Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

Not Applicable

Recruiting

• Conditions: Obstetric Trauma; Obstetric Labor Complications

• Registration Number: NCT06049784
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-17
• Study First Posted: 2023-09-22
• Study Start: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-06
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 261

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The length of the second stage of labour	up to 1 week after labor	measure by time

Secondary Outcome Measures

Name	Time	Method
Fear of childbirth	up to 4 weeks before labor	Number of participants who demonstrated fear of childbirth according to questionnaires
Mode of delivery	up to 1 week after labor	Number of participants with spontaneous vaginal delivery or operative delivery (operative assisted - vacuum assisted/forceps, cesarean delivery)
NICU (neonatal intensive care unit) hospitalization	up to 1 week after labor	number of participants who delivered a neonate transferred to the NICU
PTSS (post traumatic stress symptoms)	up to 3 months post partum	Number of participants who demonstrated PTSS according to questionnaires
OASIS - obstetrical anal sphincter injuries	up to 1 week after labor	Number of Participants with severe perineal tear
Low neonatal APGAR score	up to 1 week after labor	number of participants who delivered a neonate with APGAR score \< 7 at 5 minutes after birth

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel