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
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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COMPLETED
NA
324 participants
INTERVENTIONAL
2021-05-03
2024-09-07
Brief Summary
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Researchers will compare women who undergo the traditional coached pushing to women who undergo visual biofeedback coached pushing.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
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.
Visual biofeedback using transperineal ultrasound (TPUS)
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.
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
Eligibility Criteria
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Inclusion Criteria
* 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 with contra-indications for vaginal birth
FEMALE
Yes
Sponsors
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Kaplan Medical Center
OTHER
Responsible Party
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Roni Levy
Head of Labor and Delivery
Locations
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Kaplan Medical Center
Rehovot, , Israel
Countries
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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.
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.
Other Identifiers
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0029-21-KMC
Identifier Type: -
Identifier Source: org_study_id
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