Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04635410
Status:
RECRUITING
Last Update Posted:
2021-09-05
First Post:
2020-11-12
Brief Title:
Improving Ultrasound Based Prediction of Delivery Mode
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Ultrasound Prediction of Delivery Mode Can the First Stage Prediction Model be Further Improved
Status:
RECRUITING
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The progress of labour is traditionally determined by regular vaginal examinations VEs to assess the cervix neck of the womb and the babys head position Such examinations can be uncomfortable and risk causing infection to the baby or mothers 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 womans 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
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 womans 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None