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CTRI Number  CTRI/2024/09/074226 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Physiotherapy (Not Including YOGA)
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of perineal massage in pregnancy on birth related perineal injuries Randomised controlled trial 
Scientific Title of Study   Effect of antenatal perineal massage on vaginal birth related perineal trauma in primiparae -Randomised control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Drishti chola 
Designation  Post graduate Resident 
Affiliation  Lady Hardinge Medical College & Smt sucheta kriplani hospital 
Address  ANC OPD room no 233 Department of obstetrics and gynaecology Lady Hardinge Medical College & Smt sucheta kriplani hospital Near, Panchkuian Marg,Shivaji Stadium, Connaught Place, New Delhi,

Central
DELHI
110001
India 
Phone  8076641808  
Fax    
Email  drishtichola147@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anuradha Singh 
Designation  professor 
Affiliation  Lady Hardinge Medical College 
Address  ANC OPD room no 233 Department of obstetrics and gynaecology obs unit Lady Hardinge Medical College & Smt sucheta kriplani hospital Near, Panchkuian Marg,Shivaji Stadium, Connaught Place, New Delhi,

Central
DELHI
110001
India 
Phone  9711502439  
Fax    
Email  dranuradhalhmc80@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Drishti chola  
Designation  Post graduate Resident 
Affiliation  Lady Hardinge Medical College 
Address  ANC OPD room no 233 Department of obstetrics and gynaecology obs unit Lady Hardinge Medical College & Smt sucheta kriplani hospital Near, Panchkuian Marg,Shivaji Stadium, Connaught Place, New Delhi,

Central
DELHI
110001
India 
Phone  8076641808  
Fax    
Email  drishtichola147@gmail.com  
 
Source of Monetary or Material Support  
Lady hardinge medical college and smt sucheta kriplani hospital ,connaught place,NewDelhi-110001 India 
 
Primary Sponsor  
Name  Lady Hardinge Medical College,  
Address  Near, Panchkuian Marg,Shivaji Stadium, Connaught Place, New Delhi, Delhi 110055 
Type of Sponsor  Government medical college 
 
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 
DRISHTI CHOLA  Lady Hardinge Medical college and Smt Sucheta Kriplani Hospital  room no 233,ANC OPD, obs unit Department of obstetrics and gynaecology ,LHMC and SSKH Near, Panchkuian Marg,Shivaji Stadium, Connaught Place, New Delhi-110001
Central
DELHI 
8076641808

drishtichola147@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,lady hardinge medical college & associated hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O709||Perineal laceration during delivery, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Antepartum perineal massage  group A will recieve antepartum perineal massage starting at 34 weeks till term 
Comparator Agent  No antepartum perineal massage  group B will not recieve antepartum perineal massage,they will recieve routine maternal care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  all low risk primigravida between 34-36 weeks of gestation with single live foetus in cephalic presentation 
 
ExclusionCriteria 
Details  All high risk primigravida and primigravida with diagnosed pelvic floor dysfunction .Previous history of perineal trauma and expected foetal weight more than 95th centile for that gestation .Presence of pre-existing genital infections.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of women in both groups who will have perineal laceration .  Intrapartum period /during delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of women in both groups experiencing episiotomy and perineal pain at 48 hours postpartum and
• Proportion of women in both groups having prolonged second stage of labour (more than 2 hours) 
During 2 nd stage of labour and 48 hrs post partum 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   04/10/2024 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   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
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [drishtichola@147@gmail.com].

  6. For how long will this data be available start date provided 03-09-2024 and end date provided 03-09-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - drishtichola147@gmail.com
Brief Summary  

Intrapartum injuries are a topic of concern for women during childbirth especially those who are   conceiving for the first time. It occur as a result of inelastic perineum ,long second stage of labor ,inadequate perineal support and large size of baby. Perinatal injuries can cause short term and long term complications .It includes bleeding, pain ,infections ,hematoma and discomfort in early post partum period  . It can also result in urinary and fecal incontinence in long term   .It also affects the quality of life and are known to cause sexual dysfunction in women. 

 Antepartum perineal massage reduces the risk of intrapartum tears, perineal pain and rate of episiotomies during labor. Many international studies are already done which support this but there is scarcity of Indian data.

HYPOTHESIS  Antepartum perineal massage is effective in decreasing the frequency of vaginal birth related perineal injuries in primiparae as compared to women who do not receive antepartum perineal massage .

AIM To study the effect of antepartum perineal massage on vaginal birth related perineal trauma .

PRIMARY OBJECTIVE  To compare the frequency of perineal tears, in women who will receive antepartum perineal message as compared to women who will not receive antepartum perineal massage.

 SECONDARY OBJECTIVE To compare the duration of 2nd stage of labor(in minutes), rates of episiotomy and perineal pain  at  48 hours  in postpartum period in study and control group .

This study will be carried out after prior approval from the Institutional Ethical and Research committee.

STUDY DESIGN- Randomised control trial

PLACE OF STUDY-ANC OPD of obstetrics and gynaecology at   Lady Hardinge medical college and SSK hospital, Delhi

INCLUSION CRITERIA All low risk primigravida  between  34-36 weeks of gestation with single live fetus in cephalic presentation between the age of 18 and 35 years.

EXCLUSION CRITERIA

        All high risk primigravida .

         All primigravida with diagnosed pelvic floor dysfunction and preexisting genital infections.

        Previous history of perineal trauma and   Expected fetal  weight more than 95th centile for that gestation

SAMPLE SIZE ESTIMATION- 55 per group

          METHODOLOGY

        An informed consent will be taken from all the eligible women fulfilling inclusion criteria .The participants will be selected in both groups based on systematic random sampling technique.

        Participants will be explained about benefits and technique of antepartum perineal message using pictorial charts.

        Randomization: Using sequential computer-generated block randomization (block size of four) study participants will be divided into two groups, study group (receiving intervention of antepartum perineal massage) and control group (not receiving antepartum perineal massage), with 1:1 allocation ratio. Allocation will be concealed with the use of sequential numbered opaque envelopes. Allocation will be done by candidate. Participants & investigator delivering intervention as well as assessing outcome will be aware about the intervention being received. Data Analyst will be blinded to the allocation.

       Detailed history will be taken and detailed examination including ,general physical examination  ,systemic examination ,obstetric examination  will be  done.

      They will be given supervised session of antepartum massage at every OPD visit and explained to perform the same at home .

      They are asked to give self massage at home once before next visit .Enrolled women will be followed up weekly and then compliance will be checked.

        Antepartum perineal  massage will be done  twice a week for 10 mins  till delivery.

        Control group will not receive antepartum perineal massage.

        Both the groups will be managed as per standard protocol and followed up  weekly till  delivery and 48hrs postpartum .

        All women who will have Preterm vaginal delivery and LSCS  will be excluded from the study.

        Normal vaginal delivery will be conducted by  residents posted in labor room and  trained in conducting vaginal deliveries.

        Delivery details and duration of second stage of labor ( in minutes) will be recorded , it lasts for 2 hours in nulliparas (median 50 minutes).

        Assessment of pain will be done at 48 hours postpartum using VAS Pain score of (1-10).The mean pain score of two groups will be calculated .

         The visual analog scale(VAS) is a validated, subjective measure for pain. Scores are recorded by making mark on a 10-cm line that represents a continuum between “no pain” and “worst pain”. The VAS takes < 1minute to complete.

        The data will be subjected to statistical analysis.



 STEPS OF ANTEPARTUM PERINEAL MASSAGE 

      Women will be asked to lie in comfortable and relaxed position .Propped  up position with  back supported and wide apart legs flexed at knees and hip joint.

      Researcher will do antepartum massage under all aseptic precaution with gloved hands and using 2% lignocaine jelly, thumbs of both hands will be inserted  in the vagina to a depth of 3 to 5 cms and pressed down towards the anus and to the sides of the vaginal walls. The  thumbs will be held in this position for about 1 minute  until a slight burning ,tingling sensation is felt .

      Gentle massage will be done in the lower half of vagina using a U shaped movement for 2-3 minutes and repeated 2-3 times.

      Massage can be done in one direction at a time i.e. from side to side or the thumbs can be swept in opposite direction. The message will be done for 10 minutes

      Simultaneously relaxed breathing is advised to relax the pelvic floor muscles and allowing the tissues to stretch.

      Women will be advised to repeat the massage once at home before coming to next OPD visit . They are advised to wash hands and can use a lubricant like coconut oil .

 

 

 

 

 

 

 

 

 


 
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