Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

NCT06049784 | Recruiting

• 1 other identifier: RMC-0400-21
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

Brief Summary

A substantial number of women report fear of childbirth and negative birth experiences. The objective of the study is to assess the efficacy of visual biofeedback before labor using a self-operated home ultrasound for maternal pushing training, which is expected to reduce fear of childbirth, increase perceived control during birth, prevent prolonged labor and the ensuing maternal and neonatal negative adverse outcomes, and prevent maternal post-traumatic stress symptoms. Intrapartum visual biofeedback provided by obstetricians during the second stage of labor has been shown to increase pushing efficiency and improve maternal obstetric and psychological outcomes. Previously, visual biofeedback has been implemented only in an in-hospital setting and, with one known exception, only during labor. A Mobile Self-Operated Home Ultrasound System has been reported as a feasible and reliable tool for obstetrical ultrasound. A randomized controlled trial will be conducted with three study groups of pregnant women (37-39 weeks of gestation): (1) Obstetrical ultrasound+visual biofeedback in-hospital and at home using self-operated ultrasound; (2) Obstetrical ultrasound+visual biofeedback in-hospital; (3) Obstetrical ultrasound only. Visual biofeedback by ultrasound will be performed by transperineal ultrasound, enabling the future mother to visualize the descent of the fetal head within the birth canal in response to her pushing effort. Follow-up will be conducted two weeks later and at six weeks postpartum. Positive results following the application of biofeedback by self-operated home ultrasound may change the paradigm for pre-labour sonographic education. Self-operated home ultrasound will also enable more comprehensive pre-labor ultrasound-based education and hopefully reduce adverse physical and psychological outcomes following childbirth.

Conditions

Obstetric Labor Complications; Obstetric Trauma

Keywords

Visual Biofeedback; Self Operated Ultrasound device; Second stage of labor; Trans Perineal Ultrasound

Outcome Measures

Primary Outcomes (1)

• The length of the second stage of labour

  measure by time

  up to 1 week after labor

Secondary Outcomes (6)

• Mode of delivery

  up to 1 week after labor

• OASIS - obstetrical anal sphincter injuries

  up to 1 week after labor

• Low neonatal APGAR score

  up to 1 week after labor

• NICU (neonatal intensive care unit) hospitalization

  up to 1 week after labor

• Fear of childbirth

  up to 4 weeks before labor

Study Arms (3)

Visual Biofeedback using self operated home ultrasound device

EXPERIMENTAL

Sonographic fetal weight and biophysical profiles will be done at the hospital clinic. A single ultrasound biofeedback session using trans-perineal Ultrasound (TPU) will guide maternal pushing. The process includes (a) Ultrasound assessing fetal head descent with the screen facing the provider, measuring the angle of progression (AOP); (b) Explaining anatomical landmarks to the patient; (c) Repeat AOP measurement with the screen facing the patient for biofeedback; (d) Reassess with the screen turned away. Participants will receive a handheld home ultrasound device, learning to perform self-biofeedback at home, ideally twice a week, up to 4 times. Session records will be sent electronically to the sonographer for assessment and feedback. All groups will complete questionnaires three times: (1) baseline, (2) about two weeks later (after home biofeedback training), and (3) six to eight weeks postpartum.

Device: Visual Biofeedback using self operated home ultrasound device

Visual biofeedback at the Hospital

ACTIVE COMPARATOR

A sonographic fetal weight estimate and biophysical profile will occur at the hospital clinic for all patients. A single ultrasound-based biofeedback session will employ TPU for maternal pushing guidance. This process involves (a) Assessing fetal head descent with ultrasound to measure the angle of progression (AOP) during rest and pushing; (b) Explaining anatomical landmarks to the patient; (c) Repeating the AOP measurement as biofeedback; (d) Reassessing with the screen turned away. Participants will complete questionnaires three times: (1) baseline, (2) two weeks later, and (3) six to eight weeks postpartum.

Device: Visual Biofeedback using ultrasound at hospital

Control / Standard care - Obstetrical ultrasound only

NO INTERVENTION

A sonographic estimated fetal weight and biophysical profile will be performed in the hospital. The participant will fill in questionnaires at three time points: (1) at baseline, before the ultrasound examination; (2) about two weeks later (i.e., after completing the self-operated visual biofeedback training at home, or at an equivalent time for the other two groups); (3) six to eight weeks postpartum.

Interventions

Visual Biofeedback using self operated home ultrasound device DEVICE

participants will receive a handheld home ultrasound device, learning to perform self-biofeedback at home. Session records will be sent electronically to the sonographer for assessment and feedback.

Visual Biofeedback using self operated home ultrasound device

Visual Biofeedback using ultrasound at hospital DEVICE

A single ultrasound biofeedback session using Transperineal Ultrasound will guide maternal pushing.

Visual biofeedback at the Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nuliparity
• Singleton pregnancy
• Planned for vaginal delivery
• Low risk pregnancy
• Ability to fulfill a questionnaire

You may not qualify if:

• Multifetal gestation
• Contraindications for vaginal delivery (Placenta previa, Breech presentation etc.)
• High risk pregnancy

Sponsors & Collaborators

• Rabin Medical Center: lead
• Tel Aviv University: collaborator

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

Related Publications (4)

• 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

• 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: 29532533 BACKGROUND

• Hadar E, Wolff L, Tenenbaum-Gavish K, Eisner M, Shmueli A, Barbash-Hazan S, Bergel R, Shmuel E, Houri O, Dollinger S, Brzezinski-Sinai NA, Sukenik S, Pardo A, Navon I, Wilk Y, Zafrir-Danieli H, Wiznitzer A. Mobile Self-Operated Home Ultrasound System for Remote Fetal Assessment During Pregnancy. Telemed J E Health. 2022 Jan;28(1):93-101. doi: 10.1089/tmj.2020.0541. Epub 2021 Mar 15.

  PMID: 33729014 BACKGROUND

• Schlesinger Y, Hamiel D, Rousseau S, Perlman S, Gilboa Y, Achiron R, Frenkel TI. Preventing risk for posttraumatic stress following childbirth: Visual biofeedback during childbirth increases maternal connectedness to her newborn thereby preventing risk for posttraumatic stress following childbirth. Psychol Trauma. 2022 Sep;14(6):1057-1065. doi: 10.1037/tra0000558. Epub 2020 Feb 27.

  PMID: 32105133 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sharon Perlman, MD

  Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel

  PRINCIPAL INVESTIGATOR

• Natav Hendin, MD

  Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shira Waks

CONTACT

972528557212; Shiraw@clalit.org.il

Sharon Perlman, MD

CONTACT

972547481097; drsharonperlman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will collect the data from the files without knowing the participants' group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior attending physician, Proffesor of Obstetrics and Gynecology

Model Details: Parallel assignment Randomised Control Trial

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 22, 2023
• Study Start: December 31, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)