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Completed

NCT Number: NCT06857552

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

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.

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Key information

Conditions

Labor Stage, Second Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaplan Medical Center

Rehovot, Israel

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Visual biofeedback using transperineal ultrasound (TPUS)

Other

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

Primary outcomes

  1. 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.

  2. Mode of delivery

    Time frame: At baseline

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

Secondary outcomes

  1. Maternal outcomes

    Time frame: At baseline

    Maternal 3rd or 4th degree tear rate, postpartum hemorrhage rates

  2. Neonatal Outcomes

    Time frame: At baseline

    Neonatal cord PH

  3. Neonatal Outcomes

    Time frame: At baseline

    Apgar score less than 7 in 5 minutes.

Sponsors and collaborators

Lead sponsor

Kaplan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2024
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

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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