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Clinical Trials/NCT04210908
NCT04210908
Completed
Not Applicable

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

Assuta Ashdod Hospital1 site in 1 country100 target enrollmentApril 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Labor Long
Sponsor
Assuta Ashdod Hospital
Enrollment
100
Locations
1
Primary Endpoint
Duration of the second stage of labor
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 30, 2020
End Date
November 25, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Assuta Ashdod Hospital
Responsible Party
Principal Investigator
Principal Investigator

Eran Brazilay, MD PhD

Head of the Obstetric and Gynecologic Ultrasound unit

Assuta Ashdod Hospital

Eligibility Criteria

Inclusion Criteria

  • First labor
  • Full dilation
  • Head position between SP-1 and SP+
  • Epidural anesthesia
  • No contraindication for vaginal delivery
  • Parturient informed consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

Duration of the second stage of labor

Time Frame: Up to 6 hours

Minutes from first documentation of full dilatation to delivery.

Secondary Outcomes

  • Mode of delivery(Up to 6 hours)
  • Neonatal 1 minute Apgar score(Up to 6 hours)
  • Cord pH(Up to 6 hours)
  • Neonatal 5 minute Apgar score(Up to 6 hours)
  • Maternal perineal tears(Up to 6 hours)
  • Postpartum hemorrhage(Up to 24 hours)

Study Sites (1)

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