Computerized Cardiotocography Monitoring of Fetuses With pPROM

Study Overview
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Brief Summary
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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
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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.

Official Title
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Computerized Cardiotocography Monitoring in Fetuses With Preterm Premature Rupture of Membranes

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

Intervention / Treatment
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* Diagnostic Test: Computerized cardiotocography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pPROM<br>Singleton pregnancies admitted for pPROM to the Obstetrics ward | Diagnostic Test: Computerized cardiotocography<br>* To compare Dawes and Redman indices as determined by computer analysis of the fetal heart tracing<br>|
| Control group<br>Healthy pregnant women matched for gestational age | Diagnostic Test: Computerized cardiotocography<br>* To compare Dawes and Redman indices as determined by computer analysis of the fetal heart tracing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth rate |  | Less than 37 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at delivery |  | Time of delivery | 
| Preterm birth rates |  | Less than 24, 28, 34 weeks gestation | 
| Birth weight | Weight of the baby at the time of delivery | Time of delivery | 
| Low birth weight rate | Birth weight <2500g | Time of delivery | 
| Neonatal death rate |  | Between birth and 28 days of age | 
| 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 | 
| 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 | 
| Dawes and Redman indices | determined by computer analysis of the fetal heart tracing | between 24 and 34 weeks of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiotocography, Premature Rupture of Membrane, computerized cardiotocography, premature birth