NCT02702297View on ClinicalTrials.gov

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

CompletedOBSERVATIONAL
Enrollment

57

Participants

Timeline

Start Date

January 7, 2016

Primary Completion Date

February 28, 2018

Study Completion Date

November 10, 2018

Conditions
Preterm Premature Rupture of MembranesFetal Inflammatory Response SyndromeEarly Onset Neonatal SepsisInfection 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.

Trial Locations (4)

04103

Maternity clinic, University of Leipzig, Leipzig

06110

St. Elisabeth Hospital Halle, Halle

06120

Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg, Halle

07743

Maternity Clinic, Jena University Hospital, Jena

All Listed Sponsors
collaborator

Jena University Hospital

OTHER

collaborator

University of Leipzig

OTHER

collaborator

St. Elisabeth Hospital Halle

UNKNOWN

lead

Martin-Luther-Universität Halle-Wittenberg

OTHER

NCT02702297 - Multimodal Monitoring of Fetal Risk of Inflammation in Preterm Premature Rupture of Membranes | Biotech Hunter | Biotech Hunter