NCT06857552

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2021

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

Same day

First QC Date

February 23, 2025

Last Update Submit

February 27, 2025

Conditions

Labor Stage, Second

Keywords

Prolonged second stageTransperineal ultrasoundbiofeedback

Outcome Measures

Primary Outcomes (2)

  • Length of the second stage of labor

    To investigate whether using of coached sonographic pushing will decrease the length of the second stage of labor.

    At baseline

  • Mode of delivery

    To investigate whether using of coached sonographic pushing will affect the rate of operative deliveries.

    At baseline

Secondary Outcomes (3)

  • Maternal outcomes

    At baseline

  • Neonatal Outcomes

    At baseline

  • Neonatal Outcomes

    At baseline

Study Arms (2)

Coached maternal pushing via ultrasound (US)

EXPERIMENTAL

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)

Traditional coached maternal pushing

NO INTERVENTION

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.

Interventions

Visual biofeedback using transperineal ultrasound (TPUS)OTHER

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

Coached maternal pushing via ultrasound (US)

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaplan Medical Center

Rehovot, Israel

Location

Related Publications (2)

  • 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.

    PMID: 29532533BACKGROUND

  • 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.

    PMID: 29155474BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Labor and Delivery

Study Record Dates

First Submitted

February 23, 2025

First Posted

March 4, 2025

Study Start

May 3, 2021

Primary Completion

May 3, 2021

Study Completion

September 7, 2024

Last Updated

March 4, 2025

Record last verified: 2025-02

Locations

IL(1)