Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight

NCT ID: NCT03187938

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

292 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-14

Study Completion Date

2019-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Birth Weight Infants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Testing of Alkaline Phosphatase Levels

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Testing of Alkaline Phosphatase Levels

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Donna Lambers, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Good Samaritan TriHealth Hospital

Cincinnati, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16-095

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Renin and Prorenin in Pregnancy
NCT00005207 COMPLETED