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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01610453
Enrollment
150
Registered
2012-06-04
Start date
2012-01-31
Completion date
2013-04-30
Last updated
2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Labor

Keywords

prolonged labor, cesarean section, duration of 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).

Interventions

PROCEDUREultrasound examination

transabdominal and transperineal ultrasound examinations

Sponsors

Norwegian University of Science and Technology
CollaboratorOTHER
Haukeland University Hospital
CollaboratorOTHER
Skane University Hospital
CollaboratorOTHER
Hvidovre University Hospital
CollaboratorOTHER
Cambridge University Hospitals NHS Foundation Trust
CollaboratorOTHER
Helse Stavanger HF
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 48 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Women With Vaginal Deliveriesactive laborWomen 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

MeasureTime frameDescription
Percentage of Women With Cesarean Sectionactive laborThe 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.

Countries

Denmark, Norway, Sweden, United Kingdom

Participant flow

Recruitment details

Recruitment was from 1. January 2012 until 30. April 2013

Participants by arm

ArmCount
Transperineal Ultrasound
Fetal head descent was assessed using a transperineal scan
150
Total150

Baseline characteristics

CharacteristicTransperineal Ultrasound
Age, Continuous29 years
Region of Enrollment
Norway
87 participants
Region of Enrollment
United Kingdom
63 participants
Sex: Female, Male
Female
150 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 150
serious
Total, serious adverse events
0 / 150

Outcome results

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.

Time frame: active labor

Population: AoP could not be measured in 5 cases because only a part of the symphysis was visualized.

ArmMeasureGroupValue (NUMBER)
Transperineal UltrasoundPercentage of Women With Vaginal DeliveriesVaginal deliveries if HPD was ≤40 mm (n=84)92 percentage of participants in each group
Transperineal UltrasoundPercentage of Women With Vaginal DeliveriesVaginal deliveries if HPD was >40 mm (n=66)52 percentage of participants in each group
Transperineal UltrasoundPercentage of Women With Vaginal DeliveriesVaginal deliveries if AoP was ≥110 degrees (n=84)88 percentage of participants in each group
Transperineal UltrasoundPercentage of Women With Vaginal DeliveriesVaginal deliveries if AoP was <110 degrees (n=61)57 percentage of participants in each group
Comparison: Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance ≤40 mm was used as cut-off level. Vaginal delivery was the primary outcome measure.p-value: <0.01Chi-squared
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.

Time frame: active labor

Population: Fetal head position was assessed successfully using transabdominal ultrasound in 142/150 women. Position could not be diagnosed in eight cases due to shadowing from maternal pelvis in cases at low stations.

ArmMeasureGroupValue (NUMBER)
Transperineal UltrasoundPercentage of Women With Cesarean SectionCesarean section in cases with OP position (n=50)38 percentage of participants in each group
Transperineal UltrasoundPercentage of Women With Cesarean SectionCesarean sin cases with non-OP position (n=92)17 percentage of participants in each group
p-value: 0.01Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026