Department of Obstetrics and Gynecological Nursing, Manipal College of Nursing, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, 576104, India.
Sikkim Manipal Institute of Medical Sciences(SMIMS),, Sikkim Manipal University(SMU),, Gangtok, Sikkim, India.
F1000Res. 2022 Jun 29;11:717. doi: 10.12688/f1000research.109537.2. eCollection 2022.
Frequent positional changes and movements during labour is one of the recommendations by the World Health Organization (WHO) to prevent prolonged labour, thereby avoiding cesarean sections. However, labour induction, continuous fetal monitoring in supine position and immobilising the women during labour are standard practices in most private hospitals. To combat these problems and to implement WHO recommendations, the peanut ball is an effective device through which frequent positional changes will be achieved without disrupting the labour procedures. The current study aims to evaluate the effectiveness of the peanut ball device during labour on maternal and neonatal outcomes and assess the stress response induced by labour in terms of maternal and neonatal cortisol in low-risk primigravid women. The study is a prospective, block randomised controlled trial with parallel arms. A total of 768 study participants will be randomised to the peanut-ball group (intervention) and standard care group (control). The intervention group will receive different peanut ball positions during labour at or after 4 cm of cervical dilatation. The primary outcomes of the study are maternal outcome that includes measurement of duration of the active and the second stage of labour, stress level as measured by serum cortisol level at 3-4 cm and at 10 cm of cervical dilatation, mode of delivery, perception of pain, behavioural response during the active stage of labour and neonatal outcomes, which includes the pattern of fetal heart rate, APGAR score, birth injuries, and umbilical serum and salivary cortisol level. The collected data will be compared between the intervention and control groups. This research is registered under the CTRI (Clinical Trials Registry of India) ( CTRI/2019/08/020802) (21/8/2019).
产妇在分娩过程中频繁改变姿势和运动是世界卫生组织（WHO）预防产程延长、避免剖宫产的建议之一。然而，在大多数私立医院，引产、产妇仰卧位持续胎儿监护和分娩时固定产妇是标准做法。为了解决这些问题并实施世界卫生组织的建议，花生球是一种有效的装置，可以在不干扰分娩过程的情况下实现频繁的姿势改变。本研究旨在评估分娩过程中使用花生球装置对母婴结局的影响，并评估低危初产妇分娩时的皮质醇应激反应。本研究是一项前瞻性、随机分组、平行对照试验。共有 768 名研究参与者将被随机分配到花生球组（干预组）和标准护理组（对照组）。干预组将在宫颈扩张 4cm 或之后的产程中接受不同的花生球姿势。研究的主要结局是母婴结局，包括活跃期和第二产程的持续时间、血清皮质醇水平在 3-4cm 和 10cm 宫颈扩张时的应激水平、分娩方式、疼痛感知、活跃期的行为反应以及新生儿结局，包括胎儿心率模式、APGAR 评分、出生损伤以及脐血清和唾液皮质醇水平。将比较干预组和对照组之间的收集数据。本研究在 CTRI（印度临床试验注册中心）（CTRI/2019/08/020802）（2019 年 8 月 21 日）注册。
