Ultrasound and Prolonged Labour
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||First Stage 3D-ultrasound During Prolonged Labour.|
- Ceasarian section [ Time Frame: Intra-labour ] [ Designated as safety issue: Yes ]
- Time to delivery [ Time Frame: Intra-labour ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915148
|Stavanger University Hospital|
|Stavanger, Norway, NO-4011|
|Principal Investigator:||Erik Andreas Torkildsen, MD||Helse Stavanger HF|
|Study Director:||Torbjørn Moe Eggebø, MD, PhD||Helse Stavanger HF|