Trial Outcomes & Findings for Study of Ultrasound Imaging to Predict Time and Outcome in Pregnancies With Induced Labor (NCT NCT00465998)

Results Overview

The association between Bishop score, ultrasound assessed fetal station, ultrasound assessed cervical length, cervical posterior angle and a vaginal delivery was investigated using area under the ROC curves. Fetal station was assessed by ultrasound as the fetal head-perineum distance (HPD); which was measured by transperineal ultrasound imaging as the shortest distance from the outer bony limit of the fetal skull to the skin surface of the perineum.

Recruitment status

COMPLETED

Target enrollment

250 participants

Primary outcome timeframe

Time from induction of labor to delivery

Results posted on

2016-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	Successful Vaginal Delivery 275 women with induced labors were included in the study, and the main outcome was vaginal delivery. Variables associated to a successful vaginal delivery was examined.
Overall Study STARTED	275
Overall Study COMPLETED	275
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Ultrasound Imaging to Predict Time and Outcome in Pregnancies With Induced Labor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Time From Induction to Delivery n=275 Participants Variables associated to time from induction to delivery were investigated.
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	272 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	30 years n=5 Participants
Sex: Female, Male Female	275 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Norway	275 participants n=5 Participants

PRIMARY outcome

Timeframe: Time from induction of labor to delivery

The association between Bishop score, ultrasound assessed fetal station, ultrasound assessed cervical length, cervical posterior angle and a vaginal delivery was investigated using area under the ROC curves. Fetal station was assessed by ultrasound as the fetal head-perineum distance (HPD); which was measured by transperineal ultrasound imaging as the shortest distance from the outer bony limit of the fetal skull to the skin surface of the perineum.

Outcome measures

Outcome measures
Measure	Successful Vaginal Delivery n=275 Participants 275 women with induced labors were included in the study, and the main outcome was vaginal delivery. Variables associated to a successful vaginal delivery was examined.
Vaginal Delivery in Induced Labors Area under the ROC curve associated to HPD	62 percentage of area under the ROC curve Interval 52.0 to 71.0
Vaginal Delivery in Induced Labors Area under the curve associated to cervical length	61 percentage of area under the ROC curve Interval 51.0 to 71.0
Vaginal Delivery in Induced Labors Area under the curve associated to cervical angle	63 percentage of area under the ROC curve Interval 52.0 to 74.0
Vaginal Delivery in Induced Labors Area under the curve associated to Bishop score	60 percentage of area under the ROC curve Interval 51.0 to 69.0

SECONDARY outcome

Timeframe: Time from induction to delivery

Population: Hazard ratio was reported.

Association between parity, HPD, cervical length, cervical angle, occiput posterior position, parity, BMI and the Hazard ratio of delivering within 24 hours was investigated using Cox regression analysis.

Outcome measures

Outcome measures
Measure	Successful Vaginal Delivery n=275 Participants 275 women with induced labors were included in the study, and the main outcome was vaginal delivery. Variables associated to a successful vaginal delivery was examined.
Delivery Within 24 Hours HPD ≤ 40 mm	1.67 Hazard ratio Interval 1.23 to 2.26
Delivery Within 24 Hours Cervical length ≤ 25 mm	2.35 Hazard ratio Interval 1.75 to 3.14
Delivery Within 24 Hours Cervical posterior > 90 degrees	1.92 Hazard ratio Interval 1.22 to 3.04
Delivery Within 24 Hours Occiput posterior position	1.27 Hazard ratio Interval 0.93 to 1.75
Delivery Within 24 Hours Multiparous woman	3.25 Hazard ratio Interval 2.43 to 4.35
Delivery Within 24 Hours BMI < 30	1.14 Hazard ratio Interval 0.78 to 1.65

Adverse Events

Successful Vaginal Delivery

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Successful Vaginal Delivery n=275 participants at risk 275 women with induced labors were included in the study, and the main outcome was vaginal delivery. Variables associated to a successful vaginal delivery was examined.
Cardiac disorders maternal death	0.36% 1/275 • Number of events 1 • From start of induction to discharge from the labor ward

Other adverse events

Adverse event data not reported

Additional Information

Professor Torbjørn Moe Eggebø

Stavanger University Hospital

Phone: +4792699433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place