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

NCT ID: NCT06857552

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2024-09-07

Brief Summary

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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.

Detailed Description

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Conditions

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Labor Stage, Second

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Visual biofeedback using transperineal ultrasound (TPUS)

Intervention Type OTHER

The intervention (study) arm will recieve coached maternal pushing via transperineal ultrasound (US) with visual biofeedback

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Visual biofeedback using transperineal ultrasound (TPUS)

The intervention (study) arm will recieve coached maternal pushing via transperineal ultrasound (US) with visual biofeedback

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kaplan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Roni Levy

Head of Labor and Delivery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kaplan Medical Center

Rehovot, , Israel

Site Status

Countries

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Israel

References

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Bellussi F, Alcamisi L, Guizzardi G, Parma D, Pilu G. Traditionally vs sonographically coached pushing in second stage of labor: a pilot randomized controlled trial. Ultrasound Obstet Gynecol. 2018 Jul;52(1):87-90. doi: 10.1002/uog.19044. Epub 2018 May 30.

Reference Type BACKGROUND
PMID: 29532533 (View on PubMed)

Gilboa Y, Frenkel TI, Schlesinger Y, Rousseau S, Hamiel D, Achiron R, Perlman S. Visual biofeedback using transperineal ultrasound in second stage of labor. Ultrasound Obstet Gynecol. 2018 Jul;52(1):91-96. doi: 10.1002/uog.18962. Epub 2018 May 29.

Reference Type BACKGROUND
PMID: 29155474 (View on PubMed)

Other Identifiers

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0029-21-KMC

Identifier Type: -

Identifier Source: org_study_id

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