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CompletedNCT02901795AiRPMUpdated Mar 3, 2022

Early Detection of Chorioamnionitis in Preterm Premature Rupture of Membranes

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

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Fetal Membranes, Premature Rupture
03

In context

Fetal Membranes, Premature Rupture

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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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

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
    • systemic lupus erythematosus, multiple sclerosis, Sjögren's syndrome
  • heart, neurological or genetic fetal proven malformations
Terms in these criteria, in plain language(1)

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. The performance indicator

    negative predictive value of the high variation index for the early diagnosis of

    Time frame: up to delivery

07

Study locations

4 sites
  • CHU Rennes Hôpital Sud
    Rennes, Bretagne 35000, France
  • Service de Gynecologie obstétrique
    Angers, 49933, France
  • Service de gynecologique-obstétrique
    Nantes, 44093, France
  • Service de Gynecologie Obstétrique
    Poitiers, 86021, France
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

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.

Registered
Sep 5, 2016
First posted
Sep 15, 2016
StartActual
Nov 2, 2018
Primary completionActual
Jan 1, 2022
CompletionActual
Feb 21, 2022
Last update
Mar 3, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02901795
Responsible party
Sponsor
First posted
Sep 15, 2016
Start date
Nov 2, 2018
Primary completion
Jan 1, 2022
Completion
Feb 21, 2022
Last update
Mar 3, 2022

Study contacts

Linda Lassel, MD
principal investigator · CHU Rennes Hopital Sud

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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