Prelabor Maternal Pushing Training Using Visual Biofeedback by a Self-operated Ultrasound Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- The length of the second stage of labour
研究概览
简要总结
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.
详细描述
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:
- to decrease the duration of the second stage of labor, minimize medical interventions during labor, and lessen birth-related complications;
- to alleviate prenatal fear of childbirth and bolster confidence in the birthing process;
- to enhance perceived personal control during labor and increase satisfaction with the birthing experience;
- to improve maternal-infant bonding and reduce incidences of post-traumatic stress symptoms;
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Outcomes Assessor)
盲法说明
The outcome assessor will collect the data from the files without knowing the participants' group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nuliparity
- •Singleton pregnancy
- •Planned for vaginal delivery
- •Low risk pregnancy
- •Ability to fulfill a questionnaire
排除标准
- •Multifetal gestation
- •Contraindications for vaginal delivery (Placenta previa, Breech presentation etc.)
- •High risk pregnancy
研究组 & 干预措施
Visual Biofeedback using self operated home ultrasound device
Sonographic fetal weight and biophysical profiles will be done at the hospital clinic. A single ultrasound biofeedback session using transperineal 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 and will learn to perform self-biofeedback at home, ideally twice a week until delivery. Session records will be sent electronically to the sonographer for assessment and feedback.
All groups will complete questionnaires three times: (1) baseline, (2) approximately one week later (after home biofeedback training), and (3) six weeks postpartum.
干预措施: Visual Biofeedback using self operated home ultrasound device (Device)
Visual biofeedback at the Hospital
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.
干预措施: Visual Biofeedback using ultrasound at hospital (Device)
Control / Standard care - Obstetrical ultrasound only
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.
结局指标
主要结局
The length of the second stage of labour
时间窗: up to 1 week after labor
measure by time
次要结局
- Fear of childbirth(up to 4 weeks before labor)
- Mode of delivery(up to 1 week after labor)
- NICU (neonatal intensive care unit) hospitalization(up to 1 week after labor)
- PTSS (post traumatic stress symptoms)(up to 3 months post partum)
- OASIS - obstetrical anal sphincter injuries(up to 1 week after labor)
- Low neonatal APGAR score(up to 1 week after labor)
研究者
Sharon Perlman
Senior attending physician, Proffesor of Obstetrics and Gynecology
Rabin Medical Center