An observational study in Fetal Membranes, Premature Rupture, sponsored by Rennes University Hospital. Completed at 4 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by Rennes University Hospital · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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 high variation episodes (p\<0,001) decreased significantly in pPROM complicated by histological chorioamnionitis. An index based on the high variations episodes was performed and seems a promising tool for the early detection of chorioamnionitis during pPROM (sensitivity 90%, specificity 84.6%, positive predictive value 71.5%, negative predictive value 95.2%, AUC = 0.88, IC 95% 0.73 to 100).
These data are consistent with those observed in neonatology for the assessment of early-onset sepsis and the underlying pathophysiological mechanisms (decreased fetal heart rate variability and adaptability in response to the placental infection/inflammation). Therefore, fetal heart rate (FHR) characteristics could be a potential way of research still unexploited for the early detection of chorioamnionitis in cases of pPROM.
100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.
This study's enrollment of 120 is close to the median of 122 across 36 observational studies indexed under Fetal Membranes, Premature Rupture.
Browse Fetal Membranes, Premature Rupture studies →Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
women with pPROM between 26 to 34 WG clinically proven or confirmed by a positive IGBP-1 protein test in a vaginal sample
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
maternal pathology :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The performance indicator
area under ROC curve of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.
Time frame: up to delivery
The performance indicator
sensibility, specificity of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.
Time frame: up to delivery
The performance indicator
positive predictive value of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.
Time frame: up to delivery
The performance indicator
negative predictive value of the high variation index for the early diagnosis of
Time frame: up to delivery
Ran from Nov 2018 to primary completion in Jan 2022, 37 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fetal Membranes, Premature Rupture →