| CTRI Number |
CTRI/2025/07/090476 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Labour Supportive Measures for Labour Progress, Labour Pain and Maternal Satisfaction |
|
Scientific Title of Study
|
Effectiveness of Labour Supportive Measures on Selected Maternal Physiological Parameters Labour Pain and Maternal Satisfaction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF D REGINA RABELLO |
| Designation |
Dean Academics Nursing and Chief Nursing Superintendent |
| Affiliation |
HIND INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Nursing
Hind Institute of Medical Sciences
Mau Ataria Sitapur Road
Sitapur District Uttar Pradesh
Sitapur
UTTAR PRADESH
261304
India |
| Phone |
9044351500 |
| Fax |
- |
| Email |
deanacademics.nursing@himssitapur.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANJANA AGARWAL MBBS MS |
| Designation |
Professor and Head |
| Affiliation |
HIND INSTITUTE OF MEDICAL SCIENCES |
| Address |
Obstetrics and Gynecology Department
Hind Institute of Medical Sciences
Near Minor Canal
Safedabad Faizabad road
Barabanki Uttar Pradesh
Barabanki
UTTAR PRADESH
225003
India |
| Phone |
9415542356 |
| Fax |
- |
| Email |
anjana.agarwal98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF D REGINA RABELLO |
| Designation |
Dean Academics Nursing and Chief Nursing Superintendent |
| Affiliation |
HIND INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Nursing
Hind Institute of Medical Sciences
Mau Ataria Sitapur Road Sidhauli Sitapur District Uttar Pradesh
Sitapur
UTTAR PRADESH
261304
India |
| Phone |
9044351500 |
| Fax |
- |
| Email |
deanacademics.nursing@himssitapur.org |
|
|
Source of Monetary or Material Support
|
| Institution and hospitals where the study can be conducted.
Hind Institute of Medical Sciences, Uttar Pradesh. Community Health Centre, Sidhauli (CHC Sidhauli) Sitapur, Uttar Pradesh.
Material Support:
Birthball , Birthbar and Tennis Ball.
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Kumar Verma MBBS DA |
Cmmunity Health Center ,Sidhauli ,Sitapur |
Labour Room, CHC Sidhauli, Sitapur 261303
Sitapur
UTTAR PRADESH |
8429202591
chcsidhauli@gmail.com |
| Dr Anjana Agarwal MBBS MS |
Hind Institute of Medical Sciences |
Department of Obstetrics and Gynecology,
Near Minor Canal
Safedabad Faizabad road
Barabanki UP
Barabanki
UTTAR PRADESH |
9415542356
-
anjana.agarwal98@gmail.com |
| Prof D Regina Rabello |
Hind Institute of Medical Sciences |
Department of Nursing
Sitapur Road Mau Ataria Heerpur Sitapur 261303
Sitapur
UTTAR PRADESH |
9044351500
deanacademics.nursing@himssitapur.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Community Health Centre Sidhauli, Sitapur |
No Objection Certificate |
| Hind Institute of Medical Sciences, Barabanki, UP |
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 |
| Intervention |
Labour supportive measures such as Birth Ball in first stage Birth Bar in second stage Effleurage counter pressure and breathing patterns both first and second stage of labour will be adopted by the experimental group
Labour and delivery routine care will be given to the control group
General guideline for birth ball sizes correspond to maternal height
If the mother is 5 feet 4 inches or shorter 55 cm If the mother is 5 feet 4 to 10 inches 65 cm if the mother is 5 feet 10 inches or taller 75 cm
For the counter pressure method tennis ball will be used |
Tools of measurement are
1 Maternal Physiological Parameters are assessed through Bishops Score Partograph and APGAR score
2 Labor Pain is assessed through
VAS Visual Analogue Scale
McGill Pain Intensity Questionnaire and
Child Birth Comfort Questionnaire
3 Maternal satisfaction is assessed through Pushing perception Questionnaire
Child Birth Experience Questionnaire and
Maternal Satisfaction Questionnaire |
| Comparator Agent |
Labour supportive measures such as Birth Ball in first stage Birth Bar in second stage Effleurage counter pressure and breathing patterns both first and second stage of labour will not be given to the control group
Labour and delivery routine care will be given to the control group
|
Tools of measurement are
1 Maternal Physiological Parameters are assessed through Bishops Score Partograph and APGAR score
2 Labor Pain is assessed through
VAS Visual Analogue Scale
McGill Pain Intensity Questionnaire and
Child Birth Comfort Questionnaire
3 Maternal satisfaction is assessed through Pushing perception Questionnaire
Child Birth Experience Questionnaire and
Maternal Satisfaction Questionnaire |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
The inclusion criteria included the following
1.Pregnant Women with 18 years to 35 years
2.Low risk mothers having a healthy and uncomplicated pregnancy without any medical diagnosis
3.Anticipating vaginal delivery of a singleton fetus in cephalic presentation
at gestational-weeks between 37 and 41
4.The body mass index (BMI) of less than 30
5.The participants must understand Hindi and English to comprehend the Instructions |
|
| ExclusionCriteria |
| Details |
The exclusion criteria included the following
1.Pregnant Women who do not wish to give their Informed consent
2.Pregnant women with a history of high risk pertaining to complications.
3.Pregnant Women with the history of uterine scarring or any gynaecological disorders
4.Pregnant Women with labor complicated by her first stage
5.Medical contraindications if any
6.Foetus in mal presentations or malposition
7.Physical limitations that do not allow sitting or semi sitting position
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Improved Labor Progress, Painless labor and maternal satisfaction are the by far beneficial through these selected labor supportive measures. |
baseline and within 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ultimately these labour supportive measures will reduce the maternal morbidity and mortality. |
Data collection 2 years
Total study period : 5 years |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
15/07/2025 |
| 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="1"
Days="1" |
|
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 - NO
|
|
Brief Summary
|
Nurse researchers have categorized labor support in a variety of ways. The Cochrane Systematic Review on pain management for labor finds some evidence to suggest that relaxation, massage, Certain Evidence suggested Birth ball gives upright posture and Movements during first stage of labor and Birth bar provides comfortable moderately vertical Posturewhich may assist in the management of labor well. However, more research is needed to establish efficacy of these techniques.3 In response to the need to establish the evidence base for the interventions for Labor outcomes, pain management and better maternal satisfaction in labor, it is mandatory to undertook a randomised controlled trial to test the hypothesis that women who undergo a complementary Medicine antenatal and labor education course4. Selectively certain complementary medicine such as effleurage5,6, counter massage7,8, breathing patterns9,10,11and Evidence Based Practice suggested that Movement and Upright Posture12,13are effective in labor pain management. The effectiveness can be accessed through the Physiological Parameters, pain and Maternal satisfaction .Currently, there is a greater demand for this supportive measures in Midwifery.
|