Biofeedback for Second Stage of Labor

NCT04210908 | Completed

• 1 other identifier: 0064-19-AAA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine whether transperineal ultrasound as visual biofeedback can be used during labor as an effective tool for shortening the second stage of labor and reducing the need for instrumental delivery, in a prospective randomized design.

Conditions

Labor Long; Labour;Obstructed

Keywords

Biofeedback; Second stage of labor; Operative delivery; Transperineal ultrasound

Outcome Measures

Primary Outcomes (1)

• Duration of the second stage of labor

  Minutes from first documentation of full dilatation to delivery.

  Up to 6 hours

Secondary Outcomes (6)

• Mode of delivery

  Up to 6 hours

• Neonatal 1 minute Apgar score

  Up to 6 hours

• Neonatal 5 minute Apgar score

  Up to 6 hours

• Cord pH

  Up to 6 hours

• Postpartum hemorrhage

  Up to 24 hours

Study Arms (2)

Biofeedback

EXPERIMENTAL

The patient will be instructed to bear down during 4 consecutive contractions while monitoring head descent using transperineal ultrasound. In the study group, patients will observe the descent of the head during contraction on the ultrasound display screen.

Other: Visual biofeedback

Control

NO INTERVENTION

The patient will be instructed to bear down during 4 consecutive contractions while monitoring head descent using transperineal ultrasound. In the control group, patients will not observe the ultrasound display screen.

Interventions

Visual biofeedback OTHER

Patient will observe the descent of the fetal head as they push during contractions

Biofeedback

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women in delivery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• First labor
• Full dilation
• Head position between SP-1 and SP+2.
• Epidural anesthesia
• No contraindication for vaginal delivery
• Parturient informed consent

You may not qualify if:

• Participation in parallel studies.
• Category III fetal monitoring requiring immediate delivery.

Sponsors & Collaborators

• Assuta Ashdod Hospital: lead

Study Sites (1)

Assuta Ashdod Hospital

Ashdod, Israel

Location

Related Publications (4)

• Kalache KD, Duckelmann AM, Michaelis SA, Lange J, Cichon G, Dudenhausen JW. Transperineal ultrasound imaging in prolonged second stage of labor with occipitoanterior presenting fetuses: how well does the 'angle of progression' predict the mode of delivery? Ultrasound Obstet Gynecol. 2009 Mar;33(3):326-30. doi: 10.1002/uog.6294.

  PMID: 19224527 BACKGROUND

• 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: 29155474 BACKGROUND

• Diegmann EK, Andrews CM, Niemczura CA. The length of the second stage of labor in uncomplicated, nulliparous African American and Puerto Rican women. J Midwifery Womens Health. 2000 Jan-Feb;45(1):67-71. doi: 10.1016/s1526-9523(99)00019-7.

  PMID: 10772737 BACKGROUND

• Levy R, Zaks S, Ben-Arie A, Perlman S, Hagay Z, Vaisbuch E. Can angle of progression in pregnant women before onset of labor predict mode of delivery? Ultrasound Obstet Gynecol. 2012 Sep;40(3):332-7. doi: 10.1002/uog.11195.

  PMID: 22605649 BACKGROUND

MeSH Terms

Conditions

Dystocia

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Eran Barzilay, MD PhD

  Samson Assuta Ashdod University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Obstetric and Gynecologic Ultrasound unit

Model Details: Open label randomized control trial

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 26, 2019
• Study Start: April 30, 2020
• Primary Completion: November 19, 2022
• Study Completion: November 25, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)