Improving Ultrasound Based Prediction of Delivery Mode

NCT04635410 | Unknown

• 1 other identifier: 283692
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NO CONDITIONS

Keywords

NO CONDITIONS

Outcome Measures

Primary Outcomes (1)

• Intrapartum Caesarean delivery (ICD)

  Number of participants who delivered by Caesarean section

  3 years

Secondary Outcomes (1)

• Time to delivery (length of labour of onset of the first stage to the completion of the second stage).

  12-24 hours

Interventions

ULTRASOUND IMAGING OTHER

SCAN LABOURING WOMEN BY ULTRASOUND

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: LABOURING WOMEN
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial college NHS Trust Queen Charlotte and Chelsea Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 19, 2020
• Study Start: February 3, 2020
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

GB (1)