| CTRI Number |
CTRI/2024/01/061308 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [BIRTHING BALL] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of birthing ball usage during 1st stage of labor on selected maternal and fetal outcomes. |
|
Scientific Title of Study
|
A Randomized Controlled Trial to assess the effectiveness of birthing ball usage during 1st stage of labor on selected maternal and fetal outcomes among laboring women at tertiary care hospitals in Uttarakhand. |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHRUTI |
| Designation |
Post Graduate Student |
| Affiliation |
AIIMS, Rishikesh |
| Address |
College of Nursing AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7011240181 |
| Fax |
|
| Email |
jhashruti2498@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Prasuna Jelly |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
College of Nursing
AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9410103390 |
| Fax |
|
| Email |
prasunajelly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Prasuna Jelly |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
College of Nursing
AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9410103390 |
| Fax |
|
| Email |
prasunajelly@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [self funded research for completion of academic requirement] |
|
|
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 Prasuna Jelly |
AIIMS, Rishikesh |
College of Nursing, AIIMS, Rishikesh
Dehradun
UTTARANCHAL |
9410103390
prasunajelly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
The patients of Control Group would receive Routine medical and obstetrical care |
| Intervention |
Interventional Group |
the patients of Interventional Group would perform Exercises using Birthing Ball during 1st stage of labor |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Laboring women willing to participate in the study
Laboring women between 18 to 45 years of age
Laboring women in Third trimester with gestational age 29 to 42 weeks
Laboring women with cervical dilatation 4-8cm
Primigravida and multigravida women
Singleton pregnancy
Cephalic presentation
No contraindications for vaginal delivery
|
|
| ExclusionCriteria |
| Details |
Maternal or fetal complications: malpresentations, preterm rupture of membranes, cord prolapse
Any medical or obstetrical conditions: hypertensive disorders of pregnancy
Women planned for an elective cesarean section
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be significant relationship between birthing ball usage and selected maternal and fetal outcomes. |
2 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be no significant relationship between birthing ball usage and selected socio demographic profile |
2 years |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
15/01/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 - NO
|
Brief Summary
Modification(s)
|
A Randomized Controlled Trial to assess the effectiveness of birthing ball usage during 1st stage of labor on selected maternal and fetal outcomes among laboring women at a tertiary care hospital in Uttarakhand Where the pregnant women would be asked to sit on the birthing ball and perform exercises |