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Completed

NCT Number: NCT02702297

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

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.

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Key information

Conditions

Preterm Premature Rupture of Membranes Chorioamnionitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Early Onset Neonatal Sepsis Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Inflammatory Response Syndrome Fetal Membranes, Premature Rupture Infant, Newborn, Diseases Infection of Amniotic Cavity Infections Inflammation Neonatal Sepsis Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Placenta Diseases Pregnancy Complications Preterm Premature Rupture of the Membranes Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Maternity clinic, University of Leipzig, Leipzig, Saxony, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Odds ratio for severe fetal/early onset neonatal Infection

    Time frame: postpartum one point assessment/ first three days post partum

    combined outcome - rate of: early onset neonatal sepsis, elevated IL6 concentration in cord blood sample, histological signs of funisitis

Secondary outcomes

  1. combined neonatal adverse outcome

    Time frame: 28 days

    rate of severe intraventricular hemorrhage, necrotizing enterocolitis, late onset sepsis, white matter damage within the first 28 days of life

  2. late onset neonatal sepsis

    Time frame: 28 days

    clinical Sepsis after first 72h of life

  3. Severe neonatal cerebral hemorrhage

    Time frame: 28 days

    IVH II+IV°

  4. necrotizing enterocolitis

    Time frame: 28 days

    NEC

  5. umbilical cord blood IL 6 concentration

    Time frame: first day after delivery

    IL-6-concentration in cord blood sample after delivery or in fetal Serum during first hour of life

  6. neonatal early onset sepsis

    Time frame: 3 days

    clinical Sepsis during first 72h of life

  7. histological funisitis

    Time frame: first day after delivery

    redline maternal stage >1, fetal stage >0

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Collaborators

  • Jena University Hospital
  • St. Elisabeth Hospital Halle
  • University of Leipzig

Registry information

Official study title

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

Acronym: MuMFI-PPROM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2016
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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