An interventional study of Visual biofeedback in Labor Long and Labour;Obstructed, sponsored by Assuta Ashdod Hospital. Completed at 1 site in Israel. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by Assuta Ashdod Hospital · Not applicable, Interventional, and Treatment
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.
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's enrollment of 100 is below the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Assuta Ashdod Hospital is the lead sponsor of 16 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Contraindication
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Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patient will be instructed to bear down during 4 consecutive contractions while monitoring head descent using transperineal ultrasound. In the study group, patients will observe the descent of the head during contraction on the ultrasound display screen.
Other: Visual biofeedback
The patient will be instructed to bear down during 4 consecutive contractions while monitoring head descent using transperineal ultrasound. In the control group, patients will not observe the ultrasound display screen.
Patient will observe the descent of the fetal head as they push during contractions
Duration of the second stage of labor
Minutes from first documentation of full dilatation to delivery.
Time frame: Up to 6 hours
Mode of delivery
Mode of delivery (categorical): spontaneous vaginal, operative vaginal or cesarean
Time frame: Up to 6 hours
Neonatal 1 minute Apgar score
Apgar score at 1 minute after delivery (scale of 0-10)
Time frame: Up to 6 hours
Neonatal 5 minute Apgar score
Apgar score at 5 minute after delivery (scale of 0-10)
Time frame: Up to 6 hours
Cord pH
Umbilical cord blood pH
Time frame: Up to 6 hours
Postpartum hemorrhage
Rate of early postpartum hemorrhage (during first 24 hours)
Time frame: Up to 24 hours
Maternal perineal tears
Maternal perineal tear grade (categorical): None and grades 1-4
Time frame: Up to 6 hours
Plan to share: No
Ran from Apr 2020 to primary completion in Nov 2022, 30 months.
Of 18 interventional studies with no phase under Dystocia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 40. This study's 30 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Assuta Ashdod Hospital