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Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight

ClinicalTrials.gov ID NCT03187938
Sponsor TriHealth Inc.
Information provided by TriHealth Inc. (Responsible Party)
Last Update Posted 2019-08-28
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Study Overview

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.
Official Title
Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight
Conditions
Low Birth Weight Infants
Intervention / Treatment
  • Diagnostic Test: Testing of Alkaline Phosphatase Levels
  • Diagnostic Test: Testing of Alkaline Phosphatase Levels
Other Study ID Numbers
  • 16-095
Study Start (Actual)
2017-06-14
Primary Completion (Actual)
2019-08-05
Study Completion (Actual)
2019-08-05
Enrollment (Actual)
292
Study Type
Observational

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United States
Ohio Locations
Cincinnati, Ohio, United States, 45220

Good Samaritan TriHealth Hospital
Click to view interactive map

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.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
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
Show less
Study Population
Pregnant women, aged 18 and older, who are seen for their prenatal care and who are between 24w0d and 28w6d weeks gestation.
Gender-based Eligibility
Yes
Gender Eligibility for Study
Pregnant women, aged 18 and older, who are seen for their prenatal care and who are between 24w0d and 28w6d weeks gestation.
Ages Eligible for Study
18 Years and older (AdultOlder Adult )
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample

Study Plan

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

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Design Details
Observational Model : Cohort
Time Perspective: Prospective

Groups and Interventions

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

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Birth Weight at DeliveryBirth Weight at DeliveryAt Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
TriHealth Inc.
Investigators
  • Principal Investigator:Donna Lambers, MD,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 Registration Dates
First Submitted
2017-06-13
First Submitted that Met QC Criteria
2017-06-13
First Posted
2017-06-15
Study Record Updates
Last Update Submitted that met QC Criteria
2019-08-26
Last Update Posted
2019-08-28
Last Verified
2019-08

More Information

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Keywords Provided by TriHealth Inc.
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No