Prolonged Labor Clinical Trial
Official title:
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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