Neonatal EncephalopathyNCT03122808
Uterine Activity in Moderate-Severe Neonatal Encephalopathy: A Case Control Study
An observational study of Neonatal Encephalopathy, run by The Rotunda Hospital at 1 site in Ireland.
Trial summary
Excessive uterine activity may be one of several aetiological factors that contribute to depressed neurological function in the newborn. During labour, uterine contractions can compress the fetal cranium at pressures high enough to impair cerebral perfusion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatal Encephalopathy
- What is being tested?
- Uterine Activity Analysis and Partogram Analysis
- How many people
- 264 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 2016to 18 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population is babies born in the Rotunda hospital since 2005, when digital archiving of cardiotocographs began. The Rotunda Hospital is a level 3 maternity hospital located in Ireland with approximately 9,000 deliveries per year. The incidence of moderate or severe neonatal encephalopathy in the population is approximately one per 1000 births.
Cases
The inclusion criteria will be:
- Moderate or severe neonatal encephalopathy
- Gestational age of 35+0 weeks or greater
- Singleton pregnancy
- Inborn
The exclusion criteria will be:
- Non-hypoxic-ischaemic aetiology or postnatal hypoxic-ischaemia
- Major congenital abnormalities
- Less than 15 minutes of digital CTG recording from labour available Controls
The inclusion criteria will be:
- Gestational age of 35+0 weeks or greater
- Singleton pregnancy
- Inborn
The exclusion criteria will be:
- APGAR score of less than 5 at 1 minute or less than 7 at 5 or 10 minutes
- Admission to the neonatal unit
- Major congenital abnormalities
- Less than 15 minutes of digital CTG recording from labour available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrapartum Uterine Activity Monitoring and Partogram Characteristics: Can They Help Predict Foetuses With Poor Tolerance of Labour?
Excessive uterine activity may be one of several aetiological factors that contribute to depressed neurological function in the newborn. During labour, uterine contractions can compress the fetal cranium at pressures high enough to impair cerebral perfusion. Contraction rates greater than 7 in 15 minutes are associated with an increased risk of neonatal encephalopathy.
The American Congress of Obstetricians and Gynecologists defines uterine tachysystole as more than 5 contractions in 10 minutes, averaged over a 30-minute window. By this definition, excessive uterine activity is common and, at best, a non-specific predictor of depressed neurological function in the newborn. There is a need for predictors of neonatal encephalopathy that are more specific and clinically applicable.
Read more
Contraction and relaxation duration are two measures that closely reflect the proposed role of excessive uterine activity in the pathogenesis of neonatal encephalopathy. Prolonged contractions with short relaxation periods result in progressive reductions in fetal cerebral oxygenation. Shorter uterine contraction periods are associated with an increased risk of low umbilical cord potential of hydrogen (pH) values.
Our primary aim is to measure parameters of uterine activity, for example relaxation and contraction duration, and determine their relationship with the risk of neonatal encephalopathy. We will also investigate how measures of uterine activity interact with other measures of labour and fetal well-being, including cervical dilation rates and fetal heart rate patterns. In babies with neonatal encephalopathy, we will investigate the relationship of uterine activity with electrophysiological, radiological and developmental outcomes.
We will perform a retrospective case-control study of babies born in the Rotunda hospital from 2005 until the present. The assessor of the Cardiotocograph (CTG) recordings will be blind to the disease status of the infants. For each recording, every uterine contraction and rest interval will be measured. Summary variables created from these measures will be used to compare the case and control groups. The primary variable will be mean rest interval duration.
Read the detailed description
The advent of therapeutic hypothermia has improved outcomes for babies born with hypoxic-ischemic encephalopathy. However, the risk of death, seizures, cerebral palsy or intellectual impairment remains significant, especially among the most severely affected infants. Prevention remains a promising strategy to reduce the incidence of complications arising from hypoxic-ischaemic neonatal encephalopathy.
Excessive uterine activity may be one of several aetiological factors that contribute to depressed neurological function in the newborn. During labour, uterine contractions can compress the fetal cranium at pressures high enough to impair cerebral perfusion. Contraction rates greater than 7 in 15 minutes are associated with an increased risk of neonatal encephalopathy.
The American Congress of Obstetricians and Gynecologists defines uterine tachysystole as more than 5 contractions in 10 minutes, averaged over a 30-minute window. By this definition, excessive uterine activity is common and, at best, a non-specific predictor of depressed neurological function in the newborn. There is a need for predictors of neonatal encephalopathy that are more specific and clinically applicable.
Contraction and relaxation duration are two measures that closely reflect the proposed role of excessive uterine activity in the pathogenesis of neonatal encephalopathy. Prolonged contractions with short relaxation periods result in progressive reductions in fetal cerebral oxygenation. Shorter uterine contraction periods are associated with an increased risk of low umbilical cord pH values.
Our primary aim is to measure parameters of uterine activity, for example relaxation and contraction duration, and determine their relationship with the risk of neonatal encephalopathy. We will also investigate how measures of uterine activity interact with other measures of labour and fetal well-being, including cervical dilation rates and fetal heart rate patterns. In babies with neonatal encephalopathy, we will investigate the relationship of uterine activity with electrophysiological, radiological and developmental outcomes.
We will perform a retrospective case-control study of babies born in the Rotunda hospital from 2005 until the present. Cases and controls must be over 35 weeks gestational age and have at least 15 minutes of Cardiotocograph (CTG) recording from labour available for analysis. Cases will be babies with moderate or severe neonatal encephalopathy of apparent hypoxic-ischemic aetiology. Controls will be the first healthy babies born before and after the cases to satisfy the study criteria. Controls will be matched for parity.
The assessor of the CTG recordings will be blind to the disease status of the infants. For each recording, every uterine contraction and rest interval will be measured. Summary variables created from these measures will be used to compare the case and control groups. The primary variable will be mean rest interval duration.
For further detail please see the study protocol.
- Conditions
- Neonatal Encephalopathy
- Being tested
- Uterine Activity Analysis, Partogram Analysis
- Keywords
- Tachysystole, Excessive Uterine Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine Activity AnalysisDiagnostic test
Analysis of components of uterine activity; contraction rate, length of contraction, length of relaxation and other values based off these measurements.
Partogram AnalysisDiagnostic test
Analysis of slope of partogram
| Study group | Role | What they receive |
|---|---|---|
| Neonatal encephalopathy | The inclusion criteria will be:
* Moderate or severe neonatal encephalopathy
* Gestational age of 35+0 weeks or greater
* Singleton pregnancy
* Inborn
The exclusion criteria will be:
* Non-hypoxic-ischaemic aetiology or postnatal hypoxic-ischaemia
* Major congenital abnormalities
* Less than 15 minutes of digital CTG recording from labour available Receives: Diagnostic Test: Uterine Activity Analysis; Diagnostic Test: Partogram Analysis | |
| Control | The inclusion criteria will be:
* Gestational age of 35+0 weeks or greater
* Singleton pregnancy
* Inborn
The exclusion criteria will be:
* APGAR score of less than 5 at 1 minute or less than 7 at 5 or 10 minutes
* Admission to the neonatal unit
* Major congenital abnormalities
* Less than 15 minutes of digital CTG recording from labour available Receives: Diagnostic Test: Uterine Activity Analysis; Diagnostic Test: Partogram Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rest interval duration
Expressed as mean, maximum, 90th centile. Individual uterine activity measures will be analysed both as continuous and categorised variables and in terms of minutes elapsed above a certain threshold that is to be determined.
Measured: Whole CTG recording from start of labour to delivery
Secondary outcomes (1)
Rest interval as a percentage of contraction-rest interval cycle
Expressed as mean, maximum, 90th centile. Individual uterine activity measures will be analysed both as continuous and categorised variables and in terms of minutes elapsed above a certain threshold that is to be determined.
Measured: Whole CTG recording from start of labour to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Sep 2016
- Primary completion1 Jan 2021
- Study completion18 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal EncephalopathyStudies 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
- Retrospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Rotunda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Breda Hayes, The Rotunda Hospital
- Investigators
- Breda Hayes, MD, Principal investigator, The Rotunda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122808
- Sponsor's protocol ID
- REC-2015-009
- Status last verified
- May 2023
- First submitted
- 18 Apr 2017
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Uterine Activity Monitoring and Partogram Characteristics: Can They Help Predict Foetuses With Poor Tolerance of Labour?
- ClinicalTrials.gov ID
- NCT03122808
- Acronym / sponsor ID
- REC-2015-009
- Conditions
- Neonatal Encephalopathy
- Keywords
- Tachysystole, Excessive Uterine Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- The Rotunda HospitalUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 21 Apr 2017 (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.
Excessive uterine activity may be one of several aetiological factors that contribute to depressed neurological function in the newborn. During labour, uterine contractions can compress the fetal cranium at pressures high enough to impair cerebral perfusion. Contraction rates greater than 7 in 15 minutes are associated with an increased risk of neonatal encephalopathy.
The American Congress of Obstetricians and Gynecologists defines uterine tachysystole as more than 5 contractions in 10 minutes, averaged over a 30-minute window. By this definition, excessive uterine activity is common and, at best, a non-specific predictor of depressed neurological function in the newborn. There is a need for predictors of neonatal encephalopathy that are more specific and clinically applicable.
Contraction and relaxation duration are two measures that closely reflect the proposed role of excessive uterine activity in the pathogenesis of neonatal encephalopathy. Prolonged contractions with short relaxation periods result in progressive reductions in fetal cerebral oxygenation. Shorter uterine contraction periods are associated with an increased risk of low umbilical cord potential of hydrogen (pH) values.
Our primary aim is to measure parameters of uterine activity, for example relaxation and contraction duration, and determine their relationship with the risk of neonatal encephalopathy. We will also investigate how measures of uterine activity interact with other measures of labour and fetal well-being, including cervical dilation rates and fetal heart rate patterns. In babies with neonatal encephalopathy, we will investigate the relationship of uterine activity with electrophysiological, radiological and developmental outcomes.
We will perform a retrospective case-control study of babies born in the Rotunda hospital from 2005 until the present. The assessor of the Cardiotocograph (CTG) recordings will be blind to the disease status of the infants. For each recording, every uterine contraction and rest interval will be measured. Summary variables created from these measures will be used to compare the case and control groups. The primary variable will be mean rest interval duration.
Detailed description
The advent of therapeutic hypothermia has improved outcomes for babies born with hypoxic-ischemic encephalopathy. However, the risk of death, seizures, cerebral palsy or intellectual impairment remains significant, especially among the most severely affected infants. Prevention remains a promising strategy to reduce the incidence of complications arising from hypoxic-ischaemic neonatal encephalopathy.
Excessive uterine activity may be one of several aetiological factors that contribute to depressed neurological function in the newborn. During labour, uterine contractions can compress the fetal cranium at pressures high enough to impair cerebral perfusion. Contraction rates greater than 7 in 15 minutes are associated with an increased risk of neonatal encephalopathy.
The American Congress of Obstetricians and Gynecologists defines uterine tachysystole as more than 5 contractions in 10 minutes, averaged over a 30-minute window. By this definition, excessive uterine activity is common and, at best, a non-specific predictor of depressed neurological function in the newborn. There is a need for predictors of neonatal encephalopathy that are more specific and clinically applicable.
Contraction and relaxation duration are two measures that closely reflect the proposed role of excessive uterine activity in the pathogenesis of neonatal encephalopathy. Prolonged contractions with short relaxation periods result in progressive reductions in fetal cerebral oxygenation. Shorter uterine contraction periods are associated with an increased risk of low umbilical cord pH values.
Our primary aim is to measure parameters of uterine activity, for example relaxation and contraction duration, and determine their relationship with the risk of neonatal encephalopathy. We will also investigate how measures of uterine activity interact with other measures of labour and fetal well-being, including cervical dilation rates and fetal heart rate patterns. In babies with neonatal encephalopathy, we will investigate the relationship of uterine activity with electrophysiological, radiological and developmental outcomes.
We will perform a retrospective case-control study of babies born in the Rotunda hospital from 2005 until the present. Cases and controls must be over 35 weeks gestational age and have at least 15 minutes of Cardiotocograph (CTG) recording from labour available for analysis. Cases will be babies with moderate or severe neonatal encephalopathy of apparent hypoxic-ischemic aetiology. Controls will be the first healthy babies born before and after the cases to satisfy the study criteria. Controls will be matched for parity.
The assessor of the CTG recordings will be blind to the disease status of the infants. For each recording, every uterine contraction and rest interval will be measured. Summary variables created from these measures will be used to compare the case and control groups. The primary variable will be mean rest interval duration.
For further detail please see the study protocol.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonatal encephalopathy | – | Diagnostic Test: Uterine Activity Analysis, Diagnostic Test: Partogram AnalysisThe inclusion criteria will be: * Moderate or severe neonatal encephalopathy * Gestational age of 35+0 weeks or greater * Singleton pregnancy * Inborn The exclusion criteria will be: * Non-hypoxic-ischaemic aetiology or postnatal hypoxic-ischaemia * Major congenital abnormalities * Less than 15 minutes of digital CTG recording from labour available |
| Control | – | Diagnostic Test: Uterine Activity Analysis, Diagnostic Test: Partogram AnalysisThe inclusion criteria will be: * Gestational age of 35+0 weeks or greater * Singleton pregnancy * Inborn The exclusion criteria will be: * APGAR score of less than 5 at 1 minute or less than 7 at 5 or 10 minutes * Admission to the neonatal unit * Major congenital abnormalities * Less than 15 minutes of digital CTG recording from labour available |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is babies born in the Rotunda hospital since 2005, when digital archiving of cardiotocographs began. The Rotunda Hospital is a level 3 maternity hospital located in Ireland with approximately 9,000 deliveries per year. The incidence of moderate or severe neonatal encephalopathy in the population is approximately one per 1000 births.
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 |
|---|---|---|
| Uterine Activity AnalysisAnalysis of components of uterine activity; contraction rate, length of contraction, length of relaxation and other values based off these measurements. | Diagnostic test | Control, Neonatal encephalopathy |
| Partogram AnalysisAnalysis of slope of partogram | Diagnostic test | Control, Neonatal encephalopathy |
Primary outcome
Rest interval duration
Time frame: Whole CTG recording from start of labour to delivery
Expressed as mean, maximum, 90th centile. Individual uterine activity measures will be analysed both as continuous and categorised variables and in terms of minutes elapsed above a certain threshold that is to be determined.
1 secondary outcome
Rest interval as a percentage of contraction-rest interval cycle
Time frame: Whole CTG recording from start of labour to delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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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.
Breda Hayes, MD principal investigator
The Rotunda Hospital
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 Neonatal Encephalopathy, run by The Rotunda Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. 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 Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rest interval duration (time frame: Whole CTG recording from start of labour to delivery). 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 22 May 2023.