Improving ultrasound based prediction of delivery mode

• Research type

  Research Study

• Full title

  Ultrasound Prediction of Delivery Mode: can the first stage prediction model be further improved?

• IRAS ID

  283692

• Contact name

  Christoph Lees

• Contact email

  christoph.lees@nhs.net

• Sponsor organisation

  Imperial College London and Imperial College Healthcare NHS Trust

• Clinicaltrials.gov Identifier

  NCT04635410

• Clinicaltrials.gov Identifier

  15/LO/0227 , 15/LO/0227

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  The progress of labour is traditionally determined by regular vaginal examinations (VEs) to assess the cervix (neck of the womb) and the baby’s head position. Such examinations can be uncomfortable and risk causing infection to the baby or mother’s womb. The findings are subjective, can be unreliable and cannot be recorded for later review and analysis.

  The novel, non­intrusive “transperineal ultrasound” technique has been developed utilising existing scanning machines normally found on a delivery unit, with the ultrasound probe placed outside the woman’s vagina. This allows objective, recordable measurements creating images that can be captured and stored electronically.

  This is a prospective longitudinal observational cohort study in nulliparous term (37-42 weeks) labouring women. This study aims to improve the prediction of intrapartum Caesarean Delivery (ICD).

  OUTCOME MEASURES:

  Dataset for a predictive model of outcome of labour of intrapartum Caesarean Delivery (ICD). Ultrasound and clinical assessments by:

  Transabdominal Ultrasound: Umbilical and Middle Cerebral Artery Doppler, fetal head position and Amniotic Fluid Index (AFI).

  Transperineal Ultrasound: Head Perineum Distance (HPD), Caput Succedaneum and moulding.

  Digital vaginal examination by a caregiver: Cervical dilatation.

  Primary outcome:
  • Mode of delivery: intrapartum Caesarean delivery

  Secondary outcome:

  • Time to delivery (length of labour of onset of the first stage to the completion of the second stage)
  • Primary indication for delivery
  o failure to progress
  o suspected fetal compromise

  Neonatal outcomes:
  • Apgar score, cord pH level, gender, fetal birth weight, neonatal unit admission within 24 hours, neonatal morbidity.

  ELIGIBILITY: all nulliparous pregnant women booked at Imperial College Healthcare NHS Trust between the ages of 18 and 44 able to give consent.

  DURATION: the duration of the study is 3 years.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  20/EM/0298

• Date of REC Opinion

  5 Feb 2021

• REC opinion

  Further Information Favourable Opinion