Biofeedback for Second Stage of Labor

Not Applicable

Completed

• Conditions: Labor Long; Labour;Obstructed
• Interventions: Other: Visual biofeedback

• Registration Number: NCT04210908
• Lead Sponsor: Assuta Ashdod Hospital

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.

Study Timeline

• Study First Submitted: 2019-12-15
• Study First Submitted QC: 2019-12-22
• Study First Posted: 2019-12-26
• Study Start: 2020-04-30
• Status Verified: 2022-11
• Primary Completion: 2022-11-19
• Study Completion: 2022-11-25
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. First labor
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

1. Participation in parallel studies.
2. Category III fetal monitoring requiring immediate delivery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback	Visual 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.

Primary Outcome Measures

Name	Time	Method
Duration of the second stage of labor	Up to 6 hours	Minutes from first documentation of full dilatation to delivery.

Secondary Outcome Measures

Name	Time	Method
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)
Cord pH	Up to 6 hours	Umbilical cord blood pH
Neonatal 5 minute Apgar score	Up to 6 hours	Apgar score at 5 minute after delivery (scale of 0-10)
Maternal perineal tears	Up to 6 hours	Maternal perineal tear grade (categorical): None and grades 1-4
Postpartum hemorrhage	Up to 24 hours	Rate of early postpartum hemorrhage (during first 24 hours)

Trial Locations

Locations (1)

Assuta Ashdod Hospital; 🇮🇱 Ashdod, Israel