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

Failed Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610453
• Other study ID #: REK2011/731
• Secondary ID: susID155
• Status: Completed
• Phase: N/A
• First received: February 10, 2012
• Last updated: April 26, 2016
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2016
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 48 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Failed Labor

Intervention

Procedure:
• ultrasound examination
transabdominal and transperineal ultrasound examinations

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Copenhagen	Hvidovre
Norway	Haukeland University Hospital	Bergen
Norway	Stavanger University Hospital	Stavanger
Norway	St.Olavs Hospital	Trondheim
Sweden	Skåne University Hospital	Malmø
United Kingdom	Addenbrooke's Hospital	Cambridge

Sponsors (6)

Lead Sponsor	Collaborator
Helse Stavanger HF	Cambridge University Hospitals NHS Foundation Trust, Haukeland University Hospital, Hvidovre University Hospital, Norwegian University of Science and Technology, Skåne University Hospital

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden,  United Kingdom, 

References & Publications (5)

Akmal S, Tsoi E, Kametas N, Howard R, Nicolaides KH. Intrapartum sonography to determine fetal head position. J Matern Fetal Neonatal Med. 2002 Sep;12(3):172-7. — View Citation

Barbera AF, Pombar X, Perugino G, Lezotte DC, Hobbins JC. A new method to assess fetal head descent in labor with transperineal ultrasound. Ultrasound Obstet Gynecol. 2009 Mar;33(3):313-9. doi: 10.1002/uog.6329. — View Citation

Eggebø TM, Hassan WA, Salvesen KÅ, Lindtjørn E, Lees CC. Sonographic prediction of vaginal delivery in prolonged labor: a two-center study. Ultrasound Obstet Gynecol. 2014 Feb;43(2):195-201. doi: 10.1002/uog.13210. Epub 2013 Dec 22. — View Citation

Eggebø TM, Hassan WA, Salvesen KÅ, Torkildsen EA, Østborg TB, Lees CC. Prediction of delivery mode by ultrasound-assessed fetal position in nulliparous women with prolonged first stage of labor. Ultrasound Obstet Gynecol. 2015 Nov;46(5):606-10. doi: 10.10 — View Citation

Torkildsen EA, Salvesen KÅ, Eggebø TM. Prediction of delivery mode with transperineal ultrasound in women with prolonged first stage of labor. Ultrasound Obstet Gynecol. 2011 Jun;37(6):702-8. doi: 10.1002/uog.8951. Epub 2011 May 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Women With Vaginal Deliveries	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.	active labor	No
Secondary	Percentage of Women With Cesarean Section	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.	active labor	No