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Computerized Cardiotocography Monitoring of Fetuses With pPROM

NCT ID: NCT04632017

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-07-30

Brief Summary

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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.

Detailed Description

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Preterm premature rupture of membranes (PPROM) occurs in 2 to 3% of pregnancies and is associated with higher maternal and neonatal morbidity and mortality. Neonatal complications are primarily due to prematurity and to ascending infection of the amniotic cavity (chorioamnionitis), leading to a high rate of cerebral palsy, intracranial hemorrhage, sepsis, pneumonia, and death. Every physician is confronted with an extremely difficult and at the same time of paramount importance decision, when it comes to establish the timing of the delivery of a premature fetus with PPROM. The balance is between delivering a premature infant exposed to all the risk of prematurity, and keeping the baby in utero, prolonging the exposure to an adverse intrauterine milieu. At present, there are no objective and reproducible tools to help in this decision-making process. The technique most frequently used for fetal surveillance is cardiotocography (CTG). Assessment of the fetal heart rate is classified subjectively as 'reassuring' or 'not reassuring'. Dawes and Redman have suggested computerized CTG (cCTG), which eliminates inter- and intra-observer variability, identifying several objective parameters to determine fetal well-being. After the multicentre TRUFFLE-Study, cCTG became the best tool to manage fetuses with intrauterine growth restriction (IUGR). However, the use of cCTG has never been investigated in prospective studies to assess its role in the management of fetuses with PPROM. Of note, amniotic fluid concentration of glucose, lactate, interleukin-6 (IL-6), and matrix metalloproteinase-8 (MMP-8) have been associated with neonatal septicemia, chorioamnionitis, preterm birth, and/or fetal inflammatory response syndrome in women with pPROM.

Conditions

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

Keywords

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cardiotocography Premature Rupture of Membrane computerized cardiotocography premature birth

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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pPROM

Singleton pregnancies admitted for pPROM to the Obstetrics ward

Computerized cardiotocography

Intervention Type DIAGNOSTIC_TEST

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

Control group

Healthy pregnant women matched for gestational age

Computerized cardiotocography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Computerized cardiotocography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* pPROM between 24 and 34 weeks (w)

Exclusion Criteria

* multiple pregnancy, structural fetal anomalies, preexisting or gestational diabetes mellitus and\\or hypertension, intrauterine growth restriction.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Maddalena Morlando

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Schiattarella, MD

Role: STUDY_CHAIR

University of Campania Luigi Vanvitelli

Locations

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University of Campania "Luigi Vanvitelli"

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Maddalena Morlando, MD

Role: CONTACT

Phone: +39 333 426 3110

Email: [email protected]

Fabiana Savoia, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Maddalena Morlando, MD

Role: primary

Fabiana Savoia, MD

Role: backup

Other Identifiers

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8452

Identifier Type: -

Identifier Source: org_study_id