Clinical trial NCT06049784: Prelabor Visual Biofeedback by a Self-operated Ultrasound Device
Official title: Prelabor Maternal Pushing Training Using Visual Biofeedback by a Self-operated Ultrasound Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstetric Labor Complications
Obstetric Trauma
Keywords: Visual Biofeedback
Self Operated Ultrasound device
Second stage of labor
Trans Perineal Ultrasound
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2023-09-22
Enrollment: 261
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment Randomised Control Trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The length of the second stage of labour
timeFrame: up to 1 week after labor
Secondary outcomes:
measure: Mode of delivery
timeFrame: up to 1 week after labor
measure: OASIS - obstetrical anal sphincter injuries
timeFrame: up to 1 week after labor
measure: Low neonatal APGAR score
timeFrame: up to 1 week after labor
measure: NICU (neonatal intensive care unit) hospitalization
timeFrame: up to 1 week after labor
measure: Fear of childbirth
timeFrame: up to 4 weeks before labor
measure: PTSS (post traumatic stress symptoms)
timeFrame: up to 3 months post partum
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel
name: Sharon Perlman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel
name: Natav Hendin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.