Computerized Cardiotocography Monitoring of Fetuses With pPROM

• Conditions: Cardiotocography; Premature Rupture of Membrane; Rupture of Membranes; Premature; Sepsis; Premature Birth
• Interventions: Diagnostic Test: Computerized cardiotocography

• Registration Number: NCT04632017
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Study Timeline

• Study Start: 2020-06-15
• Status Verified: 2020-11
• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-16
• Last Update Submitted: 2020-11-16
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17
• Primary Completion: 2021-03-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Computerized cardiotocography	Healthy pregnant women matched for gestational age
pPROM	Computerized cardiotocography	Singleton pregnancies admitted for pPROM to the Obstetrics ward

Primary Outcome Measures

Name	Time	Method
Preterm birth rate	Less than 37 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Gestational age at delivery	Time of delivery
Low birth weight rate	Time of delivery	Birth weight \<2500g
Dawes and Redman indices	between 24 and 34 weeks of gestation	determined by computer analysis of the fetal heart tracing
Preterm birth rates	Less than 24, 28, 34 weeks gestation
Neonatal death rate	Between birth and 28 days of age
Birth weight	Time of delivery	Weight of the baby at the time of delivery
Composite adverse neonatal outcomes	Between birth and 28 days of age	Number of neonates who will have at least one of the following: necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH) (grade 3 or higher), respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), retinopathy (ROP), blood-culture proven sepsis and neonatal death
Maternal outcomes	Between birth and 28 days after the birth	Number of mothers who will have at least one of the following: sepsis, histological chorioamnionitis, hysterectomy, intensive care unit admission.

Trial Locations

Locations (1)

University of Campania "Luigi Vanvitelli"; 🇮🇹 Naples, Italy