Study Results
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Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2020-04-30
2022-11-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Biofeedback
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.
Visual biofeedback
Patient will observe the descent of the fetal head as they push during contractions
Control
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.
No interventions assigned to this group
Interventions
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Visual biofeedback
Patient will observe the descent of the fetal head as they push during contractions
Eligibility Criteria
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Inclusion Criteria
2. Full dilation
3. Head position between SP-1 and SP+2.
4. Epidural anesthesia
5. No contraindication for vaginal delivery
6. Parturient informed consent
Exclusion Criteria
2. Category III fetal monitoring requiring immediate delivery.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Assuta Ashdod Hospital
OTHER
Responsible Party
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Eran Brazilay, MD PhD
Head of the Obstetric and Gynecologic Ultrasound unit
Principal Investigators
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Eran Barzilay, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Samson Assuta Ashdod University Hospital
Locations
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Assuta Ashdod Hospital
Ashdod, , Israel
Countries
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References
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Kalache KD, Duckelmann AM, Michaelis SA, Lange J, Cichon G, Dudenhausen JW. Transperineal ultrasound imaging in prolonged second stage of labor with occipitoanterior presenting fetuses: how well does the 'angle of progression' predict the mode of delivery? Ultrasound Obstet Gynecol. 2009 Mar;33(3):326-30. doi: 10.1002/uog.6294.
Gilboa Y, Frenkel TI, Schlesinger Y, Rousseau S, Hamiel D, Achiron R, Perlman S. Visual biofeedback using transperineal ultrasound in second stage of labor. Ultrasound Obstet Gynecol. 2018 Jul;52(1):91-96. doi: 10.1002/uog.18962. Epub 2018 May 29.
Diegmann EK, Andrews CM, Niemczura CA. The length of the second stage of labor in uncomplicated, nulliparous African American and Puerto Rican women. J Midwifery Womens Health. 2000 Jan-Feb;45(1):67-71. doi: 10.1016/s1526-9523(99)00019-7.
Levy R, Zaks S, Ben-Arie A, Perlman S, Hagay Z, Vaisbuch E. Can angle of progression in pregnant women before onset of labor predict mode of delivery? Ultrasound Obstet Gynecol. 2012 Sep;40(3):332-7. doi: 10.1002/uog.11195.
Other Identifiers
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0064-19-AAA
Identifier Type: -
Identifier Source: org_study_id
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