Early Detection of Chorioamnionitis in Preterm Premature Rupture of Membranes

Fetal Membranes, Premature Rupture Clinical Trial

— AiRPM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901795
• Other study ID #: 35RC14_9772
• Status: Completed
• Start date: November 2, 2018
• Est. completion date: February 21, 2022

Study information

• Verified date: March 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 21, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pPROM between 26 to 34 WG clinically proven or confirmed by a positive IGBP-1 protein test in a vaginal sample

• 18 years old or older

• singleton pregnancy

Exclusion Criteria:

• multiple pregnancy

• intra-uterine growth restriction defined by a fetal weight under the 10th percentile (AUDIPOG)

• active smoking

• gestational diabetes or pre-existing diabetes mellitus

• maternal pathology :

• congenital or acquired heart defect

• pulmonary embolism in progress or under treatment

• pulmonary hypertension

• renal insufficiency

• Chronic obstructive pulmonary disease

• systemic lupus erythematosus, multiple sclerosis, Sjögren's syndrome

• heart, neurological or genetic fetal proven malformations

Related Conditions & MeSH terms

• Chorioamnionitis
• Fetal Membranes, Premature Rupture
• Premature Birth
• Rupture

Locations

Country	Name	City	State
France	Service de Gynecologie obstétrique	Angers
France	Service de gynecologique-obstétrique	Nantes
France	Service de Gynecologie Obstétrique	Poitiers
France	CHU Rennes Hôpital Sud	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The performance indicator	area under ROC curve of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.	up to delivery
Primary	The performance indicator	sensibility, specificity of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.	up to delivery
Primary	The performance indicator	positive predictive value of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.	up to delivery
Primary	The performance indicator	negative predictive value of the high variation index for the early diagnosis of	up to delivery