The Effect of Ultrasound Guided Visual Biofeedback Performed by Midwifes on the Duration of the Active Second Stage of Labor

February 27, 2025 updated by: Roni Levy, Kaplan Medical Center

The Effect of Ultrasound Guided Visual Biofeedback Performed by Midwifes on the Duration of the Active Second Stage of Labor, a Randomized Controlled Trial

The goal of this randomized controlled trial is to investigate whether using of coached sonographic pushing will decrease the length of the second stage of labor and the rate of operative deliveries.

Researchers will compare women who undergo the traditional coached pushing to women who undergo visual biofeedback coached pushing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Rehovot, Israel
        • Kaplan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Singleton pregnancy
  • Nulliparous
  • 37-42 weeks of gestation
  • Under neuroaxial analgesia
  • Reached the second stage of labor
  • An estimated fetal weight between 2500-4000 grams

Exclusion Criteria:

  • Women who arrived in active labor and delivered before being assessed by a physician.
  • Women with contra-indications for vaginal birth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coached maternal pushing via ultrasound (US)

The study group, will have coached pushing using trans-perinal ultrasound (US) performed by the midwife during the active stage of labor, and after diagnosis of complete dilatation. Further, if not delivered within 2 hours of complete dilatation, a third coaching will be conducted. The coaching process in each will be performed for 10 minutes and for at least 3 contractions.

In the study group the women will observe the fetal head movements on the screen in front of her.
Other: Visual biofeedback using transperineal ultrasound (TPUS)
The intervention (study) arm will recieve coached maternal pushing via transperineal ultrasound (US) with visual biofeedback
No Intervention: Traditional coached maternal pushing
The control group will have the traditional coached pushing (vaginal) performed by a midwide during the active stage of labor, and after diagnosis of complete dilatation. Further, if not delivered within 2 hours of complete dilatation, a third coaching will be conducted. The coaching process in each will be performed for 10 minutes and for at least 3 contractions The women in the controlled group will have the vocal coaching of the midwife during the contractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of the second stage of labor
Time Frame: At baseline
To investigate whether using of coached sonographic pushing will decrease the length of the second stage of labor.
At baseline
Mode of delivery
Time Frame: At baseline
To investigate whether using of coached sonographic pushing will affect the rate of operative deliveries.
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal outcomes
Time Frame: At baseline
Maternal 3rd or 4th degree tear rate, postpartum hemorrhage rates
At baseline
Neonatal Outcomes
Time Frame: At baseline
Neonatal cord PH
At baseline
Neonatal Outcomes
Time Frame: At baseline
Apgar score less than 7 in 5 minutes.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaplan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Actual)

May 3, 2021

Study Completion (Actual)

September 7, 2024

Study Registration Dates

First Submitted

February 23, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0029-21-KMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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