Systemic Inflammation MarkersNCT06325735
Combined Systemic Inflammatory Indices and Birth Weight
An observational study of Systemic Inflammation Markers and Birth Weight, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
The study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Inflammation Markers, Birth Weight, Combined Systemic Inflammatory Indices
- What is being tested?
- None intervention
- How many people
- 199 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2019to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- physiological Full-term pregnancies
Who cannot join
- gestational diabetes
- pregestational diabetes
- Chronic Hypertension
- Gestational Hypertension
- Preeclampsia
- Eclampsia
Show all 10Show fewer
- Intrauterine Fetal Growth Restriction
- Preterm Delivery
- Multiple Pregnancies
- Fetal malformations
Trial locations and contacts
1 site in 1 country.
Italy1 site
Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -
Naples, Italia, 80138
About this study
Official title: 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
Read the 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.
- Being tested
- None intervention
- Medical subject headings
- Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None interventionDiagnostic test
None intervention, observational study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: None intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic inflammatory indices and birth weight
investigate the correlation between systemic inflammatory indices and birth weight in full-term pregnancies
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Dec 2019
- Primary completion1 Feb 2021
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammation MarkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco La Verde, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325735
- Sponsor's protocol ID
- 98
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Systemic Inflammatory Indices and Their Impact on Birth Weight: A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06325735
- Acronym / sponsor ID
- 98
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| full term pregnancy | – | Diagnostic Test: None interventionTotal 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- physiological Full-term pregnancies
Key exclusion criteria (10 listed)
- gestational diabetes
- pregestational diabetes
- Chronic Hypertension
- Gestational Hypertension
- Preeclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None interventionNone intervention, observational study | Diagnostic test | full term pregnancy |
Primary outcome
Systemic inflammatory indices and birth weight
Time frame: 3 months
investigate the correlation between systemic inflammatory indices and birth weight in full-term pregnancies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Systemic Inflammation Markers
RecruitingObservational study
Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery
Diabetic Foot Ulcer, Wound Healing
RecruitingObservational study
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
Blood Stream Infection, Blood Stream Infections
RecruitingPhase 2
The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD
Systemic Lupus Erythematosus, Cardiovascular Disease
Not yet recruitingObservational study
CBC-Derived Inflammatory Indices in Acute Pancreatitis
Acute Pancreatitis, Pancreatitis
Not yet recruiting
Personalized Nutritional Formula for ICU Patients: A Study on Prognosis and Multidimensional Health Markers
Sepsis, Nutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Inflammation Markers and Birth Weight, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic inflammatory indices and birth weight (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.