Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight

August 26, 2019 updated by: TriHealth Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

292

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan TriHealth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women, aged 18 and older, who are seen for their prenatal care and who are between 24w0d and 28w6d weeks gestation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women at 24-28 weeks gestation
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.
Diagnostic test: Testing of Alkaline Phosphatase Levels
Testing of alkaline phosphatase levels at the time of the 24w0d to 28w6d week labs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth Weight at Delivery
Time Frame: At Delivery
Birth Weight at Delivery
At Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2017

Primary Completion (Actual)

August 5, 2019

Study Completion (Actual)

August 5, 2019

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 15, 2017

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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