Clinical trial NCT04632017: Computerized Cardiotocography Monitoring of Fetuses With pPROM
Official title: Computerized Cardiotocography Monitoring in Fetuses With Preterm Premature Rupture of Membranes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiotocography
Premature Rupture of Membrane
Rupture of Membranes; Premature
Sepsis
Premature Birth
Keywords: cardiotocography
Premature Rupture of Membrane
computerized cardiotocography
premature birth
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Singleton pregnancies admitted for pPROM to the Obstetrics ward of this Hospital will be recruited after informed consent.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Preterm birth rate
timeFrame: Less than 37 weeks gestation
Secondary outcomes:
measure: Gestational age at delivery
timeFrame: Time of delivery
measure: Preterm birth rates
timeFrame: Less than 24, 28, 34 weeks gestation
measure: Birth weight
timeFrame: Time of delivery
measure: Low birth weight rate
timeFrame: Time of delivery
measure: Neonatal death rate
timeFrame: Between birth and 28 days of age
measure: Composite adverse neonatal outcomes
timeFrame: Between birth and 28 days of age
measure: Maternal outcomes
timeFrame: Between birth and 28 days after the birth
measure: Dawes and Redman indices
timeFrame: between 24 and 34 weeks of gestation
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Campania "Luigi Vanvitelli"
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Antonio Schiattarella, MD
role: STUDY_CHAIR
References: