Trial Outcomes & Findings for Ultrasound Prediction of Prolonged Labour (NCT NCT00915148)

Results Overview

Fetal Head descent was first measured as the shortest distance between the outer bony limit of the fetal skull and the Perineum. Fetal head descent was re-assessed by measuring the angle of progression in a mid-sagittal plane. Fetal head-perineum distance was evaluated with using a cut-off of ≤40 mm, while the angle of progression was evaluated using a cut off of ≥ 110 degrees. The ROC curves plotted the percentage sensitivity against the percentage false positive rate for head-perineum distance and angle of progression as measured by ultrasound.

Recruitment status

COMPLETED

Target enrollment

110 participants

Primary outcome timeframe

during labor

Results posted on

2016-04-26

Participant Flow

Medical contact during10 months

No participants were excluded

Participant milestones

Participant milestones
Measure	Women With Prolonged Labour Primi gravidae, single pregnancy, \>37 weeks, fetus alive, cephalic presentation. Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination
Overall Study STARTED	110
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound Prediction of Prolonged Labour

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women With Prolonged Labour n=110 Participants Primi gravidae, single pregnancy, \>37 weeks, fetus alive, cephalic presentation. Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	110 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29 years n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Norway	110 participants n=5 Participants

PRIMARY outcome

Timeframe: during labor

Fetal Head descent was first measured as the shortest distance between the outer bony limit of the fetal skull and the Perineum. Fetal head descent was re-assessed by measuring the angle of progression in a mid-sagittal plane. Fetal head-perineum distance was evaluated with using a cut-off of ≤40 mm, while the angle of progression was evaluated using a cut off of ≥ 110 degrees. The ROC curves plotted the percentage sensitivity against the percentage false positive rate for head-perineum distance and angle of progression as measured by ultrasound.

Outcome measures

Outcome measures
Measure	Women With Prolonged Labour n=110 Participants Primi gravidae, single pregnancy, \>37 weeks, fetus alive, cephalic presentation. Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination
Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound 2D fetal head-perineum distance (AUC)	81 percentage probability Interval 71.0 to 91.0
Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound 2D angle of progression (AUC)	76 percentage probability Interval 66.0 to 87.0
Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound 3D fetal head-perineum distance	80 percentage probability Interval 70.0 to 90.0
Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound 3D angle of progression (AUC)	76 percentage probability Interval 65.0 to 86.0

SECONDARY outcome

Timeframe: 6 hours post determination of prolonged labor

Outcome measures

Outcome measures
Measure	Women With Prolonged Labour n=110 Participants Primi gravidae, single pregnancy, \>37 weeks, fetus alive, cephalic presentation. Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination
Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations) Fetal head-perineum distance ≤40 mm (n=54)	74 percentage of participants
Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations) Fetal head-perineum distance >40 mm (n=56)	39 percentage of participants
Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations) Angle of progression ≥110 degrees (n=53)	72 percentage of participants
Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations) Angle of progression <110 degrees (n=57)	44 percentage of participants

Adverse Events

Women With Prolonged Labour

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

Torbjørn Moe Eggebø, phd

Stavanger UH

Phone: 004792699433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place