Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Detection of Chorioamnionitis in Preterm Premature Rupture of Membranes (AiRPM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02901795
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease
Fetal Membranes, Premature Rupture

Detailed 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Fetal Heart Rate Variability Analysis for the Early Detection of Chorioamnionitis During Preterm Premature Rupture of Membranes
Study Start Date : December 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. The performance indicator [ Time Frame: up to delivery ]
    negative predictive value of the high variation index for the early diagnosis of



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women with pPROM between 26 to 34 WG clinically proven or confirmed by a positive IGBP-1 protein test in a vaginal sample
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901795


Contacts
Layout table for location contacts
Contact: Agnes Gazzola agnes.gazzola@chu-rennes.fr

Locations
Layout table for location information
France
CHU Rennes Hôpital Sud Recruiting
Rennes, Bretagne, France, 35000
Contact: Linda Lassel, MD       linda.lassel@chu-rennes.fr   
Service de Gynecologie obstétrique Not yet recruiting
Angers, France, 49933
Contact: Pierre-Emmanuel BOUET, MD         
Service de gynecologique-obstétrique Not yet recruiting
Nantes, France, 44093
Contact: Vincent DOCHEZ, MD         
Service de Gynecologie Obstétrique Not yet recruiting
Poitiers, France, 86021
Contact: Fabrice PIERRE, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Laurent Vandenbroucke, MD CHU Rennes Hopital Sud

Layout table for additonal information
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02901795     History of Changes
Other Study ID Numbers: 35RC14_9772
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Fetal Membranes, Premature Rupture
Chorioamnionitis
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Fetal Diseases
Placenta Diseases