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CTRI Number  CTRI/2025/07/091156 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Antenatal exercise in pregnancy on Labor and Birth Outcomes 
Scientific Title of Study   Effectiveness of Antenatal Exercise on Labor and Birth Outcomes in Uncomplicated Pregnancy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Razowana Tasnim 
Designation  MPT Student 
Affiliation  Jashore University of Science & Technology 
Address  Room No: 301, Department of Physiotherapy and Rehabilitation, Jashore University of Science & Technology, Jashore 7408, Bangladesh



7408
Other 
Phone  01794811092  
Fax    
Email  razowanatasnim2018@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Razowana Tasnim 
Designation  MPT Student 
Affiliation  Jashore University of Science & Technology 
Address  Room No: 301, Department of Physiotherapy and Rehabilitation, Jashore University of Science & Technology, Jashore 7408, Bangladesh



7408
Other 
Phone  01794811092  
Fax    
Email  razowanatasnim2018@gmail.com  
 
Details of Contact Person
Public Query  
Name  Md.Feroz Kabir 
Designation  Assistant Professor  
Affiliation  Jashore University of Science & Technology 
Address  Room No: 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science & Technology, Jashore 7408, Bangladesh



7408
Other 
Phone  01765932545  
Fax    
Email  feroz@just.edu.bd  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore 7408, Bangladesh 
Dhaka College of Physiotherapy,House 1039,Road-14/A,Adabor Main Rd, Dhaka 1207, Bangladesh 
 
Primary Sponsor  
Name  Dr. Ehsanur Rahman 
Address  Room No: 401,Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore 7408, Bangladesh 
Type of Sponsor  Other [University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raju Ahmed  BRB Hospitals Limited  Room No: 201, Physiotherapy Center, 77/A Panthapath, Dhaka 1215

 		 01718877376

rajuahmed.pt19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of the Department of Physiotherapy and Rehabilitation JUST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O631||Prolonged second stage (of labor),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Routine antenatal care  As per WHO and national guidelines 
Intervention  Structured antenatal exercise with routine antenatal care  • Aerobic Exercise • Strengthening Exercise • Stretching exercise • Pelvic floor exercise • Breathing and relaxation exercises Moderate intensity (Able to talk but not sing), 30-60 minutes each day At least 3-4 days per week, up to daily, as per patient tolerance and her own pace, from 28-30 weeks of pregnancy until labor 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Both primigravida and Multigravida
2. Being in the 28th–30th week of pregnancy
3. Uncomplicated pregnancy (defined by the absence of both pre-existing medical co-morbidities (e.g. type 2 diabetes, essential hypertension) and pre-existing/early obstetric (e.g. multiple pregnancy) or new-onset obstetric (e.g., gestational diabetes, pre-eclampsia) complications.
 
 
ExclusionCriteria 
Details  1. Women who are predetermined for cesarean section.
2. Unwilling to participate in antenatal exercise.
3. Individuals with contraindications to exercise according to ACOG guidelines
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Duration of labor
2. Mode of delivery 		 12 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Gestational age at delivery
2. Bishop score
3. APGAR score
4. Neonatal birthweight 		 12 weeks 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [razowanatasnim2018@gmail.com].

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 01-01-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

We will conduct a randomized clinical trial, consenting and randomizing 96 healthy pregnant women with singleton pregnancies between the 28th and 30th weeks and aged 18–35 years from a tertiary hospital. Women randomized to the intervention group will receive structured antenatal exercise supervised by a women’s health physiotherapist with routine antenatal care, while women randomized to the control group will receive routine antenatal care only. The primary outcome is mode of delivery and duration of labor, and the secondary outcomes will include gestational age at delivery, neonatal birthweight, Bishop score, and Apgar score. Analyses will be intention to treat with estimates reported as relative risks and 95% CIs.This will be included in the 1st paper in a series of two papers.  A secondary analysis will be considered after six months follow up related to post partum complications such as pelvic floor muscle function, dysperunia,Urinary incontinence, diastasis rectus abdominis in the second paper in a series of two papers.

 
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