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CTRI Number  CTRI/2024/07/071635 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Labor and delivery outcomes in lower back pain  
Scientific Title of Study   Impact of pregnancy related lumbopelvic pain on labor and delivery outcomes:Analytic cohort study . 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nasreen Chowdhary 
Designation  Junior resident  
Affiliation  Government medical college  
Address  Labor room ward 2 PGIMS Rohtak
Labor room
Rohtak
HARYANA
124001
India 
Phone  08082612258  
Fax    
Email  chowdharynasreen10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Reetu Hooda 
Designation  Professor  
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences,Rohtak 
Address  Ward 2 ,labor room ,PGIMS Rohtak
ward 2, PGIMS Rohtak
Rohtak
HARYANA
124001
India 
Phone  9996780344  
Fax    
Email  Drreetu2020@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Reetu Hooda  
Designation  Professor  
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences,Rohtak 
Address  Ward 2,labor room ,PGIMS Rohtak
ward 2, PGIMS Rohtak
Rohtak
HARYANA
124001
India 
Phone  08082612258  
Fax    
Email  Drreetu2020@gmail.com  
 
Source of Monetary or Material Support  
Ward 2 ,labor room ,PGIMS Rohtak ,Haryana,India with pincode 124001. 
 
Primary Sponsor  
Name  Pgims Rohtak 
Address  Ward 2 ,labor room ,PGIMS Rohtak 
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 
Dr Nasreen Chowdhary   Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences,Rohtak  Room no 74,Ganga hostel ,ward 2 ,labor room PGIMS Rohtak
Rohtak
HARYANA 
08082612258

chowdharynasreen10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O288||Other abnormal findings on antenatal screening of mother,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  With recurrent or persistent pregnancy-related lumbopelvic pain 
 
ExclusionCriteria 
Details  Ortho condition
Infection
Trauma
Tumor 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
c section
Normal birth
Duration of labor 
4-6weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Pain 24hrs after delivery
Impact on breastfeeding  
Pain 24hrs after delivery
Impact on breastfeeding  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   12/08/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 (Others) -  Nil

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response (Others) -  No
  3. Who will be able to view these files?
    Response (Others) -  Nil

  4. For what types of analyses will this data be available?
    Response (Others) -  No

  5. By what mechanism will data be made available?
    Response (Others) -  No

  6. For how long will this data be available start date provided 20-06-2024 and end date provided 20-06-2024?
    Response (Others) -  No

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary    Title :Impact of pregnancy  Related lumbopelvic pain on labor and delivery Outcomes.

 Low back pain (LBP) has been defined as any discomfort or pain between the 12th rib and  the gluteal fold .

Another term lumbopelvic (LPP) pain is defined as recurrent or constant pain 
for more than 1 week in lumbopelvic region during pregnancy.

Pelvic girdle pain (PGP) is another type of pain which is described by some authors, as pain localized in the sacroiliac joint’s area, with or without involvement of posterior thigh and pubic symphysis. In the past literature though the classification remained uncertain, in a recent consensus paper it is stated that PGP should be considered as a specific form of LBP that can occur alone or in combination to LBP.LBP is a very common problem which leads to significant social and economic costs worldwide,As per current literature, prevalence in Pregnant women varies, most studies report a prevalence of about 50 to 86 percent. 
Former LBP episodes and previous pregnancies LBP are not linked to period of gestation, any previous back or pelvis trauma, strenuous working activity, and  fetomaternal weight ,Evidences show that physical exercise during pregnancy and delivery outcomes are strictly related to each other 6-13. Besides all the expected advantages of physical activity on maternal and fetal metabolic balance, it is known that labor’s coping strategies, childbirth dynamics, and mode of delivery can b interfered by presence of LBP during pregnancy.
PGP and PLBP usually starts around 8th week of pregnancy and peak intensity between 24th -36th week, but it can also start in the first trimester or be delayed as late as three weeks after delivery.Women with PGP and PLBP find difficulty with normal activities such as getting up from sitting position, turning over bed, prolonged sitting, pro nalyse the labor and delvery outcomes in women with pregnancy rated
lumbopelvic pain (PRLPP) and compare with women without PRLPP.
OBJECTIVE
Primary Objectives
ï‚· To study and compare the mode of delivery in women with PRLPP and without
PRLPP.
ï‚· To monitor the progress of labor in women delivering vaginally .
ï‚· To record maternal and neonatal complications in perinatal peroid .
Secondary objective
ï‚· To assess the impact of lumbopelvic pain in immediate postpartum.
INCLUSION CRITERIA
Antenatal women with singleton pregnancy with a history of PRLPP in the current pregnancy
would be enrolled for the study at gestational age >=34weeks and before onset of labor.
Study population:
Study cohort: Antenatal women with history of PRLPP in current pregnancy.
Comparison cohort :Antenatal women without PRLPP

Sample size :200 
100 will be with pain
100 without pain 
 
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