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Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight

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ClinicalTrials.gov Identifier: NCT03187938
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Low Birth Weight Infants Diagnostic Test: Testing of Alkaline Phosphatase Levels

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
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Birth Weight at Delivery [ Time Frame: At Delivery ]
    Birth Weight at Delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women, aged 18 and older, who are seen for their prenatal care and who are between 24w0d and 28w6d weeks gestation.
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187938


Contacts
Contact: Ganga Devaiah, MS 513-862-2341 ganga_devaiah@trihealth.com
Contact: Pam Plummer, MSN, RN 513-862-6918 pam_plummer@trihealth.com

Locations
United States, Ohio
Good Samaritan TriHealth Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Ganga Devaiah, MS    513-862-2341    ganga_devaiah@trihealth.com   
Contact: Pam Plummer, MSN, RN    513-862-6918    pam_plummer@trihealth.com   
Sponsors and Collaborators
TriHealth Inc.
Investigators
Principal Investigator: Donna Lambers, MD TriHealth Inc.

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT03187938     History of Changes
Other Study ID Numbers: 16-095
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by TriHealth Inc.:
Alkaline Phosphatase
Pregnancy
Suboptimal fetal growth
Placental insufficiency
Low birth weight
IUGR

Additional relevant MeSH terms:
Body Weight
Birth Weight
Signs and Symptoms