CardiotocographyCOCA-PROMNCT04632017
Computerized Cardiotocography Monitoring of Fetuses With pPROM
An observational study of Cardiotocography and Premature Rupture of Membrane, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cardiotocography, Premature Rupture of Membrane, Rupture of Membranes; Premature
- What is being tested?
- Computerized cardiotocography
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2020to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: Singleton pregnancies admitted for pPROM to the Obstetrics ward of this Hospital will be recruited after informed consent.
Who may be able to join
- pPROM between 24 and 34 weeks (w)
Who cannot join
- multiple pregnancy, structural fetal anomalies, preexisting or gestational diabetes mellitus and\or hypertension, intrauterine growth restriction.
Trial locations and contacts
1 site in 1 country.
Fabiana Savoia, MD contact
Italy1 site, 1 recruiting
- Recruiting
University of Campania "Luigi Vanvitelli"
Naples, 80138
Maddalena Morlando, MD, +39 333 426 3110, madmorlando@gmail.com
Fabiana Savoia, MD, dott.fabianasavoia@gmail.com
About this study
Official title: Computerized Cardiotocography Monitoring in Fetuses With Preterm Premature Rupture of Membranes
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.
Read the 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.
- Conditions
- Cardiotocography, Premature Rupture of Membrane, Rupture of Membranes; Premature, Sepsis, Premature Birth
- Being tested
- Computerized cardiotocography
- Keywords
- cardiotocography, Premature Rupture of Membrane, computerized cardiotocography, premature birth
- Medical subject headings
- Fetal Membranes, Premature Rupture, Sepsis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cardiotocographyDiagnostic test
To compare Dawes and Redman indices as determined by computer analysis of the fetal heart tracing
| Study group | Role | What they receive |
|---|---|---|
| pPROM | Singleton pregnancies admitted for pPROM to the Obstetrics ward Receives: Diagnostic Test: Computerized cardiotocography | |
| Control group | Healthy pregnant women matched for gestational age Receives: Diagnostic Test: Computerized cardiotocography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm birth rate
Measured: Less than 37 weeks gestation
Secondary outcomes (8)
Gestational age at delivery
Measured: Time of delivery
Preterm birth rates
Measured: Less than 24, 28, 34 weeks gestation
Birth weight
Weight of the baby at the time of delivery
Measured: Time of delivery
Low birth weight rate
Birth weight <2500g
Measured: Time of delivery
Neonatal death rate
Measured: 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
Measured: 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.
Measured: Between birth and 28 days after the birth
Dawes and Redman indices
determined by computer analysis of the fetal heart tracing
Measured: between 24 and 34 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start15 Jun 2020
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotocographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maddalena Morlando, University of Campania Luigi Vanvitelli
- Investigators
- Antonio Schiattarella, MD, Study chair, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632017
- Sponsor's protocol ID
- 8452
- Acronym
- COCA-PROM
- Status last verified
- Nov 2020
- First submitted
- 10 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cardiotocography Monitoring in Fetuses With Preterm Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT04632017
- Acronym / sponsor ID
- COCA-PROM / 8452
- Conditions
- Cardiotocography, Premature Rupture of Membrane, Rupture of Membranes; Premature, Sepsis, Premature Birth
- Keywords
- cardiotocography, Premature Rupture of Membrane, computerized cardiotocography, premature birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pPROM | – | Diagnostic Test: Computerized cardiotocographySingleton pregnancies admitted for pPROM to the Obstetrics ward |
| Control group | – | Diagnostic Test: Computerized cardiotocographyHealthy pregnant women matched for gestational age |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Singleton pregnancies admitted for pPROM to the Obstetrics ward of this Hospital will be recruited after informed consent.
Key inclusion criteria (1 listed)
- pPROM between 24 and 34 weeks (w)
Key exclusion criteria (1 listed)
- multiple pregnancy, structural fetal anomalies, preexisting or gestational diabetes mellitus and\or hypertension, intrauterine growth restriction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized cardiotocographyTo compare Dawes and Redman indices as determined by computer analysis of the fetal heart tracing | Diagnostic test | Control group, pPROM |
Primary outcome
Preterm birth rate
Time frame: Less than 37 weeks gestation
8 secondary outcomes
Gestational age at delivery
Time frame: Time of delivery
Preterm birth rates
Time frame: Less than 24, 28, 34 weeks gestation
Birth weight
Time frame: Time of delivery
Low birth weight rate
Time frame: Time of delivery
Neonatal death rate
Time frame: Between birth and 28 days of age
Composite adverse neonatal outcomes
Time frame: Between birth and 28 days of age
Maternal outcomes
Time frame: Between birth and 28 days after the birth
Dawes and Redman indices
Time frame: between 24 and 34 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabiana Savoia, MD contact
Antonio Schiattarella, MD study chair
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotocography and Premature Rupture of Membrane, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maddalena Morlando, MD (+39 333 426 3110, madmorlando@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm birth rate (time frame: Less than 37 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.