diseases and Pregnancy Complications Placenta Diseases Placental Insufficiency Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Good Samaritan TriHealth Hospital

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testing of Alkaline Phosphatase Levels

Diagnostic Test

Testing of alkaline phosphatase levels at the time of the 24w0d to 28w6d week labs.

Primary outcomes

  1. Birth Weight at Delivery

    Time frame: At Delivery

    Birth Weight at Delivery

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2017
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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