Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn Infant Clinical Trial
— INFANTOfficial title:
A Multicentre Randomised Controlled Trial of an Intelligent System to Support Decision Making in the Management of Labour Using the Cardiotocogram
| NCT number | NCT02010710 |
| Other study ID # | 06/38/01 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 6, 2010 |
| Est. completion date | May 2014 |
| Verified date | October 2018 |
| Source | University College, London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In women judged to require continuous electronic fetal heart rate monitoring (EFM) during their labour, does the addition of decision support software to aid the interpretation of the intrapartum cardiotocogram (CTG) reduce the number of 'poor neonatal outcomes'? This study is not introducing a new form of labour monitoring; it is evaluating the addition of decision-support to CTGs displayed on the Guardian™ system. Specifically comparing: "No decision-support" - CTGs with no additional interpretation (UK standard care), compared with: "Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time. How the labour is managed is entirely up to the recruiting unit and the woman; however the allocation of decision-support or no decision-support is determined randomly by the Guardian™ system.
| Status | Completed |
| Enrollment | 47062 |
| Est. completion date | May 2014 |
| Est. primary completion date | August 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 16 Years and older |
| Eligibility |
Inclusion Criteria: - Require continuous electronical fetal monitoring during labour - they have a singleton or twin pregnancy - they are = 35 weeks' gestation (= 245 days) - there is no known gross fetal abnormality, including any known fetal heart arrhythmia such as heart block - they are 16 years of age or older - they are able to give consent to participate in the trial as judged by the attending clinicians. Exclusion Criteria: - • triplets or higher order pregnancy - criteria for EFM not met, including elective caesarean section prior to the onset of labour |
| Country | Name | City | State |
|---|---|---|---|
| Ireland | Rotunda | Dublin | |
| United Kingdom | Birmingham Women's Hospital | Birmingham | |
| United Kingdom | Royal Bolton Hospital | Bolton | |
| United Kingdom | Lancashire Women's and Newborn Centre | Burnley | Lancs |
| United Kingdom | University Hospitals Coventry & Warwick | Coventry | |
| United Kingdom | Royal Derby Hospital | Derby | |
| United Kingdom | Princess Royal | Glasgow | |
| United Kingdom | Southern General | Glasgow | |
| United Kingdom | Liverpool Women's Hospital | Liverpool | |
| United Kingdom | Chelsea and Westminster Hospital | London | |
| United Kingdom | Homerton University Hospital | London | |
| United Kingdom | Northwick Park Hospital | London | |
| United Kingdom | St Mary's Hospital | Manchester | |
| United Kingdom | Nottingham City/Queens Medical Centre | Nottingham | |
| United Kingdom | Derriford Hospital | Plymouth | |
| United Kingdom | Queen Alexandra | Portsmouth | |
| United Kingdom | Princess Anne | Southampton | |
| United Kingdom | Stoke Mandeville Hospital | Stoke Mandeville | |
| United Kingdom | University Hospital North Staffs | Stoke-on-Trent | |
| United Kingdom | Warrington Hospital | Warrington | |
| United Kingdom | Warwick Hospital | Warwick |
| Lead Sponsor | Collaborator |
|---|---|
| University College, London | K2 Medical Systems, National Childbirth Trust, University of Birmingham, University of Leicester, University of Oxford, University of Plymouth |
Ireland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Infant outcomes | Metabolic acidosis defined as a cord-artery pH <7.05 (this is 2 standard deviations below the mean) with base deficit = 12 mmol/l (this is a threshold above which the risks of neurological damage increase) The distribution of cord-blood gas data for cord-artery pH Apgar score <4 at 5 minutes Intrapartum stillbirth Neonatal death Seizures Resuscitation interventions Admissions to neonatal unit within 48 hours of birth for at least 48 hours Admissions to neonatal unit within 48 hours of birth for at least 48 hours with evidence of: Encephalopathy Feeding difficulties Respiratory illness Admission to a higher level of care In the sub-set of 7,000 surviving children without any degree of encephalopathy and agreed to be followed-up at age 2 years: PARCA-R composite score Cerebral palsy - (determined by asking the parents if their child has Cerebral palsy) Late deaths (after the neonatal period) General health issues at 2 years |
during admission and at 2 years | |
| Other | Mother | Mode of delivery Any operative intervention (caesarean section and instrumental delivery) for i. fetal distress, or ii. failure to progress, or iii. combination of fetal distress and failure to progress iv. other reason Any episode of fetal blood sampling Episiotomy Grade of caesarean section Length of first stage, length of second stage, total length of labour from trial entry |
during admission | |
| Primary | Admissions to higher level of care | A composite of 'poor perinatal outcome' to include (a) all deaths (intrapartum stillbirths plus neonatal deaths i.e. deaths up to 28 days after birth) except deaths due to congenital anomalies, (b) significant morbidity: neonatal encephalopathy (moderate and severe); (c) admissions to the neonatal unit within 48 hours of birth for = 48 hrs with evidence of feeding difficulties, respiratory illness or encephalopathy. | within 48 hours and for longer than 48 hours | |
| Secondary | Neuro Development | PARCA-R composite score at the age of two years | 2 years |