Computerized Cardiotocography Monitoring of Fetuses With pPROM (COCA-PROM)

University of Campania "Luigi Vanvitelli"

Status: Unknown

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

Treatments: Diagnostic Test: Computerized cardiotocography

Study type: Observational

Funder types: Other

Identifiers

NCT04632017

8452 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

pPROM

Description:

Singleton pregnancies admitted for pPROM to the Obstetrics ward

Treatment:

Diagnostic Test: Computerized cardiotocography

Control group

Description:

Healthy pregnant women matched for gestational age

Treatment:

Diagnostic Test: Computerized cardiotocography