MedTrace Logo

Improving Ultrasound Based Prediction of Delivery Mode

NCT04635410 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2021-09-05

No results posted yet for this study

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

Interventions

OTHER

ULTRASOUND IMAGING

SCAN LABOURING WOMEN BY ULTRASOUND

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635410 on ClinicalTrials.gov