Early Detection of Chorioamnionitis in Preterm Premature Rupture of Membranes
AiRPM
Fetal Heart Rate Variability Analysis for the Early Detection of Chorioamnionitis During Preterm Premature Rupture of Membranes
1 other identifier
observational
120
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2016
CompletedFirst Posted
Study publicly available on registry
September 15, 2016
CompletedStudy Start
First participant enrolled
November 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2022
CompletedMarch 3, 2022
March 1, 2022
3.2 years
September 5, 2016
March 2, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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
The performance indicator
sensibility, specificity of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.
up to delivery
The performance indicator
positive predictive value of the high variation index for the early diagnosis of histologically proven chorioamnionitis during pPROM.
up to delivery
The performance indicator
negative predictive value of the high variation index for the early diagnosis of
up to delivery
Eligibility Criteria
women with pPROM between 26 to 34 WG clinically proven or confirmed by a positive IGBP-1 protein test in a vaginal sample
You may qualify if:
- pPROM between 26 to 34 WG clinically proven or confirmed by a positive IGBP-1 protein test in a vaginal sample
- years old or older
- singleton pregnancy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU Rennes Hôpital Sud
Rennes, Brittany Region, 35000, France
Service de Gynecologie obstétrique
Angers, 49933, France
Service de gynecologique-obstétrique
Nantes, 44093, France
Service de Gynecologie Obstétrique
Poitiers, 86021, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linda Lassel, MD
CHU Rennes Hopital Sud
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2016
First Posted
September 15, 2016
Study Start
November 2, 2018
Primary Completion
January 1, 2022
Study Completion
February 21, 2022
Last Updated
March 3, 2022
Record last verified: 2022-03