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

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.

Conditions

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

Interventions

OTHER

single arm

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 & Collaborators

• Jena University Hospital

  collaborator OTHER

• University of Leipzig

  collaborator OTHER

• St. Elisabeth Hospital Halle

  collaborator UNKNOWN

• Martin-Luther-Universität Halle-Wittenberg

  lead OTHER

Principal Investigators

• Gregor Seliger, Dr. med · Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

• Michael Bergner · Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

• Uwe Schneider, Prof. · Maternity Clinic; Jena University Hospital

• Michael Tchirikov, Prof. · Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

• Frank Bernhard Kraus, PD; PhD · Department of Laboratory Medicine; Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

• Roland Haase, PD · Department of Pediatrics; Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

• Holger Stepan, Prof. · Maternity clinic, University of Leipzig

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-07

Primary Completion

2018-02-28

Completion

2018-11-10

Countries

• Germany

Study Locations