Condition category
Pregnancy and Childbirth
Date applied
20/02/2008
Date assigned
25/03/2008
Last edited
11/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.hrb.ie/

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

Results - basic reporting

Publication summary

2015 recruitment rates results in: http://www.ncbi.nlm.nih.gov/pubmed/25958221

Publication citations

Additional files

Editorial Notes