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NO CONDITIONSNCT04635410

Improving Ultrasound Based Prediction of Delivery Mode

An observational study of NO CONDITIONS, run by Imperial College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 44 years, women onlyHealthy volunteers can take part
Conditions the study is for
NO CONDITIONS
What is being tested?
ULTRASOUND IMAGING
How many people
240 participants
Where
1 siteUnited Kingdom
Study dates
3 Feb 2020to Feb 2025
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Recruitment will start upon approval of the study. The infrastructure, research fellow, ultrasound machines, and the database are already in place, which ensure that the study can start promptly upon approval, without affecting or compromising routine clinical service provision. We aim to recruit minimum number according to the following calculations: In the labour prediction model, there are approximately 12 variables with 10 patients needed per variable and an approximate 25% Caesarean section rate (the primary outcome) in the UK currently. Practical calculation: 12 x 10 x (100/25) = 480 patients For predictive modelling, 480 patients minimum are required (37- 42 weeks). We have recruited 269 patients in the previous study, therefore, approximately 211 fully evaluable patients will be needed. We intend to recruit 240 participants to allow approximately 10% incomplete data/study withdrawals

Who may be able to join

  • Aged 18-44.
  • Cephalic presentation.
  • Nulliparous.
  • Singleton.

Who cannot join

  • Younger than 18 years.
  • Life-threatening maternal or fetal compromise needing immediate medical attention and/or delivery.
  • Women who in the opinion of the researcher are unable to give fully informed consent to the study.
  • Non-cephalic presentations.
  • Multiple pregnancies.
  • Multiparous patients.
  • Not in established labour

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • Imperial college NHS Trust Queen Charlotte and Chelsea Hospital

    London

    Christoph Lees, Professor, +44 (0)208 383 3572, christoph.lees@nhs.net

    Recruiting

Other trials in United Kingdom

About this study

Official title: Ultrasound Prediction of Delivery Mode: Can the First Stage Prediction Model be Further Improved?

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.

Read more

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.
Read the 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.

Conditions
NO CONDITIONS
Being tested
ULTRASOUND IMAGING
Keywords
NO CONDITIONS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ULTRASOUND IMAGINGOther

    SCAN LABOURING WOMEN BY ULTRASOUND

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intrapartum Caesarean delivery (ICD)

    Number of participants who delivered by Caesarean section

    Measured: 3 years

Secondary outcomes (1)
  1. Time to delivery (length of labour of onset of the first stage to the completion of the second stage).

    Number of hours from the onset of labour to the end of the second stage

    Measured: 12-24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2020
  2. Study start3 Feb 2020
  3. Primary completionFeb 2025 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
240 participants (estimated)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT04635410
Sponsor's protocol ID
283692
Status last verified
Sep 2021
First submitted
12 Nov 2020
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of NO CONDITIONS, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intrapartum Caesarean delivery (ICD) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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