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Trial record 20 of 4201 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Diseases"

Uterine Activity in Moderate-Severe Neonatal Encephalopathy: A Case Control Study

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ClinicalTrials.gov Identifier: NCT03122808
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Breda Hayes, The Rotunda Hospital

Brief 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. 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.


Condition or disease Intervention/treatment
Neonatal Encephalopathy Diagnostic Test: Uterine Activity Analysis Diagnostic Test: Partogram Analysis

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 Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Intrapartum Uterine Activity Monitoring and Partogram Characteristics: Can They Help Predict Foetuses With Poor Tolerance of Labour?
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : July 2018

Group/Cohort Intervention/treatment
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
Diagnostic Test: Uterine Activity Analysis
Analysis of components of uterine activity; contraction rate, length of contraction, length of relaxation and other values based off these measurements.

Diagnostic Test: Partogram Analysis
Analysis of slope of partogram

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
Diagnostic Test: Uterine Activity Analysis
Analysis of components of uterine activity; contraction rate, length of contraction, length of relaxation and other values based off these measurements.

Diagnostic Test: Partogram Analysis
Analysis of slope of partogram




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rest interval as a percentage of contraction-rest interval cycle [ 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.


Other Outcome Measures:
  1. Contraction rate [ 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.

  2. Contraction 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.

  3. Excessive Uterine Activity Score [ Time Frame: Whole CTG recording from start of labour to delivery ]
    Composite score based on combined assessment of contraction rate, contraction duration and relaxation time.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122808


Contacts
Contact: Adam J Reynolds, MB BCh BAO 00353862201075 areynol@tcd.ie

Locations
Ireland
The Rotunda Hospital Recruiting
Dublin, Co. Dublin, Ireland
Contact: Adam J Reynolds, MB BCh BAO    00353862201075    areynol@tcd.ie   
Principal Investigator: Breda Hayes, MD         
Sponsors and Collaborators
The Rotunda Hospital
Investigators
Principal Investigator: Breda Hayes, MD The Rotunda Hospital

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Responsible Party: Breda Hayes, Consultant Neonatologist, The Rotunda Hospital
ClinicalTrials.gov Identifier: NCT03122808     History of Changes
Other Study ID Numbers: REC-2015-009
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Breda Hayes, The Rotunda Hospital:
Tachysystole
Excessive Uterine Activity

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases