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CTRI Number  CTRI/2021/03/032422 [Registered on: 30/03/2021] Trial Registered Prospectively
Last Modified On: 22/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   The effect of pelvic floor muscles on the mode of delivery like normal vaginal delivery or caesarean section.  
Scientific Title of Study   Impact of pelvic floor muscle strength on mode of delivery  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  poornaveni mohan  
Designation  junior resident  
Affiliation  kasturba medical college , manipal  
Address  department of OBG , kasturba medical college , manipal
kasturba medical college , manipal-576104
Udupi
KARNATAKA
576104
India 
Phone  8754762880  
Fax    
Email  shloka17.naidu.pm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrDeeksha Pandey  
Designation  Associate professor  
Affiliation  kasturba medical college , manipal  
Address  department of OBG , kasturba medical college , manipal
kasturba medical college , manipal-576104
Udupi
KARNATAKA
576104
India 
Phone  09241216016  
Fax    
Email  deekshiiiobg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  poornaveni mohan  
Designation  junior resident  
Affiliation  kasturba medical college , manipal  
Address  department of OBG , kasturba medical college , manipal
kasturba medical college , manipal-576104
Udupi
KARNATAKA
576104
India 
Phone  8754762880  
Fax    
Email  shloka17.naidu.pm@gmail.com  
 
Source of Monetary or Material Support  
Kasturba medical college , manipal  
 
Primary Sponsor  
Name  dr poornaveni mohan  
Address  department of OBG, KMC, manipal  
Type of Sponsor  Research institution and hospital 
 
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 
poornaveni mohan   kasturba hospital , manipal   Antenatal scan room , 3rd floor , department of OBG Women and children block
Udupi
KARNATAKA 
8754762880

shloka17.naidu.pm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kasturba medical college and kasturba hospital institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  39.00 Year(s)
Gender  Female 
Details  primigravida
singleton pregnancy
term (37+ weeks to 40 weeks)
cephalic presentation  
 
ExclusionCriteria 
Details  abnormal presentations
multiple gestations
cephalopelvic disproportions (CPD) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.mode of delivery
2.duration of first stage and second stage of labor 
before delivery  
 
Secondary Outcome  
Outcome  TimePoints 
Need for instrumentation
Need for Fundal Pressure
Episiotomy extensions/perineal tears
 
during delivery  
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
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)   01/04/2021 
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="2"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The pelvic floor muscles have an essential role in continence and provide support to the pelvic organs. They also have an impact on labour. The pelvic floor muscles should distend to allow the passage of the foetus during labour. The rotation and flexion of the foetal head is due to the pelvic floor resistance. The effect of a vaginal birth on the pelvic floor’s function is readily understood. On the other hand, the effect of the pelvic floor muscle function on labour is still controversial.There are previous prospective studies , that have shown that there is a negative association between the pelvic floor muscle strength and preterm labour. Pelvic floor physical therapy may be an alternative preventive strategy to reduce the risk of a spontaneous preterm birth. Biomechanics of pelvic floor muscles is becoming an important field of research in understanding a complex process of labour. Current evidence indicates that the levator ani stretches to allow passage of the fetus through the birth canal. We sought to identify properties of the functional female pelvic floor during pregnancy that could help to predict the mode of delivery. The functional capacity of the pelvic floor can be assessed by measuring pelvic floor muscle strength, and has been shown to be negatively associated with pelvic floor and sexual dysfunction. During labor, women’s pelvic floors must undergo modifications in order to allow fetal passage through the birth canal..The aim of this study is to correlate pelvic floor muscle contractility using digital assessment and the change in hiatal measurements using TPS, during maximum pelvic floor muscle contraction.

 
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