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

NCT03122808 | Completed

• 1 other identifier: REC-2015-009
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Encephalopathy

Keywords

Tachysystole; Excessive Uterine Activity

Outcome Measures

Primary Outcomes (1)

• 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.

  Whole CTG recording from start of labour to delivery

Secondary Outcomes (1)

• Rest interval as a percentage of contraction-rest interval cycle

  Whole CTG recording from start of labour to delivery

Other Outcomes (3)

• Contraction rate

  Whole CTG recording from start of labour to delivery

• Contraction duration

  Whole CTG recording from start of labour to delivery

• Excessive Uterine Activity Score

  Whole CTG recording from start of labour to delivery

Study Arms (2)

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; 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

Diagnostic Test: Uterine Activity Analysis; Diagnostic Test: Partogram Analysis

Interventions

Uterine Activity Analysis DIAGNOSTIC_TEST

Analysis of components of uterine activity; contraction rate, length of contraction, length of relaxation and other values based off these measurements.

Control; Neonatal encephalopathy

Partogram Analysis DIAGNOSTIC_TEST

Analysis of slope of partogram

Control; Neonatal encephalopathy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Moderate or severe neonatal encephalopathy
• Gestational age of 35+0 weeks or greater
• Singleton pregnancy
• Inborn

You may not qualify if:

• Non-hypoxic-ischaemic aetiology or postnatal hypoxic-ischaemia
• Major congenital abnormalities
• Less than 15 minutes of digital CTG recording from labour available Controls
• Gestational age of 35+0 weeks or greater
• Singleton pregnancy
• Inborn
• 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

Sponsors & Collaborators

• The Rotunda Hospital: lead

Study Sites (1)

The Rotunda Hospital

Dublin, Co. Dublin, Ireland

Location

Study Officials

• Breda Hayes, MD

  The Rotunda Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neonatologist

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 21, 2017
• Study Start: September 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: October 18, 2021
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)