Combined Systemic Inflammatory Indices and Birth Weight

April 16, 2024 updated by: Marco La Verde, University of Campania "Luigi Vanvitelli"

Combined Systemic Inflammatory Indices and Their Impact on Birth Weight: A Prospective Observational Study.

The study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research was structured as a prospective observational study. It was conducted at a second-level University Hospital over the period from December 2019 to February 2021.

Participants:

Blood samples were collected at hospital admission. These samples were used for a complete blood count, focusing specifically on deriving systemic inflammatory indices.

The primary inflammatory indices studied were Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), and Monocyte-to-Lymphocyte Ratio (MLR).

The birth weight was registered.

Study Type

Observational

Enrollment (Actual)

199

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
    • Italia
      • Napoli, Italia, Italy, 80138
        • Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population comprised full-term pregnant women. These participants were likely to represent a diverse range of ages and backgrounds, typical of a general pregnant population at a second-level University Hospital.

Health Status: The women included were in generally good health, with full-term, uncomplicated pregnancies. This was ensured by the rigorous exclusion of any pregnancies affected by significant health issues such as diabetes, hypertension, and other specified conditions.

Description

Inclusion Criteria:

  • physiological Full-term pregnancies

Exclusion Criteria:

  • gestational diabetes
  • pregestational diabetes
  • Chronic Hypertension
  • Gestational Hypertension
  • Preeclampsia
  • Eclampsia
  • Intrauterine Fetal Growth Restriction
  • Preterm Delivery
  • Multiple Pregnancies
  • Fetal malformations

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
full term pregnancy

Total Participants: The study included full-term pregnant women.

Exclusion Criteria: Participants were carefully selected, excluding those with specific conditions that could confound the study results. These conditions included gestational and pregestational diabetes, chronic hypertension, gestational hypertension, pre-eclampsia/eclampsia, intrauterine fetal growth restriction, preterm delivery, multiple pregnancies, and prenatally detected fetal abnormalities.
Diagnostic test: None intervention
None intervention, observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic inflammatory indices and birth weight
Time Frame: 3 months
investigate the correlation between systemic inflammatory indices and birth weight in full-term pregnancies
3 months

Collaborators and Investigators

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

Sponsor

University of Campania "Luigi Vanvitelli"

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)

December 1, 2019

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98

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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