FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/095605 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 16/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   effect of antenatal exercise on health of pregnant women 
Scientific Title of Study   A Study to Assess the Effectiveness of Pelvic Stabilization Exercise on Biophysiological Parameters among Antenatal women in selected hospital of Central Gujarat 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ektaben Vikas Patel 
Designation  Assistant Professor 
Affiliation  Bhaikaka University 
Address  Room no. 205 Institute of Nursing Sciences, Bhaikaka University, Gokal Nagar, Karamsad, Anand, Gujarat

Anand
GUJARAT
388325
India 
Phone  8347433558  
Fax    
Email  ektapatel501@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Jayalakshmi Muthu Shrinivasan 
Designation  Research Supervisor 
Affiliation  PP Savani University 
Address  Room no. 101 PP Savani School of Nursing, PP Savani University, NH-8, GETCO, Near-Biltech, Village-Dhamdod, At & Po. Kosamba, Tal. Mangrol, Dist. Surat

Surat
GUJARAT
394125
India 
Phone  6380607969  
Fax    
Email  jayalakshmi.srinivasan@ppsu.ac.in  
 
Details of Contact Person
Public Query  
Name  Ektaben Vikas Patel 
Designation  Assistant Professor 
Affiliation  Bhaikaka University 
Address  Room no. 205 Institute of Nursing Sciences, Bhaikaka University, Gokal Nagar, Karamsad, Anand, Gujarat

Anand
GUJARAT
388325
India 
Phone  8347433558  
Fax    
Email  ektapatel501@gmail.com  
 
Source of Monetary or Material Support  
Infrastructure support from Shree Krishna Hospital, Bhaikaka University, Gokal Nagar, Karamsad, Anand, Gujarat- 388325 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [No any sponsor for the research study] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ektaben Vikas Patel  Shree Krishna Hospital, Karamsad  Obstetrics and Gyncecology dept. Shree Krishna Hospital, Anand - Sojitra Rd, Gokul Nagar, Karamsad, Anand, Gujarat 388325
Anand
GUJARAT 		 8347433558

ektapatel501@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaikaka University, Karamsad, Anand, Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Pelvic stabilization exercise for intervention group and for control group routine antenatal care will be provided  Intervention description The intervention group will receive a structured pelvic stabilization exercise program in addition to routine antenatal care. The exercise program is designed to strengthen the pelvic floor and core muscles, improve postural alignment, and reduce pelvic girdle pain. It will include: Warm-up and stretching for 5 minutes Core and pelvic floor activation exercises for 15–20 minutes Pelvic tilts, bridging, side lying leg raises, and stability ball exercises as tolerated Cool-down and relaxation for 5 minutes Frequency & duration Exercises will be administered under supervision 3 times per week for 6 weeks, with each session lasting approximately 30 minutes. Participants will also be encouraged to perform simple home-based exercises once daily. Control group Will receive only routine antenatal care without the specific pelvic stabilization exercise program. Duration of intervention will be 10 weeks. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women at 28-30 weeks of gestation.
2. Pregnant women in age years 21 to 35 years.
3. Pregnant women with or without mild anemia status.
4. Pregnant women with android/ios mobile phone self/family member.
5. Pregnant women with any number of parity. 
 
ExclusionCriteria 
Details  Pregnant women with associated any medical and surgical disorders.
2. Pregnant women with associated disorders of reproductive system.
3. Pregnant women with the past history of preterm labour pain, dyspnea prior to physical activity.
4. Pregnant women already taking any other treatment or therapy for pain relief.
5. Pregnant women with moderate or severe anemia status. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out the effect of pelvic stabilization exercise on biophysiological parameters in experimental group.  At baseline data collection, at 4th week, 8th week and at the time of delivery of patient. 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the effect of pelvic stabilization exercise on physical activity among experimental & control group.  At baseline data collection, at 4th week, 8th week & at the time of delivery of patient. 
To compare the effect of pelvic stabilization exercise on labour outcome & neonatal outcome among pregnant women of experimental & control group.  At baseline data collection, at 4th week, 8th week & at the time of delivery of patient. 
To find out the association of sociodemographic variable & biophysiological parameters among experimental & control group.  At baseline data collection, at 4th week, 8th week & at the time of delivery of patient. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The present study aims to assess the effectiveness of pelvic stabilization exercises on selected maternal and fetal outcomes among antenatal women with pelvic girdle pain in a hospital setting of Anand district, Gujarat. Pelvic girdle pain is a common musculoskeletal problem during pregnancy, often leading to reduced mobility, compromised physical activity, and adverse effects on maternal comfort and well-being. The study will evaluate the impact of a structured pelvic stabilization exercise program on biophysiological parameters (such as blood pressure, heart rate, and weight), intensity of pelvic girdle pain, level of physical activity, and feto-maternal outcomes. A randomized controlled design will be adopted, with antenatal women allocated to intervention and control groups. The intervention group will receive a pelvic stabilization exercise regimen in addition to routine antenatal care, while the control group will receive routine antenatal care only. Outcomes will be measured at baseline and at specified follow-up intervals using validated tools and obstetric records. It is anticipated that the findings will provide evidence for incorporating pelvic stabilization exercise as a safe and effective non-pharmacological intervention to improve maternal health, functional activity, and pregnancy outcomes. 
Close