| CTRI Number |
CTRI/2020/09/027738 [Registered on: 10/09/2020] Trial Registered Prospectively |
| Last Modified On: |
30/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Birth Companionship During Labor |
|
Scientific Title of Study
|
Birth Companionship During Labor: A Quality Improvement Study In A Tertiary Care Center Of Uttarakhand |
| Trial Acronym |
BICOL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhulika Singh |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
C/O DR LATIKA CHAWLA, ASSISTANT PROFESSOR, DEPARTMENT OF AIIMS RISHIKESH, VEERBHADRA ROAD, RISHIKESH, DEHRADUN, UTTARAKHAND
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7579887727 |
| Fax |
|
| Email |
drmadhulikamksingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhulika Singh |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
C/O DR LATIKA CHAWLA, ASSISTANT PROFESSOR, DEPARTMENT OF AIIMS RISHIKESH, VEERBHADRA ROAD, RISHIKESH, DEHRADUN, UTTARAKHAND
AIIMS Rishikesh, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7579887727 |
| Fax |
|
| Email |
drmadhulikamksingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Latika Chawla |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS |
| Address |
Department of Obstetrics & Gynecology, AIIMS, Rishikesh, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9013074659 |
| Fax |
|
| Email |
latika.c@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS RISHIKESH |
| Address |
AIIMS RISHIKESH, VEERBHADRA ROAD, RISHIKESH, DEHRADUN, UTTARAKHAND |
| 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 |
| Madhulika Singh |
AIIMS Rishikesh |
Labour room, Department of Obstetrics & Gynaecology, AIIMS Rishikesh, Veerbhardra road, Rishikesh, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL |
7579887727
drmadhulikamksingh@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: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No control group |
This is a Quality Improvement study. We are aiming at 90% Birth Companionship during labor & childbirth. |
| Intervention |
Presence of Birth Companion |
Birth Companion will be allowed to accompany Laboring women & during delivery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Antenatal patients delivering vaginally in labour room of Department of Obstetrics and Gynaecology, AIIMS Rishikesh.
2.Antenatal patients who wish/choose to have a birth companion
3.Patient without any on-going intra-partum or postpartum complication
|
|
| ExclusionCriteria |
| Details |
1.Antenatal patients who do not wish to have a birth companion
2.Antenatal patients undergoing instrumental vaginal delivery / caesarean section
3.Covid-19 positive patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of women accompanied by birth companion during labour |
1 1/2 years from the date of Ethical clearance |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure pain perception during labour (VAS Score) |
1 1/2 years from the date of Ethical clearance |
| Duration of second stage of labour (in minutes) |
1 1/2 years from the date of Ethical clearance |
| Maternal satisfaction during labour (Birth Satisfaction Scale- Revised Indicator [BSS-RI]) |
1 1/2 years from the date of Ethical clearance |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="345" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2020 |
| Date of Study Completion (India) |
15/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a Prospective Quality Improvement Study. This study promotes Respectful Maternity Care. · Women delivering in labour room of Department of Obstetrics and Gynaecology, AIIMS, Rishikesh will be included in this study as per inclusion and exclusion criteria. Our objective is to ensure that 90% of all women delivering at our facility had a birth companion by their side during labour and delivery. This Quality Improvement (QI) study will follow 4 step approaches as given by Point of Care Continuous Quality Improvement (POCCQI) manual by WHO, using the standard tools for quality improvement for data collection and statistical analysis, namely Step 1 Identifying the problem, forming a team, aim statement Step 2 Analysing and measuring quality of care Step 3 Developing and testing changes Step 4 Sustaining improvement |