Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

Study Overview
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Brief Summary
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A substantial number of women report fear of childbirth and negative birth experiences. Our objective is to assess the efficacy of visual biofeedback before labor by 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. Visual biofeedback has been performed only in an in-hospital setting and, with one exception we are aware of, only during labor. A Mobile Self-Operated Home Ultrasound System was 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; (1) 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
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The main objective of the present study is to assess the efficacy of visual biofeedback before labor by combining a single in-hospital session with a self-operated home ultrasound to train maternal pushing during the second stage of labor. The study combines the advantage of pre-labor training women in a single session at the clinic, as studied previously (Youssef et al., 2021), with an extended intervention and self-performed procedure at home over two weeks. This intervention is expected to augment the advantages previously described in the literature. The proposed study will assess the advantages of this intervention during training, followed by collecting detailed information on obstetric and psychological outcomes from medical records and using self-report questionnaires filled in by the participants before birth and postpartum. This intervention aims to prevent maternal and neonatal obstetric complications and adverse outcomes. Specifically, we aim: to shorten the length of the second stage, reduce the number of medical interventions during labor, and reduce complications during birth; to reduce prenatal fear of childbirth and increase confidence in the ability to give birth; to increase perceived personal control during labor and birth satisfaction; to improve maternal-infant bonding and reduce the rate of post-traumatic stress symptoms. to understand women's experience of the self-operated at-home intervention and its contribution through semi-structured in-depth interviews with a subsample of the women who participated in this study condition.

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

Conditions
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Obstetric Labor Complications, Obstetric Trauma

Intervention / Treatment
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* Device: Visual Biofeedback using self operated home ultrasound device
* Device: Visual Biofeedback using ultrasound at hospital


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Study design: A randomized controlled trial will be conducted at a single medical center. Intervention: Visual biofeedback by ultrasound will be performed by transperineal Ultrasound (TPU), enabling the future mother to visualize the descent of the fetal head within the birth canal in response to her pushing effort. Arms: (1) Home and hospital Intervention - Obstetrical ultrasound + visual biofeedback at the clinic and home using self-operated TPU. (2) Hospital intervention - Obstetrical ultrasound + visual biofeedback at the clinic (only one session in hospital). (3) Control / Standard care - Obstetrical ultrasound only. Arms 1 and 2, compared to 3, will support the efficacy of pre-labor training with visual biofeedback. Arm 1 versus 2 will support the added value of supplementing the in-hospital training with several additional sessions at home.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visual Biofeedback using self operated home ultrasound device<br>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<br>* 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.<br>|
| Active Comparator: Visual biofeedback at the Hospital<br>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<br>* A single ultrasound biofeedback session using Transperineal Ultrasound will guide maternal pushing.<br>|
| No Intervention: Control / Standard care - Obstetrical ultrasound only<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of the second stage of labour | Length of second stage of labor in minutes according to data retrieved from computerised medical file | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery | Spontaneous vaginal delivery or assisted operative delivery according to data retrieved from computerised medical file | through study completion, an average of 6 months | 
| OASIS - obstetrical anal sphincter injuries | according to data retrieved from computerised medical file | through study completion, an average of 6 months | 
| Low neonatal APGAR score | according to data retrieved from computerised medical file | through study completion, an average of 6 months | 
| NICU (neonatal intensive care unit) hospitalization | according to data retrieved from computerised medical file | through study completion, an average of 6 months | 
| Fear of childbirth | according to questionaires | through study completion, an average of 6 months | 
| Anticipated self-control over various aspects of childbirth | according to questionaires | through study completion, an average of 6 months | 
| PTSS (post traumatic tree symptoms) | according to questionaires | through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual Biofeedback, Self Operated Ultrasound device, Second stage of labor, Trans Perineal Ultrasound