Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

NCT ID: NCT06049784

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2026-12-31

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.

Detailed Description

The primary goal of this study is to evaluate the effectiveness of visual biofeedback prior to labor, which involves a single session in the hospital combined with a self-administered home ultrasound to train mothers on pushing techniques during the second stage of labor. The approach integrates a one-time pre-labor training session at the clinic, as previously explored by Youssef et al. (2021), with a continued two-week intervention carried out by the participants at home. This method is anticipated to enhance the benefits noted in prior research. The study will examine the impact of this training intervention and then collect comprehensive data on both obstetric and psychological outcomes, which will include medical records and self-report questionnaires completed by the participants before and after childbirth. The intervention seeks to mitigate maternal and neonatal obstetric complications and other adverse outcomes. The specific objectives of this study are:

1. to decrease the duration of the second stage of labor, minimize medical interventions during labor, and lessen birth-related complications;

2. to alleviate prenatal fear of childbirth and bolster confidence in the birthing process;

3. to enhance perceived personal control during labor and increase satisfaction with the birthing experience;

4. to improve maternal-infant bonding and reduce incidences of post-traumatic stress symptoms;

5. to explore participants' experiences with the at-home, self-managed intervention and its effectiveness through semi-structured, in-depth interviews with a subset of the participants involved in this study.

Conditions

Obstetric Labor Complications; Obstetric Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Visual Biofeedback using self operated home ultrasound device

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.

Group Type: EXPERIMENTAL

Visual Biofeedback using self operated home ultrasound device

Intervention Type: 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 at the Hospital

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.

Group Type: ACTIVE_COMPARATOR

Visual Biofeedback using ultrasound at hospital

Intervention Type: DEVICE

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

Control / Standard care - Obstetrical ultrasound only

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Visual Biofeedback using self operated home ultrasound 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.

Intervention Type: DEVICE

Visual Biofeedback using ultrasound at hospital

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tel Aviv University

OTHER

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sharon Perlman

Senior attending physician, Proffesor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharon Perlman, MD

Role: PRINCIPAL_INVESTIGATOR

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

Natav Hendin, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Rabin Medical Center

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Shira Waks

Role: CONTACT

Shiraw@clalit.org.il

972528557212

Sharon Perlman, MD

Role: CONTACT

drsharonperlman@gmail.com

972547481097

Facility Contacts

Sharon Perlman, Prof

Role: primary

drsharonperlman@gmail.com

972547481097

Natav Hendin, MD

Role: backup

Hendinatav@gmail.com

972546899506

References

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.

Reference Type: BACKGROUND

PMID: 29155474 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29532533 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33729014 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32105133 (View on PubMed)

Other Identifiers

RMC-0400-21

Identifier Type: -

Identifier Source: org_study_id