Contact information
Type
Scientific
Primary contact
Mr Declan Devane
ORCID ID
Contact details
School of Nursing & Midwifery
National University of Ireland
Galway
-
Ireland
-
Declan.Devane@nuig.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RP/2006/55
Study information
Scientific title
Foetal cardiotocography versus intermittent auscultation during labour ward admission: a randomised controlled trial and qualitative follow-up
Acronym
ADCAR
Study hypothesis
The admission cardiotocograph (ACTG), was introduced as a screening test to try and identify foetuses at greater risk of intrapartum asphyxia that might benefit from continuous electronic foetal monitoring (EFM) during labour. Contrary to recommendations that it should not be used for low-risk women (Royal College of Obstetricians and Gynaecologists [RCOG] 2001), an Irish survey found that routine ACTGs were done in 96% of all maternity units in the Republic of Ireland (Devane, Lalor & Bonner 2007). There have been repeated calls for a thorough evaluation of the ACTG through adequately powered randomised trials. The ADCAR trial is designed to provide this evaluation.
Null Hypothesis:
There is no significant difference between admission cardiotocography (ACTG) and intermittent auscultation (IA) of the foetal heart, in low risk women on admission to the labour ward or labour assessment room in:
1. Caesarean section
2. Obstetric intervention, and
3. Neonatal morbidity
This trial will also explore women's experience of foetal monitoring modalities.
Ethics approval
1. Regional Ethics Committee - Health Services Executive, North Eastern Region (Ireland), July 2007
2. Faculty of Health Sciences, Trinity College Dublin, Research Ethics Committee, November 2007
3. Coombe Women and Infant's University Hospital, Dublin, Research Ethics Committee, February 2008
Study design
Multicentre two-group randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not yet available in web format as of 21/02/2008, please use the contact details below to request a patient information sheet
Condition
Intrapartum asphyxia
Intervention
1. Control: 20 minute CTG on admission to labour ward/assessment room with signs of labour
2. Intervention: intermittent auscultation of the foetal heart, on admission to the labour ward/assessment room with signs of labour, using a Pinard stethoscope or a Doppler ultrasound device
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Incidence of caesarean section, measured at or immediately after birth.
Secondary outcome measures
1. Obstetric intervention to include:
1.1. Use of continuous EFM
1.2. Use of foetal blood sampling
1.3. Augmentation of labour with oxytocin
1.4. Augmentation of labour with artificial rupture of membranes (ARM)
1.5. Artificial rupture of membranes
1.6. Labour length
1.7. Epidural analgesia
1.8. Episiotomy
1.9. Opiate analgesia
1.10. Perineal trauma requiring repair (excluding episiotomy)
1.11. Estimated blood loss
1.12. Mode of birth
2. Neonatal morbidity to include:
2.1. Metabolic acidosis (defined as an umbilical artery blood pH less than 7.05, and a base deficit in the extracellular fluid compartment (BD) of greater than 12.0 mmol/l)
2.2. Hypoxic ischaemic encephalopathy (HIE)
2.3. Seizures
2.4. Use of anticonvulsants
2.5. Hypotonia
2.6. Apgar scores at one and five minutes
2.7. Admission to the Neonatal Intensive Care Unit (NICU)
2.8. Length of stay in NICU (in days)
2.9. Length of neonatal ventilator days
2.10. Neonatal death
2.11. Stillbirth
2.12. Intracranial haemorrhage
2.13. Meconium aspiration
2.14. Renal failure
2.15. Neonatal resuscitation
3. Women's experience of foetal monitoring modalities
All outcomes will be measured at or immediately after birth except for the qualitative interviews which will be carried out 6 - 8 weeks post birth.
Overall trial start date
10/03/2008
Overall trial end date
10/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women between 37+0 and 40+6 completed weeks of pregnancy
2. Absence of antenatal, maternal and foetal risk factors to the development of neonatal encephalopathy, cerebral palsy or perinatal death as per RCOG, which warrant EFM
3. Greater than or equal to18 years
4. Ability to understand study information and willingness to give written, informed consent
5. Women participating in interviews must be able to converse in English
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
5,776 (2,888 per group)
Participant exclusion criteria
Any criteria that does not meet the inclusion criteria.
Recruitment start date
10/03/2008
Recruitment end date
10/06/2010
Locations
Countries of recruitment
Ireland
Trial participating centre
National University of Ireland
Galway
-
Ireland
Sponsor information
Organisation
Health Research Board (HRB) (Ireland)
Sponsor details
73 Lower Baggot Street
Dublin
2
Ireland
+353 (0)1 234 5000
hrb@hrb.ie
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Board (HRB) (Ireland) (ref: RP/2006/55)
Alternative name(s)
HRB
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Ireland
Funder name
Department of Health and Children (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 recruitment rates results in: http://www.ncbi.nlm.nih.gov/pubmed/25958221