Computerized Cardiotocography Monitoring of Fetuses With pPROM

Sepsis Clinical Trial

— COCA-PROM  

Official title:

Computerized Cardiotocography Monitoring in Fetuses With Preterm Premature Rupture of Membranes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04632017
• Other study ID #: 8452
• Status: Recruiting
• Start date: June 15, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: November 2020
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Maddalena Morlando, MD
• Phone: +39 333 426 3110
• Email: madmorlando[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 30, 2021
• Est. primary completion date: March 30, 2021
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Computerized cardiotocography
To compare Dawes and Redman indices as determined by computer analysis of the fetal heart tracing

Locations

Country	Name	City	State
Italy	University of Campania "Luigi Vanvitelli"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm birth rate		Less than 37 weeks gestation
Secondary	Gestational age at delivery		Time of delivery
Secondary	Preterm birth rates		Less than 24, 28, 34 weeks gestation
Secondary	Birth weight	Weight of the baby at the time of delivery	Time of delivery
Secondary	Low birth weight rate	Birth weight <2500g	Time of delivery
Secondary	Neonatal death rate		Between birth and 28 days of age
Secondary	Composite adverse neonatal outcomes	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	Between birth and 28 days of age
Secondary	Maternal outcomes	Number of mothers who will have at least one of the following: sepsis, histological chorioamnionitis, hysterectomy, intensive care unit admission.	Between birth and 28 days after the birth
Secondary	Dawes and Redman indices	determined by computer analysis of the fetal heart tracing	between 24 and 34 weeks of gestation