Ultrasound Prediction of Prolonged Labour

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00915148
First received: June 3, 2009
Last updated: April 25, 2016
Last verified: April 2016

June 3, 2009
April 25, 2016
November 2008
August 2010   (final data collection date for primary outcome measure)
Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound [ Time Frame: during labor ] [ Designated as safety issue: No ]
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.
Ceasarian section [ Time Frame: Intra-labour ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00915148 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Time to delivery [ Time Frame: Intra-labour ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Ultrasound Prediction of Prolonged Labour
First Stage 3D-ultrasound During Prolonged Labour.
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.

AIM:

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.

Objective:

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.

Methods:

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Primi gravidae, with one fetus, after the 37th week. Cephalic presentation. Prolonged first stage according to WHO definitions.
Prolonged Labor
Other: Ultrasound examination
Trans-abdominal and trans-perineal 3D ultrasound examination
Ultrasound examination
Women with prolonged Labour; Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.
Intervention: Other: Ultrasound examination

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Multiple pregnancies
  • Intrauterine fetal death
Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00915148
StaHF500804
No
Not Provided
Not Provided
Helse Stavanger HF
Helse Stavanger HF
Not Provided
Principal Investigator: Erik Andreas Torkildsen, MD Helse Stavanger HF
Study Director: Torbjørn Moe Eggebø, MD, PhD Helse Stavanger HF
Helse Stavanger HF
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP