Biofeedback for Second Stage of Labor
Primary Purpose
Labor Long, Labour;Obstructed
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Visual biofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Labor Long focused on measuring Biofeedback, Second stage of labor, Operative delivery, Transperineal ultrasound
Eligibility Criteria
Inclusion Criteria:
- First labor
- Full dilation
- Head position between SP-1 and SP+2.
- Epidural anesthesia
- No contraindication for vaginal delivery
- Parturient informed consent
Exclusion Criteria:
- Participation in parallel studies.
- Category III fetal monitoring requiring immediate delivery.
Sites / Locations
- Assuta Ashdod Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Biofeedback
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Duration of the second stage of labor
Minutes from first documentation of full dilatation to delivery.
Secondary Outcome Measures
Mode of delivery
Mode of delivery (categorical): spontaneous vaginal, operative vaginal or cesarean
Neonatal 1 minute Apgar score
Apgar score at 1 minute after delivery (scale of 0-10)
Neonatal 5 minute Apgar score
Apgar score at 5 minute after delivery (scale of 0-10)
Cord pH
Umbilical cord blood pH
Postpartum hemorrhage
Rate of early postpartum hemorrhage (during first 24 hours)
Maternal perineal tears
Maternal perineal tear grade (categorical): None and grades 1-4
Full Information
NCT ID
NCT04210908
First Posted
December 15, 2019
Last Updated
November 28, 2022
Sponsor
Assuta Ashdod Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04210908
Brief Title
Biofeedback for Second Stage of Labor
Official Title
Ultrasound Imaging Biofeedback for Shortening the Second Stage of Labor: a Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
November 19, 2022 (Actual)
Study Completion Date
November 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assuta Ashdod Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Long, Labour;Obstructed
Keywords
Biofeedback, Second stage of labor, Operative delivery, Transperineal ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open label randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Visual biofeedback
Intervention Description
Patient will observe the descent of the fetal head as they push during contractions
Primary Outcome Measure Information:
Title
Duration of the second stage of labor
Description
Minutes from first documentation of full dilatation to delivery.
Time Frame
Up to 6 hours
Secondary Outcome Measure Information:
Title
Mode of delivery
Description
Mode of delivery (categorical): spontaneous vaginal, operative vaginal or cesarean
Time Frame
Up to 6 hours
Title
Neonatal 1 minute Apgar score
Description
Apgar score at 1 minute after delivery (scale of 0-10)
Time Frame
Up to 6 hours
Title
Neonatal 5 minute Apgar score
Description
Apgar score at 5 minute after delivery (scale of 0-10)
Time Frame
Up to 6 hours
Title
Cord pH
Description
Umbilical cord blood pH
Time Frame
Up to 6 hours
Title
Postpartum hemorrhage
Description
Rate of early postpartum hemorrhage (during first 24 hours)
Time Frame
Up to 24 hours
Title
Maternal perineal tears
Description
Maternal perineal tear grade (categorical): None and grades 1-4
Time Frame
Up to 6 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women in delivery
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
First labor
Full dilation
Head position between SP-1 and SP+2.
Epidural anesthesia
No contraindication for vaginal delivery
Parturient informed consent
Exclusion Criteria:
Participation in parallel studies.
Category III fetal monitoring requiring immediate delivery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eran Barzilay, MD PhD
Organizational Affiliation
Samson Assuta Ashdod University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuta Ashdod Hospital
City
Ashdod
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19224527
Citation
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.
Results Reference
background
PubMed Identifier
29155474
Citation
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.
Results Reference
background
PubMed Identifier
10772737
Citation
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.
Results Reference
background
PubMed Identifier
22605649
Citation
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.
Results Reference
background
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Biofeedback for Second Stage of Labor
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