Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04635410 |
| Other study ID # |
283692 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2020 |
| Est. completion date |
February 2025 |
Study information
| Verified date |
September 2021 |
| Source |
Imperial College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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, non-intrusive "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).
The study contains ultrasound and clinical assessments:
Transabdominal Ultrasound to measure: Umbilical and Middle Cerebral Artery Doppler, fetal
head position and Amniotic Fluid Index (AFI).
Transperineal Ultrasound to assess: Head Perineum Distance (HPD), Caput Succedaneum and
moulding.
Digital vaginal examination by a caregiver: to measure cervical dilatation.
Primary outcome:
• Mode of delivery
Secondary outcome:
• Time to delivery
Neonatal outcomes:
• Apgar score, cord pH level, gender, fetal birth weight, neonatal unit admission within 24
hours, neonatal morbidity.
Description:
Intrapartum Caesarean Delivery (ICD) in advanced labour has a greater fetal and maternal
morbidity and mortality than an elective prelabour Caesarean delivery. The prediction of
delivery mode may reduce the likelihood of intrapartum Caesarean delivery. There is also a
parental desire to know the likelihood of vaginal delivery. Women admitted to delivery units
throughout the world undergo internal digital vaginal examination (DVE) when they are thought
to be in labour or where a diagnosis of labour needs to be discounted. DVE is an
uncomfortable experience, multiple examinations have been linked to ascending maternal and
fetal infection, and it is subjective method and not reliable technique to assess labour
progress.
It has recently become possible to make assessments more objectively using ultrasound.
Ultrasound in labour (intrapartum ultrasound) has come to the forefront in the last decade
stemming from a persistent demand for a more reliable method of labour assessment coupled
with a wider availability of ultrasound on the delivery suite.
The hypothesise in this study, that developing the previously derived proof of principle
labour prediction model for nulliparous women and using an additional data could improve the
prediction accuracy of intrapartum Caesarean delivery by developing a robust model.
Using the additional data gathered in term nulliparous patients, will develop the model to
predict pregnancy outcomes. This may aid in delivery of care to pregnant women by providing a
real-time online calculation tool for the likelihood of Caesarean delivery and length of
labour based on repeat ultrasound measurements.
All participants will be identified by the researcher and an emphasis will be placed on
recruiting patients antenatally as much as possible. All participating patients will be
consented prior to enrolment and will receive a full explanatory information leaflet. If
recruited antenatally, there is no time limit until the woman enters the delivery unit. If
recruited in labour, then 2 hours will be considered appropriate to make a decision on
whether they wish to take part and patient will only be approached when relatively pain-free
(in between contractions).
The admission ultrasound scan will include if feasible fetal Doppler assessment of the
Umbilical Artery (Umb A) and Middle Cerebral Artery (MCA). Amniotic Fluid Index (AFI) will
also be measured. The fetal position will be assessed with a transabdominal scan and
recorded.
Firstly, Umb A and MCA Doppler in addition to the fetal position and AFI, will be assessed
with a transabdominal scan. After that, the transducer will be placed transperineally at the
level of the posterior fourchette in a transverse position to measure HPD while caput
succedaneum will be measured in a sagittal transperineal scan. The moulding will be assessed
as either present or not.
During the ultrasound examination, women will be in the supine position with flexed hips and
knees and the bladder empty as previously described. Healthcare professionals will be blinded
to the ultrasound findings, and these findings will also not be disclosed to the parents.
Another doctor or midwife will perform all the ultrasound examinations. Subsequent scans will
be performed as required at the time of routine clinical examinations typically between 2-4
hours apart but it may be longer.
The healthcare professional will perform DVE for assessment of cervical dilatation in line
with the National Institute of Health and Clinical Excellence (NICE) guidelines.
