Multimodal Monitoring of Fetal Risk of Inflammation in Preterm Premature Rupture of Membranes (MuMFI-PPROM)

Martin-Luther-Universität Halle-Wittenberg

Status: Completed

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

Treatments: Other: single arm

Study type: Observational

Funder types: Other

Identifiers

NCT02702297

MuMFI-PPROM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

57 participants in 1 patient group

Single arm

Description:

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

Treatment:

Other: single arm