Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

Obstetric Labor Complications Clinical Trial

Official title:

Prelabor Maternal Pushing Training Using Visual Biofeedback by a Self-operated Ultrasound Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049784
• Other study ID #: RMC-0400-21
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2023
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Rabin Medical Center
• Contact: Shira Waks
• Phone: 972528557212
• Email: Shiraw[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 261
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor Complications
• Obstetric Trauma

Intervention

Device:
• 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.
• Visual Biofeedback using ultrasound at hospital
A single ultrasound biofeedback session using Transperineal Ultrasound will guide maternal pushing.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The length of the second stage of labour	measure by time	up to 1 week after labor
Secondary	Mode of delivery	Number of participants with spontaneous vaginal delivery or operative delivery (operative assisted - vacuum assisted/forceps, cesarean delivery)	up to 1 week after labor
Secondary	OASIS - obstetrical anal sphincter injuries	Number of Participants with severe perineal tear	up to 1 week after labor
Secondary	Low neonatal APGAR score	number of participants who delivered a neonate with APGAR score < 7 at 5 minutes after birth	up to 1 week after labor
Secondary	NICU (neonatal intensive care unit) hospitalization	number of participants who delivered a neonate transferred to the NICU	up to 1 week after labor
Secondary	Fear of childbirth	Number of participants who demonstrated fear of childbirth according to questionnaires	up to 4 weeks before labor
Secondary	PTSS (post traumatic stress symptoms)	Number of participants who demonstrated PTSS according to questionnaires	up to 3 months post partum