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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

Foetal cardiotocography versus intermittent auscultation during labour ward admission: a randomised controlled trial and qualitative follow-up

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN96340041
Enrollment
5776
Registered
2008-03-25
Start date
2008-03-10
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrapartum asphyxia Pregnancy and Childbirth Intrapartum asphyxia

Interventions

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 ro

Sponsors

Health Research Board (HRB) (Ireland)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Any criteria that does not meet the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
Incidence of caesarean section, measured at or immediately after birth.

Secondary

MeasureTime frame
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.

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026