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Clinical Trials/CTRI/2025/08/093708
CTRI/2025/08/093708Not yet recruitingNot Applicable

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

Dr Ketki Kunjarkar2 sites in 1 country70 target enrollmentStarted: September 15, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
70
Locations
2
Primary Endpoint
Total Duration of Labor,Type of Delivery, Apgar Scores measured at 5 minutes after birth

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 35.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

Investigators

Sponsor
Dr Ketki Kunjarkar
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Ketki Kunjarkar

Pravara Institute of Medical Sciences

Study Sites (2)

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