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

NCT ID: NCT01610453

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-04-30

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).

Conditions

Failed Labor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ultrasound

primiparous women with prolonged labours will be eligible for examination

ultrasound examination

Intervention Type: PROCEDURE

transabdominal and transperineal ultrasound examinations

Interventions

ultrasound examination

transabdominal and transperineal ultrasound examinations

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Skane University Hospital

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Torbjørn M Eggebø, PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

Hvidovre Hospital

Copenhagen, Hvidovre, Denmark

Haukeland University Hospital

Bergen, , Norway

Stavanger University Hospital

Stavanger, , Norway

St.Olavs Hospital

Trondheim, , Norway

Skåne University Hospital

Malmo, , Sweden

Addenbrooke's Hospital

Cambridge, , United Kingdom

Countries

Denmark; Norway; Sweden; United Kingdom

References

Torkildsen EA, Salvesen KA, Eggebo 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.

Reference Type: BACKGROUND

PMID: 21308837 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19248000 (View on PubMed)

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. doi: 10.1080/jmf.12.3.172.177.

Reference Type: BACKGROUND

PMID: 12530614 (View on PubMed)

Eggebo TM, Hassan WA, Salvesen KA, Lindtjorn 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.

Reference Type: RESULT

PMID: 24105705 (View on PubMed)

Eggebo TM, Hassan WA, Salvesen KA, Torkildsen EA, Ostborg 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: 10.1002/uog.14773. Epub 2015 Sep 28.

Reference Type: RESULT

PMID: 25536955 (View on PubMed)

Other Identifiers

susID155

Identifier Type: REGISTRY

Identifier Source: secondary_id

REK2011/731

Identifier Type: -

Identifier Source: org_study_id