Clinical Trial: Early Detection of Chorioamnionitis in Preterm Premature Rupture of Membranes

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Fetal Heart Rate Variability Analysis for the Early Detection of Chorioamnionitis During Preterm Premature Rupture of Membranes

Brief Summary: All included patients will have their fetal heart rate recording performed with an EDAN F3 fetal monitor that allowed the back up recording of the fetal heart rate beat to beat detection. Fetal heart rate variability analysis will be performed using Matalb® software.

Detailed Summary:

Preterm Premature Rupture Of Membranes (pPROM) complicates 2-3% of all pregnancies and is responsible for one-third of preterm birth. Since the membranes generally form a barrier to ascending infection, the second major complication (10-36%) of pPROM is the development of intrauterine infection, called chorioamnionitis. It involves infection/inflammation of the fetus and increases neonatal morbidity and mortality. Indeed, histological chorioamnionitis (microscopic evidence of polynuclear neutrophils on examination of the placenta), regardless the prematurity, creates an inflammatory fetal syndrome which is responsible for an increase rate of cerebral palsy, intracranial hemorrhage, sepsis, pneumonia, respiratory distress syndrome and necrotizing enterocolitis at birth.

During hospitalization, management of women who develop pPROM requires an individual assessment of the benefits and risks of continuing pregnancy versus immediate delivery to avoid chorioamnionitis. Numerous studies in recent years have failed to identify a satisfactory prenatal marker of infection to predict chorioamnionitis. It is now clearly recognized that new markers are needed to improve prediction of infection in cases of pPROM.

A retrospective study (under submission) based on 23 pregnant women with pPROM was performed in the University Hospital of Rennes between 2007 and 2012. For all the patients included, a computerized analysis of the fetal heart rate (Sonicaïd FetalCare Oxford 8002®) has been performed daily during the last six days before delivery and the last recording was made less than 24 hours before the delivery. This study found significant differences of fetal heart rate patterns from pPROM complicated by histological chorioamnionitis compared with pPROM without histological chorioamnionitis. Short term variation (p=0,003) and
Sponsor: Rennes University Hospital

Current Primary Outcome:

• The performance indicator [ Time Frame: up to delivery ]
  area under ROC curve of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.
• The performance indicator [ Time Frame: up to delivery ]
  sensibility, specificity of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.
• The performance indicator [ Time Frame: up to delivery ]
  positive predictive value of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.
• The performance indicator [ Time Frame: up to delivery ]
  negative predictive value of the high variation index for the early diagnosis of

Original Primary Outcome:

• The performance indicator [ Time Frame: up to delivery ]
  area under ROC curve of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.
• The performance indicator [ Time Frame: up to delivery ]
  sensibility, specificity of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.
• The performance indicator [ Time Frame: up to delivery ]
  positive predictive value of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.
• The performance indicator [ Time Frame: up to delivery ]
  nagative predictive value of the high variation index for the early diagnosis of

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Rennes University Hospital

Dates:
Date Received: September 5, 2016
Date Started: December 2014
Date Completion: June 2017
Last Updated: October 3, 2016
Last Verified: August 2016