Biofeedback for Second Stage of Labor
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: Visual biofeedback
Patient will observe the descent of the fetal head as they push during contractions
|
| No Intervention: 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. |
Outcome Measures
Primary Outcome Measures
- Duration of the second stage of labor [Up to 6 hours]
Minutes from first documentation of full dilatation to delivery.
Secondary Outcome Measures
- Mode of delivery [Up to 6 hours]
Mode of delivery (categorical): spontaneous vaginal, operative vaginal or cesarean
- Neonatal 1 minute Apgar score [Up to 6 hours]
Apgar score at 1 minute after delivery (scale of 0-10)
- Neonatal 5 minute Apgar score [Up to 6 hours]
Apgar score at 5 minute after delivery (scale of 0-10)
- Cord pH [Up to 6 hours]
Umbilical cord blood pH
- Postpartum hemorrhage [Up to 24 hours]
Rate of early postpartum hemorrhage (during first 24 hours)
- Maternal perineal tears [Up to 6 hours]
Maternal perineal tear grade (categorical): None and grades 1-4
Eligibility Criteria
Criteria
Inclusion Criteria:
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First labor
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Full dilation
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Head position between SP-1 and SP+2.
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Epidural anesthesia
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No contraindication for vaginal delivery
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Parturient informed consent
Exclusion Criteria:
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Participation in parallel studies.
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Category III fetal monitoring requiring immediate delivery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Assuta Ashdod Hospital | Ashdod | Israel |
Sponsors and Collaborators
- Assuta Ashdod Hospital
Investigators
- Principal Investigator: Eran Barzilay, MD PhD, Samson Assuta Ashdod University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Kalache KD, Dückelmann 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.
- 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.
- 0064-19-AAA