A randomised controlled trial comparing the effect of ADmission Cardiotocography versus intermittent Auscultation of the foetal heart Rate on low-risk women on admission to labour ward showing signs of possible labour

ISRCTN	ISRCTN96340041
DOI	https://doi.org/10.1186/ISRCTN96340041
Protocol serial number	RP/2006/55
Sponsor	Health Research Board (HRB) (Ireland)
Funders	Health Research Board (HRB) (Ireland) (ref: RP/2006/55), Department of Health and Children (Ireland)

Submission date: 20/02/2008
Registration date: 25/03/2008
Last edited: 11/05/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Declan Devane
Scientific

School of Nursing & Midwifery
National University of Ireland
Galway
-
Ireland

Email	Declan.Devane@nuig.ie

Study information

Primary study design	Interventional
Study design	Multicentre two-group randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Foetal cardiotocography versus intermittent auscultation during labour ward admission: a randomised controlled trial and qualitative follow-up
Study acronym	ADCAR
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Incidence of caesarean section, measured at or immediately after birth.
Key secondary outcome measure(s)	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.
Completion date	10/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	5776
Key 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
Key exclusion criteria	Any criteria that does not meet the inclusion criteria.
Date of first enrolment	10/03/2008
Date of final enrolment	10/06/2010

Locations

Countries of recruitment

Ireland

Study participating centre

National University of Ireland

Galway
-
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	recruitment rates results	10/05/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes