Ultrasound Prediction of Prolonged Labour
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|ClinicalTrials.gov Identifier: NCT00915148|
Recruitment Status : Completed
First Posted : June 5, 2009
Results First Posted : April 26, 2016
Last Update Posted : April 26, 2016
|Condition or disease||Intervention/treatment|
|Prolonged Labor||Other: 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.
|Study Type :||Observational|
|Actual Enrollment :||110 participants|
|Official Title:||First Stage 3D-ultrasound During Prolonged Labour.|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
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
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|