Clinical Trials Directory

Trials / Completed

CompletedNCT01610453

Prediction of Delivery With Transperineal Ultrasound in Women With Prolonged Labour. Multicentre Study

Prediction of Mode of Delivery With Transperineal Ultrasound in Women With Prolonged First Stage of Labour. A Multicentre Study

Status
Completed
Phase
Study type
Observational
Enrollment
150 (actual)
Sponsor
Helse Stavanger HF · Other Government
Sex
Female
Age
15 Years – 48 Years
Healthy volunteers
Accepted

Summary

Objectives 1. To assess if head-perineum distance and angle of progression measured with transperineal ultrasound by the obstetrician on call can predict delivery mode in primiparous women with prolonged first stage of labour. 2. To compare ultrasound assessments and clinical examinations.

Detailed description

Variables Digitally assessed cervical dilatation, fetal station and position Ultrasound measured fetal head-perineum distance. Ultrasound measured angle of progression Ultrasound assessed position Possible confounders Ethnicity, maternal age, gestational age, BMI, induction of labour, augmentation, epidural analgesia, birth weight, head circumference A two-dimensional ultrasound measurement will be obtained with the ultrasound device available in the delivery department. Fetal head descent is measured as the shortest distance between the outer bony limit of the fetal skull and the perineum with a curved transabdominal transducer placed transperineally between the labia in a transverse view (1). The fetal descent will also be assessed measuring "angle of progression" as suggested by Barbera et al. The ultrasound transducer will be placed on the perineum in a mid-sagittal position between the labia below the pubic symphysis. The angle between a line through the symphysis and a line from the posterior part of the symphysis tangentially to the fetal skull contour will be measured (2) A transabdominal scan will also be performed determining the fetal position as described previously. Positions ≥ 02.30 and ≤ 03.30 hours should be recorded as left occiput transverse and positions ≥ 08.30 and ≤ 09.30 as right occiput transverse. Positions \> 03.30 and \<08.30 should be recorded as occiput posterior and positions \> 09.30 and \< 02.30 as occiput anterior.(3).

Conditions

Interventions

TypeNameDescription
PROCEDUREultrasound examinationtransabdominal and transperineal ultrasound examinations

Timeline

Start date
2012-01-01
Primary completion
2013-04-01
Completion
2013-04-01
First posted
2012-06-04
Last updated
2016-04-27
Results posted
2016-04-27

Locations

6 sites across 4 countries: Denmark, Norway, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT01610453. Inclusion in this directory is not an endorsement.