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Multimodal Monitoring of Fetal Risk of Inflammation in Preterm Premature Rupture of Membranes

Multimodales Monitoring Des Fetalen Inflammationsrisikos Bei frühem Vorzeitigen Blasensprung (PPROM)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02702297
Acronym
MuMFI-PPROM
Enrollment
57
Registered
2016-03-08
Start date
2016-01-07
Completion date
2018-11-10
Last updated
2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Premature Rupture of Membranes, Fetal Inflammatory Response Syndrome, Early Onset Neonatal Sepsis, Infection of Amniotic Cavity

Keywords

Preterm premature rupture of the membranes, PPROM, PROM, fetal membranes, premature rupture, neonatal early onset sepsis, amniotic fluid, amniotic infection, fetal inflammatory response syndrome, adverse neonatal outcome, FIRS

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Jena University Hospital
CollaboratorOTHER
University of Leipzig
CollaboratorOTHER
St. Elisabeth Hospital Halle
CollaboratorUNKNOWN
Martin-Luther-Universität Halle-Wittenberg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of preterm rupture of the fetal membranes * Pregnancy between 24 0/7 and 34 0/7 weeks of gestation * Ability to give informed consent in german or english

Exclusion criteria

* Sign of acute amniotic infection syndrome * independent indication for urgent delivery * Active labor * Missing informed consent

Design outcomes

Primary

MeasureTime frameDescription
Odds ratio for severe fetal/early onset neonatal Infectionpostpartum one point assessment/ first three days post partumcombined outcome - rate of: early onset neonatal sepsis, elevated IL6 concentration in cord blood sample, histological signs of funisitis

Secondary

MeasureTime frameDescription
late onset neonatal sepsis28 daysclinical Sepsis after first 72h of life
Severe neonatal cerebral hemorrhage28 daysIVH II+IV°
necrotizing enterocolitis28 daysNEC
combined neonatal adverse outcome28 daysrate of severe intraventricular hemorrhage, necrotizing enterocolitis, late onset sepsis, white matter damage within the first 28 days of life
neonatal early onset sepsis3 daysclinical Sepsis during first 72h of life
histological funisitisfirst day after deliveryredline maternal stage \>1, fetal stage \>0
umbilical cord blood IL 6 concentrationfirst day after deliveryIL-6-concentration in cord blood sample after delivery or in fetal Serum during first hour of life

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026