Can Ultrasound Predict Labor Outcome in Operative Vaginal Deliveries?

October 26, 2016 updated by: Helse Stavanger HF

To assess whether ultrasound methods can predict outcome of operative vaginal deliveries in nulliparous women at term with singleton pregnancies and prolonged second stage of labor.

To compare different ultrasound assessments Compare digital assessments and ultrasound findings. Investigate if movement of the fetal head during active pushing is a predictive factor

Null hypotheses:

  • Ultrasound measurements cannot predict outcomes of operative vaginal delivery.
  • Ultrasound is not better than digital examination in predicting delivery outcome.
  • Movement of fetal head with active pushing is not a predictive factor.

Study Overview

Status

Completed

Conditions

Detailed Description

The physician responsible for the labor will perform digital examinations (fetal station and position and cervical dilatation). Fetal station will be related to the ischial spine from -5 to +4 as described by WHO and illustrated in Figure 111. Another obstetrician or midwife blinded to the results from the clinical examination will perform the ultrasound measurements. The physician responsible for the labor will be blinded to the ultrasound measurements.

Ultrasound examinations between contractions

Due to considerations described below, only one recording/acquisition will be performed of each of the following:

A) Head position B) Head-perineum distance C) Midline angle D) Angle of progression E) 3D sagittal transperineal acquisition In addition single scans are performed during active pushing as described under B) and D) (and a 3D sagittal scan when possible).

A) Head position Position will be assessed in 2D with a transabdominal scan as described by Akmal4 and 3D in a transperineal scan as described by Ghi et al22. Fetal head position will be recorded as a clock dividing the circle in 24 divisions

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.

Head-perineum distance will be assessed with transperineal ultrasound. The women will be examined lying flat (or almost flat) in bed with flexed hips and knees position. The bladder should be emptied immediately before the ultrasound examination.

Head-perineum distance will be measured as the shortest distance between the outer bony limit of the fetal skull and the perineum with a transabdominal transducer placed transperineally between the labia in a transverse view (posterior fourchette - posterior commissure of the labia minor)

Midline angle will be measured as described by Ghi22. In a transverse transperineal scan the angle between the midline of the fetal head and a sagittal line through the maternal pelvis will be measured. This recording will also be performed in a transverse scan.

Angle of progression will be measured as described by Barbera and Kalache as the angle between the long axis of the symphysis pubis and the tangent of the skull in a transperineal sagittal scan.

The following outcome variables will be recorded upon delivery Main outcome

  • Time from start of vacuum assisted traction to delivery (the entire body is delivered) Secondary outcomes
  • Number of contraction before delivery
  • Number of cup detachments
  • Successful/failed vaginal operative delivery
  • Forceps applied/not applied
  • Perineal tears
  • APGAR score of newborn.
  • Arterial umbilical cord blood pH and BD (base deficit) values.
  • Position at delivery

Statistics:

The time interval between start of operative vaginal delivery and delivery will be evaluated for the fetal head-perineum distance and angle of progression using survival analyses (Kaplan-Meier analyses and Cox regression analyses).

Categorical variables will be analyzed using Chi-square test and Fischer exact test, and continuous variable will be analyzed using T-test or Mann-Whitney U-test.

The predictive values for a successful operative vaginal delivery will be evaluated using receiver-operating characteristics (ROC) curves. The area under the curve (AUC, - 95% CI) is considered to have discriminatory potential if the lower limit of the CI exceeded 0.5.

Ultrasound measurements, digital assessment of station and dilatation, induction of labor, maternal age, gestational age and birth weight will be analyzed in logistic regression analyses with vaginal delivery vs. cesarean section as dependent variable.

Study Type

Observational

Enrollment (Actual)

223

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Stavanger, Norway, 4313
        • Stavanger University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Nulliparous women with a singleton live fetus in cephalic presentation at term (≥ 37 weeks) with prolonged active second stage and a clinical decision to expedite delivery by vacuum due to poor progression

Description

Inclusion Criteria:

  • prolonged second stage of labour

Exclusion Criteria:

  • Suspected asphyxia before the start of vacuum extraction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Women in active second stage of labour
Ultrasound examinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from start of vacuum assisted traction to delivery
Time Frame: Active second stage of labor to1 hour after delivery
The duration of a vacuum extraction will be measured. Therefore, the time frame is for this variable is only the second stage of labor. However, the time frame including all variables will be from the start of active second stage of labor - 1 hour after delivery.
Active second stage of labor to1 hour after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful/failed vaginal operative delivery (vaginal delivery vs. cesarean section
Time Frame: Active second stage of labour
Successful or failed operative deliveries will be recorded. The time frame is also for this variable only the second stage of labor.
Active second stage of labour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apgar score
Time Frame: first ten minutes after delivery
Apgar score is assessed after 1,5 and 10 minutes
first ten minutes after delivery
ph and base excess in umibical cord
Time Frame: first 5 minutes after delivery
blood test from the umbilical board
first 5 minutes after delivery
birth weight and head circumference
Time Frame: First hour after delivery
First hour after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

University of Bologna
Lund University Hospital
Copenhagen University Hospital, Hvidovre
University of Parma
St.Olavs Hospital, Trondheim University Hospital, Norway
Queen Charlotte's and Chelsea Hospital

Investigators

  • Principal Investigator: Torbjørn M Eggebø, PhD, Helse Stavanger HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 9, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (Estimate)

June 17, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012/1865
  • 2012/186 (Other Identifier: REK-VEST)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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