Obstetric Labor Complications, Obstetric Trauma
Conditions
Keywords
Visual Biofeedback, Self Operated Ultrasound device, Second stage of labor, Trans Perineal Ultrasound
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 weeks of gestation and above): (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 approximately one week later and at six weeks postpartum. Positive results following the application of biofeedback by self-operated home ultrasound may change the paradigm for pre-labor 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 hospital session combined with a self-administered home ultrasound to train mothers in 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 intervention conducted by participants at home until delivery. This method is anticipated to enhance the benefits noted in prior research. The study will examine the impact of this training intervention and collect comprehensive data on obstetric and psychological outcomes, including medical records and self-report questionnaires completed by 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.
Interventions
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.
A single ultrasound biofeedback session using Transperineal Ultrasound will guide maternal pushing.
Sponsors
Study design
Masking description
The outcome assessor will collect the data from the files without knowing the participants' group assignment.
Intervention model description
Parallel assignment Randomised Control Trial
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The length of the second stage of labour | up to 1 week after labor | measure by time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| NICU (neonatal intensive care unit) hospitalization | up to 1 week after labor | number of participants who delivered a neonate transferred to the NICU |
| Fear of childbirth | up to 4 weeks before labor | Number of participants who demonstrated fear of childbirth according to questionnaires |
| PTSS (post traumatic stress symptoms) | up to 3 months post partum | Number of participants who demonstrated PTSS according to questionnaires |
Countries
Israel
Contacts
Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel
Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel