Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517290
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Evaluation of the Risk of Infection During Fever in Labor
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Risk of Infection During Fever in Labor
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FEVERY
Brief Summary:
Fever during labor affects more than 8 of parturients It is a heterogeneous entity and can be due to an infectious process a side effect of a drug or to labor itself physiological hyperthermia
It has been the subject of several retrospective studies and a few prospective studies with varying methodologies definitions and inclusion criteria None have proposed a combined obstetric neonatal infectious disease and microbiological analysis
It raises concerns about the possibility of an emerging maternal obstetric or otherwise andor fetal infection
Analysis of the available literature does not clarify the exact frequency of these infections or the predictive factors for their occurrence
It often justifies systemic antibiotic therapy the modalities and benefits of which have never been evaluated
The investigators aim to conduct a prospective multicenter study to analyze fever during labor with a combined obstetric infectious disease pediatric and microbiological perspective
It has been the subject of several retrospective studies and a few prospective studies with varying methodologies definitions and inclusion criteria None have proposed a combined obstetric neonatal infectious disease and microbiological analysis
It raises concerns about the possibility of an emerging maternal obstetric or otherwise andor fetal infection
Analysis of the available literature does not clarify the exact frequency of these infections or the predictive factors for their occurrence
It often justifies systemic antibiotic therapy the modalities and benefits of which have never been evaluated
The investigators aim to conduct a prospective multicenter study to analyze fever during labor with a combined obstetric infectious disease pediatric and microbiological perspective
Detailed Description:
The primary objective of this study is to analyze the causes of fever during labor by categorizing them into 3 etiological categories
1 Fever indicative of maternofetal infection potentially early intrauterine infection leading to proven or probable early-onset neonatal bacterial infection endometritis or maternal sepsis
2 Fever indicative of maternal infectious pathology outside the obstetrical field eg pyelonephritis influenza COVID etc
3 Fever of non-infectious origin
Secondary objectives include
Describing the epidemiology and local ecology of bacterial infections
Identifying predictive factors for each category obstetrical infection non-obstetrical infection and non-infectious fever when fever occurs during labor
Evaluating the maternal and neonatal prognosis of mother-child pairs who do not receive antibiotic treatment according to local protocols eg in cases of fever below a threshold value
Depending on the results and sample size the study will also attempt to evaluate the maternal and neonatal prognosis of mother-child pairs in cases where fever is attributed to maternofetal infectious causes category 1 according to the antibiotic management strategy for fever during labor at each center
1 Fever indicative of maternofetal infection potentially early intrauterine infection leading to proven or probable early-onset neonatal bacterial infection endometritis or maternal sepsis
2 Fever indicative of maternal infectious pathology outside the obstetrical field eg pyelonephritis influenza COVID etc
3 Fever of non-infectious origin
Secondary objectives include
Describing the epidemiology and local ecology of bacterial infections
Identifying predictive factors for each category obstetrical infection non-obstetrical infection and non-infectious fever when fever occurs during labor
Evaluating the maternal and neonatal prognosis of mother-child pairs who do not receive antibiotic treatment according to local protocols eg in cases of fever below a threshold value
Depending on the results and sample size the study will also attempt to evaluate the maternal and neonatal prognosis of mother-child pairs in cases where fever is attributed to maternofetal infectious causes category 1 according to the antibiotic management strategy for fever during labor at each center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None