NCT03187938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 14, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2.1 years

First QC Date

June 13, 2017

Last Update Submit

August 26, 2019

Conditions

Low Birth Weight Infants

Keywords

Alkaline PhosphatasePregnancySuboptimal fetal growthPlacental insufficiencyLow birth weightIUGR

Outcome Measures

Primary Outcomes (1)

  • Birth Weight at Delivery

    Birth Weight at Delivery

    At Delivery

Study Arms (1)

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

Interventions

Testing of Alkaline Phosphatase LevelsDIAGNOSTIC_TEST

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

Pregnant women at 24-28 weeks gestation

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women, aged 18 and older, who are seen for their prenatal care and who are between 24w0d and 28w6d weeks gestation.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients enrolled between 24w0d and 28w6d weeks gestational age will be included. The blood specimen of the patients enrolled will be held until delivery.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan TriHealth Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Placental Insufficiency

Condition Hierarchy (Ancestors)

Placenta DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Donna Lambers, MD

    TriHealth Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 15, 2017

Study Start

June 14, 2017

Primary Completion

August 5, 2019

Study Completion

August 5, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)