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

NCT02702297 | Completed

• 1 other identifier: MuMFI-PPROM
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  postpartum one point assessment/ first three days post partum

Secondary Outcomes (7)

• combined neonatal adverse outcome

  28 days

• late onset neonatal sepsis

  28 days

• Severe neonatal cerebral hemorrhage

  28 days

• necrotizing enterocolitis

  28 days

• umbilical cord blood IL 6 concentration

  first day after delivery

Study Arms (1)

Single arm

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

Other: single arm

Interventions

single arm 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.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with PPROM-complicated pregnancies who referre to one of the participating tertiary referreal care centers.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Martin-Luther-Universität Halle-Wittenberg: lead
• Jena University Hospital: collaborator
• University of Leipzig: collaborator
• St. Elisabeth Hospital Halle: collaborator

Study Sites (4)

Maternity clinic, University of Leipzig

Leipzig, Saxony, 04103, Germany

Location

St. Elisabeth Hospital Halle

Halle, Saxony-Anhalt, 06110, Germany

Location

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

Halle, Saxony-Anhalt, 06120, Germany

Location

Maternity Clinic, Jena University Hospital

Jena, Thuringia, 07743, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal Fluid

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes; fetal inflammatory response syndrome; Neonatal Sepsis; Chorioamnionitis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases

Study Officials

• Gregor Seliger, Dr. med

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

  PRINCIPAL INVESTIGATOR

• Michael Bergner

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

  PRINCIPAL INVESTIGATOR

• Uwe Schneider, Prof.

  Maternity Clinic; Jena University Hospital

  PRINCIPAL INVESTIGATOR

• Michael Tchirikov, Prof.

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

  STUDY CHAIR

• Frank Bernhard Kraus, PD; PhD

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

  PRINCIPAL INVESTIGATOR

• Roland Haase, PD

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

  PRINCIPAL INVESTIGATOR

• Holger Stepan, Prof.

  Maternity clinic, University of Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.; chief resident

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 8, 2016
• Study Start: January 7, 2016
• Primary Completion: February 28, 2018
• Study Completion: November 10, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

DE (4)