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

Completed

• Conditions: Failed Labor
• Interventions: Procedure: ultrasound examination

• Registration Number: NCT01610453
• Lead Sponsor: Helse Stavanger HF

Brief 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).

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-06-01
• Study First Posted: 2012-06-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2016-04
• Results First Submitted: 2016-04-25
• Results First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-26
• Results First Posted: 2016-04-27
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Primiparous women with single pregnancies and gestation age > 37 weeks and prolonged first stage of labor

Exclusion Criteria

• High risk pregnancies,
• premature deliveries,
• multiple pregnancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ultrasound	ultrasound examination	primiparous women with prolonged labours will be eligible for examination

Primary Outcome Measures

Name	Time	Method
Percentage of Women With Vaginal Deliveries	active labor	Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance (HPD) ≤40 mm and angle of progression (AoP) ≥110 degrees were used as cut-off level. HPD was obtained in all 150 cases and AoP was successfully obtained in 145 cases.

Secondary Outcome Measures

Name	Time	Method
Percentage of Women With Cesarean Section	active labor	The percentage of women with cesarean section was compared in cases with occiput posterior position and cases with non occiput posterior position assessed with transabdominal sonography when prolonged labor was diagnosed.

Trial Locations

Locations (6)

Stavanger University Hospital; 🇳🇴 Stavanger, Norway

St.Olavs Hospital; 🇳🇴 Trondheim, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom

Hvidovre Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark

Skåne University Hospital; 🇸🇪 Malmø, Sweden