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临床试验/CTRI/2025/08/093708
CTRI/2025/08/093708尚未招募不适用

Effect of birthing ball exercises versus conventional physiotherapy on maternal and neonatal outcomes in healthy antenatal mothers A Randomized Control Trial

Dr Ketki Kunjarkar2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
2
主要终点
Total Duration of Labor,Type of Delivery, Apgar Scores measured at 5 minutes after birth

研究概览

简要总结

The rising prevalence of labor complications and cesarean deliveries calls for simple, safe, and cost effective interventions to support natural childbirth. Birthing ball exercises have shown potential in reducing pain, shortening the duration of labor, and enhancing maternal satisfaction, yet their use in routine antenatal care remains limited. This study aims to compare the effectiveness of birthing ball exercises with conventional physiotherapy in improving maternal and neonatal outcomes among antenatal women. The objectives are to evaluate maternal outcomes such as duration of labor, type of delivery, intensity of labor pain, and perception of childbirth along with neonatal outcomes including Apgar score at five minutes and the rate of NICU admissions. The research question focuses on whether birthing ball exercises are more effective than conventional physiotherapy. The null hypothesis states that no significant difference exists between the two groups while the alternative hypothesis proposes a significant difference in outcomes.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women aged over
  • 35 years, nulliparous, in their third trimester (more than or equal to 28 weeks of gestation), with a singleton pregnancy, and cephalic presentation No major obstetric complications and normal extremities allowing the performance of activities Willing to participate in the study and provide written informed consent.

排除标准

  • High-risk pregnancies (e.g., preeclampsia, gestational diabetes, placenta previa).
  • Known fetal anomalies or complications.
  • Previous uterine surgery or history of cesarean delivery.
  • Medical conditions limiting participation in physiotherapy (e.g., musculoskeletal disorders, cardiovascular issues).

结局指标

主要结局

Total Duration of Labor,Type of Delivery, Apgar Scores measured at 5 minutes after birth

时间窗: Total Duration of Labor – At delivery (Day 0) | Type of Delivery – At delivery (Day 0) | Apgar Score – At 5 minutes after birth (Day 0)

次要结局

  • Labor Pain Intensity (Visual Analog Scale - VAS)(Perception of Childbirth (MPCS - Maternal Perception of Childbirth Scale))

研究者

发起方
Dr Ketki Kunjarkar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ketki Kunjarkar

Pravara Institute of Medical Sciences

研究点 (2)

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