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 |
| Secondary identifying numbers | RP/2006/55 |
- 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
Scientific
School of Nursing & Midwifery
National University of Ireland
Galway
-
Ireland
| Declan.Devane@nuig.ie |
Study information
| Study design | Multicentre two-group randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant 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 |
| 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 | 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 study start date | 10/03/2008 |
| Completion date | 10/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 5,776 (2,888 per group) |
| 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
-
Ireland
Sponsor information
Health Research Board (HRB) (Ireland)
Government
Government
73 Lower Baggot Street
Dublin
2
Ireland
| Phone | +353 (0)1 234 5000 |
|---|---|
| hrb@hrb.ie | |
| Website | http://www.hrb.ie/ |
"ROR" |
https://ror.org/003hb2249 |
Funders
Funder type
Government
Health Research Board (HRB) (Ireland) (ref: RP/2006/55)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- HRB
- Location
- Ireland
Department of Health and Children (Ireland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
