NCT06325735

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 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

Study Start

First participant enrolled

December 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

March 10, 2024

Last Update Submit

April 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Systemic inflammatory indices and birth weight

    investigate the correlation between systemic inflammatory indices and birth weight in full-term pregnancies

    3 months

Study Arms (1)

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

Interventions

None interventionDIAGNOSTIC_TEST

None intervention, observational study

full term pregnancy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • physiological Full-term pregnancies

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -

Napoli, Italia, 80138, Italy

Location

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 22, 2024

Study Start

December 1, 2019

Primary Completion

February 1, 2021

Study Completion

April 1, 2024

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations