The purpose of this study is to examine whether the value of vaginal fluid cytokine levels as well as computerized fetal ECG analysis are suitable clinical parameters to detect an imminent intra-amniotic inflammation with a high risk of fetal inflammatory response syndrome (FIRS) or a neonatal early onset sepsis (EOS) and whether these parameters can be determined on a daily basis in the clinical monitoring of pregnancies complicated by PPROM.
Preterm premature rupture of membranes (PPROM) is one of the leading causes for preterm birth and adverse neonatal outcome. Between 24 0/7 and 34 0/7 weeks of gestation the prolongation of pregnancy is the recommended course of action to reduce the risks of prematurity in most countries. An intra-amniotic infection resulting in fetal inflammatory response syndrome (FIRS) or early onset neonatal sepsis (EOS) is often associated with high morbidity and mortality. Standard monitoring includes the maternal response to inflammation (i.e. maternal serum parameters) as well as fetal signs of acute FIRS (i.e. fetal tachycardia, high cytokine level in amniotic fluid obtained by amniocentesis). Changes of fetal ECG-parameters are also a sign of an acute FIRS. Currently, there is no adequate parameter for the surveillance of a possible ongoing intra-amniotic infection. Other studies have reported a correlation between vaginal fluid interleukine 6 (IL6) collected noninvasively and the risk of FIRS and EOS. Information obtained by computerized fetal ECG analysis might be suitable to detect early signs of fetal infection before the manifestation of FIRS. With the implementation of a vaginal fluid collector it is possible to detect the vaginal fluid cytokine in clinical everyday routine. With the improvement of fetal ECG monitoring it is possible to record the fetal ECG daily. This study examines the correlation between these new parameters and the onset of fetal infection before the manifestation of a severe systemic fetal inflammation.
Study Type
OBSERVATIONAL
Enrollment
57
Daily monitoring of vaginal fluid IL6 and fetal ECG. Daily maternal monitoring and delivery according to standard operating procedure. Post partum diagnosis of FIRS or EOS by analysing of fetal cord blood IL6 and clinical signs of sepsis. Diagnosis of histologic amniotic infection by histological analysis.
Maternity clinic, University of Leipzig
Leipzig, Saxony, Germany
St. Elisabeth Hospital Halle
Halle, Saxony-Anhalt, Germany
Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, Germany
Maternity Clinic, Jena University Hospital
Jena, Thuringia, Germany
Odds ratio for severe fetal/early onset neonatal Infection
combined outcome - rate of: early onset neonatal sepsis, elevated IL6 concentration in cord blood sample, histological signs of funisitis
Time frame: postpartum one point assessment/ first three days post partum
combined neonatal adverse outcome
rate of severe intraventricular hemorrhage, necrotizing enterocolitis, late onset sepsis, white matter damage within the first 28 days of life
Time frame: 28 days
late onset neonatal sepsis
clinical Sepsis after first 72h of life
Time frame: 28 days
Severe neonatal cerebral hemorrhage
IVH II+IV°
Time frame: 28 days
necrotizing enterocolitis
NEC
Time frame: 28 days
umbilical cord blood IL 6 concentration
IL-6-concentration in cord blood sample after delivery or in fetal Serum during first hour of life
Time frame: first day after delivery
neonatal early onset sepsis
clinical Sepsis during first 72h of life
Time frame: 3 days
histological funisitis
redline maternal stage \>1, fetal stage \>0
Time frame: first day after delivery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.