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

NCT ID: NCT02702297

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-07
• Study Completion Date: 2018-11-10

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single arm

daily multimodal monitoring during pregnancy after PPROM, Analysis of neonatal routine parameters and histologic examination of placenta

single arm

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jena University Hospital

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: collaborator

St. Elisabeth Hospital Halle

UNKNOWN

Sponsor Role: collaborator

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role: lead

Responsible Party

Gregor Seliger

Dr. med.; chief resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregor Seliger, Dr. med

Role: PRINCIPAL_INVESTIGATOR

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

Michael Bergner

Role: PRINCIPAL_INVESTIGATOR

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

Uwe Schneider, Prof.

Role: PRINCIPAL_INVESTIGATOR

Maternity Clinic; Jena University Hospital

Michael Tchirikov, Prof.

Role: STUDY_CHAIR

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

Frank Bernhard Kraus, PD; PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Laboratory Medicine; Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

Roland Haase, PD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics; Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

Holger Stepan, Prof.

Role: PRINCIPAL_INVESTIGATOR

Maternity clinic, University of Leipzig

Locations

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

Countries

Germany

Other Identifiers

MuMFI-PPROM

Identifier Type: -

Identifier Source: org_study_id