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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
Intervention / Comparator Agent
|
|
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. |