Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Ultrasound Prediction of Prolonged Labour

This study has been completed.
Information provided by (Responsible Party):
Helse Stavanger HF Identifier:
First received: June 3, 2009
Last updated: April 25, 2016
Last verified: April 2016
This observational study is designed to correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically, the study will evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.

Condition Intervention
Prolonged Labor
Other: Ultrasound examination

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: First Stage 3D-ultrasound During Prolonged Labour.

Resource links provided by NLM:

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound [ Time Frame: 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.

Secondary Outcome Measures:
  • Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations) [ Time Frame: 6 hours post determination of prolonged labor ]

Enrollment: 110
Study Start Date: November 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ultrasound examination
Women with prolonged Labour; Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.
Other: Ultrasound examination
Trans-abdominal and trans-perineal 3D ultrasound examination

Detailed Description:


To correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.


Labours have traditionally been evaluated by manuals methods of the "delivery helper" - midwives or doctor. There are many factors that will prolong labour such as malcontractions, disproportion of the birth canal and malpresentation/position. In about 20% of primigravidae, the first stage will last longer than 10 hours.

In this study we want to evaluate different ultrasounds measurements to see if ultrasound can be used to predict the outcome of labour.


A descriptive observational study, with one ultrasound examination. The labour will be handled according to definitions by Woman's department, Stavanger University Hospital, and WHO.

The use of stimulating agents, as Oxytocin, will be evaluated after manual examinations, specific definitions and criteria.

The results of the ultrasound examinations will be evaluated after the delivery, since the results are not to be used clinically during the delivery.

Inclusion criteria will be primigravidae, with one fetus, after the 37th week. Feta head presentation. Ruptured membranes, at least one hour before inclusion. Prolonged first stage according to WHO definitions. The target is to include 100 subjects.

Inter- and intraobserver variation will be evaluated with intraclass coefficients. We will analyze operative delivery with normal vaginal delivery. Also, two groups divided by the stage 0 will be evaluated with statistics analyzes.

Time to delivery will be evaluated with Kaplan Meier and Cox regression analyzes.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primi gravidae, with one fetus, after the 37th week. Cephalic presentation. Prolonged first stage according to WHO definitions.

Inclusion Criteria:

  • Primi gravidae
  • >37th week
  • Cephalic presentation
  • Prolonged first stage according to WHO definitions.

Exclusion Criteria:

  • Multiple pregnancies
  • Intrauterine fetal death
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00915148

Stavanger University Hospital
Stavanger, Norway, NO-4011
Sponsors and Collaborators
Helse Stavanger HF
Principal Investigator: Erik Andreas Torkildsen, MD Helse Stavanger HF
Study Director: Torbjørn Moe Eggebø, MD, PhD Helse Stavanger HF
  More Information


Responsible Party: Helse Stavanger HF Identifier: NCT00915148     History of Changes
Other Study ID Numbers: StaHF500804
Study First Received: June 3, 2009
Results First Received: August 21, 2015
Last Updated: April 25, 2016

Keywords provided by Helse Stavanger HF:
Prolonged labor
Caeserian section processed this record on April 28, 2017