Assuta Ashdod Hospital
Ashdod, Israel
NCT Number: NCT04210908
The purpose of this study is to examine whether transperineal ultrasound as visual biofeedback can be used during labor as an effective tool for shortening the second stage of labor and reducing the need for instrumental delivery, in a prospective randomized design.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Ashdod, Israel
Biofeedback provides patients with better control of their body and their physiological reactions respective of the examined process, such as stress/anxiety, sports activity, labor, etc.
Women under epidural anesthesia, may frequently feel lack of control over the birthing process and difficulty in bearing down effectively, which is a very significant part of the second stage of labor.
Transperineal ultrasound during labor is a standard procedure in many medical centers in the world, mainly used to assist obstetricians in evaluating the progress of labor, fetal head position and assessing the chances of successful operative delivery. One of the most common tools used in transperineal ultrasound in measurement of the angle of progression, which has been suggested as a subjective method for assessing fetal station and for predicting successful vaginal delivery. A preliminary non-randomized study raised the possibility that the use of transperineal ultrasound during labor as a biofeedback tool may shorten the second stage of labor.
The purpose of this study is to examine whether this tool can be used during labor as an effective tool for shortening the second stage of labor and reducing the need for instrumental delivery, in a prospective randomized design.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient will observe the descent of the fetal head as they push during contractions
Time frame: Up to 6 hours
Minutes from first documentation of full dilatation to delivery.
Time frame: Up to 6 hours
Mode of delivery (categorical): spontaneous vaginal, operative vaginal or cesarean
Time frame: Up to 6 hours
Apgar score at 1 minute after delivery (scale of 0-10)
Time frame: Up to 6 hours
Apgar score at 5 minute after delivery (scale of 0-10)
Time frame: Up to 6 hours
Umbilical cord blood pH
Time frame: Up to 24 hours
Rate of early postpartum hemorrhage (during first 24 hours)
Time frame: Up to 6 hours
Maternal perineal tear grade (categorical): None and grades 1-4
Assuta Ashdod Hospital
Other
Ultrasound Imaging Biofeedback for Shortening the Second Stage of Labor: a Randomized Prospective Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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