| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response (Others) - Nil
- What additional supporting information will be shared?
Response - Informed Consent Form Response (Others) - No
- Who will be able to view these files?
Response (Others) - Nil
- For what types of analyses will this data be available?
Response (Others) - No
- By what mechanism will data be made available?
Response (Others) - No
- For how long will this data be available start date provided 20-06-2024 and end date provided 20-06-2024?
Response (Others) - No
- 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  To study and compare the mode of delivery in women with PRLPP and without PRLPP.  To monitor the progress of labor in women delivering vaginally .  To record maternal and neonatal complications in perinatal peroid . Secondary objective  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 |