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

Preterm Premature Rupture of Membranes Clinical Trial

— MuMFI-PPROM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702297
• Other study ID #: MuMFI-PPROM
• Status: Completed
• Start date: January 7, 2016
• Est. completion date: November 10, 2018

Study information

• Verified date: November 2018
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 10, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Germany	St. Elisabeth Hospital Halle	Halle	Sachsen-Anhalt
Germany	Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg	Halle (Saale)	Sachsen-Anhalt
Germany	Maternity Clinic, Jena University Hospital	Jena	Thüringen
Germany	Maternity clinic, University of Leipzig	Leipzig	Saxony

Sponsors (4)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	Jena University Hospital, St. Elisabeth Hospital Halle, University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	combined neonatal adverse outcome	rate of severe intraventricular hemorrhage, necrotizing enterocolitis, late onset sepsis, white matter damage within the first 28 days of life	28 days
Secondary	late onset neonatal sepsis	clinical Sepsis after first 72h of life	28 days
Secondary	Severe neonatal cerebral hemorrhage	IVH II+IV°	28 days
Secondary	necrotizing enterocolitis	NEC	28 days
Secondary	umbilical cord blood IL 6 concentration	IL-6-concentration in cord blood sample after delivery or in fetal Serum during first hour of life	first day after delivery
Secondary	neonatal early onset sepsis	clinical Sepsis during first 72h of life	3 days
Secondary	histological funisitis	redline maternal stage >1, fetal stage >0	first day after delivery