Computerized Cardiotocography Monitoring in Fetuses With Preterm Premature Rupture of Membranes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiotocography
- Sponsor
- University of Campania "Luigi Vanvitelli"
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Preterm birth rate
- Last Updated
- 5 years ago
Overview
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.
Investigators
Maddalena Morlando
Assistant Professor
University of Campania "Luigi Vanvitelli"
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.
Outcomes
Primary Outcomes
Preterm birth rate
Time Frame: Less than 37 weeks gestation
Secondary Outcomes
- Gestational age at delivery(Time of delivery)
- Low birth weight rate(Time of delivery)
- Dawes and Redman indices(between 24 and 34 weeks of gestation)
- 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)
- Composite adverse neonatal outcomes(Between birth and 28 days of age)
- Maternal outcomes(Between birth and 28 days after the birth)