Biofeedback for Second Stage of Labor

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ultrasound Imaging Biofeedback for Shortening the Second Stage of Labor: a Randomized Prospective Study

Conditions
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Labor Long, Labour;Obstructed

Intervention / Treatment
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* Other: Visual biofeedback


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofeedback<br>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<br>* Patient will observe the descent of the fetal head as they push during contractions<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the second stage of labor | Minutes from first documentation of full dilatation to delivery. | Up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery | Mode of delivery (categorical): spontaneous vaginal, operative vaginal or cesarean | Up to 6 hours | 
| Neonatal 1 minute Apgar score | Apgar score at 1 minute after delivery (scale of 0-10) | Up to 6 hours | 
| Neonatal 5 minute Apgar score | Apgar score at 5 minute after delivery (scale of 0-10) | Up to 6 hours | 
| Cord pH | Umbilical cord blood pH | Up to 6 hours | 
| Postpartum hemorrhage | Rate of early postpartum hemorrhage (during first 24 hours) | Up to 24 hours | 
| Maternal perineal tears | Maternal perineal tear grade (categorical): None and grades 1-4 | Up to 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biofeedback, Second stage of labor, Operative delivery, Transperineal ultrasound