Trial Outcomes & Findings for Prediction of Delivery With Transperineal Ultrasound in Women With Prolonged Labour. Multicentre Study (NCT NCT01610453)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

150 participants

Primary outcome timeframe

active labor

Results posted on

2016-04-27

Participant Flow

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

Participant milestones

Participant milestones
Measure	Results From Transperineal Scan Primiparous women with prolonged labours was eligible for the study. Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK and Department of Obstetrics and Gynecology, Stavanger University Hospital, Stavanger, Norway participated. Ultrasound examination: a transperineal sonography was done when prolonged labor was diagnosed. Prolonged labor was diagnosed in accordance with WHO recommendations in Stavanger and in accordance with NICE guidelines in Cambridge
Overall Study STARTED	150
Overall Study COMPLETED	150
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transperineal Ultrasound n=150 Participants Fetal head descent was assessed using a transperineal scan
Age, Continuous	29 years n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Norway	87 participants n=5 Participants
Region of Enrollment United Kingdom	63 participants n=5 Participants

PRIMARY outcome

Timeframe: active labor

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

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.

Outcome measures

Outcome measures
Measure	Transperineal Ultrasound n=150 Participants Fetal head descent was assessed using a transperineal scan
Percentage of Women With Vaginal Deliveries Vaginal deliveries if HPD was ≤40 mm (n=84)	92 percentage of participants in each group Interval 84.0 to 96.0
Percentage of Women With Vaginal Deliveries Vaginal deliveries if HPD was >40 mm (n=66)	52 percentage of participants in each group Interval 40.0 to 63.0
Percentage of Women With Vaginal Deliveries Vaginal deliveries if AoP was ≥110 degrees (n=84)	88 percentage of participants in each group Interval 79.0 to 93.0
Percentage of Women With Vaginal Deliveries Vaginal deliveries if AoP was <110 degrees (n=61)	57 percentage of participants in each group Interval 45.0 to 69.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Transperineal Ultrasound n=142 Participants Fetal head descent was assessed using a transperineal scan
Percentage of Women With Cesarean Section Cesarean section in cases with OP position (n=50)	38 percentage of participants in each group
Percentage of Women With Cesarean Section Cesarean sin cases with non-OP position (n=92)	17 percentage of participants in each group

Adverse Events

Transabdominal and Transperineal Sonography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Torbjørn Moe Eggebø

Stavanger UH

Phone: +4792699433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place