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Computerized Cardiotocography Monitoring of Fetuses With pPROM

NCT04632017 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2020-11-17

No results posted yet for this study

Summary

Preterm premature rupture of membranes (PPROM) is associated with neonatal complications leading to a high rate of cerebral palsy, sepsis, and death. Choosing the best time of delivery is crucial to improve fetal outcome. The balance is between a premature delivery exposing the infant to all the risk of prematurity, and keeping the baby in utero, prolonging the exposure to an adverse intrauterine milieu. There are no objective and reproducible tools to help in this decision-making process. Techniques most frequently used for fetal surveillance are biased by high inter- and intra-observer variability. Computerized cardiotocography (cCTG) identifies several objective parameters related to fetal heart rate (FHR) to determine fetal well-being. cCTG has been successfully used in fetuses with intrauterine growth restriction, but it has never been used in prospective studies to assess its role in the management of fetuses with PPROM. The investigators designed a case control study to highlight cCTG differences in PPROM pregnancies versus physiological pregnancies, to establish the effectiveness in predicting adverse outcome, and to develop a score to predict neonatal outcome.

Conditions

  • Cardiotocography
  • Premature Rupture of Membrane
  • Rupture of Membranes; Premature
  • Sepsis
  • Premature Birth

Interventions

DIAGNOSTIC_TEST

Computerized cardiotocography

To compare Dawes and Redman indices as determined by computer analysis of the fetal heart tracing

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Antonio Schiattarella, MD · University of Campania Luigi Vanvitelli

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2021-03-30
Completion
2021-07-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632017 on ClinicalTrials.gov