Clinical trial NCT01610453: Prediction of Delivery With Transperineal Ultrasound in Women With Prolonged Labour. Multicentre Study
Official title: Prediction of Mode of Delivery With Transperineal Ultrasound in Women With Prolonged First Stage of Labour. A Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Failed Labor
Keywords: prolonged labor
cesarean section
duration of labor
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Norwegian University of Science and Technology
name: Haukeland University Hospital
name: Skane University Hospital
name: Hvidovre University Hospital
name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2012-06-04
Enrollment: 150
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 48
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primiparous women in labor

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).

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

Primary outcomes:
measure: Percentage of Women With Vaginal Deliveries
timeFrame: active labor
Secondary outcomes:
measure: Percentage of Women With Cesarean Section
timeFrame: active labor
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital
state: Hvidovre
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Trondheim
country: Norway
facility: St.Olavs Hospital
city: Malmø
country: Sweden
facility: Skåne University Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Torbjørn M Eggebø, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.