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Completed

NCT Number: NCT04210908

Biofeedback for Second Stage of Labor

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Ashdod Hospital

Ashdod, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Visual biofeedback

Other

Patient will observe the descent of the fetal head as they push during contractions

Primary outcomes

  1. Duration of the second stage of labor

    Time frame: Up to 6 hours

    Minutes from first documentation of full dilatation to delivery.

Secondary outcomes

  1. Mode of delivery

    Time frame: Up to 6 hours

    Mode of delivery (categorical): spontaneous vaginal, operative vaginal or cesarean

  2. Neonatal 1 minute Apgar score

    Time frame: Up to 6 hours

    Apgar score at 1 minute after delivery (scale of 0-10)

  3. Neonatal 5 minute Apgar score

    Time frame: Up to 6 hours

    Apgar score at 5 minute after delivery (scale of 0-10)

  4. Cord pH

    Time frame: Up to 6 hours

    Umbilical cord blood pH

  5. Postpartum hemorrhage

    Time frame: Up to 24 hours

    Rate of early postpartum hemorrhage (during first 24 hours)

  6. Maternal perineal tears

    Time frame: Up to 6 hours

    Maternal perineal tear grade (categorical): None and grades 1-4

Sponsors and collaborators

Lead sponsor

Assuta Ashdod Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 26, 2019
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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