| CTRI Number |
CTRI/2019/07/020367 [Registered on: 25/07/2019] Trial Registered Prospectively |
| Last Modified On: |
19/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
care by birth companion during labour |
|
Scientific Title of Study
|
A Quasi-Experimental study to assess the effectiveness of doula care during intra-natal period on selected outcomes among labouring mothers admitted in CLR, Nehru Hospital, Chandigarh, 2018-20. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HEENA DEVI |
| Designation |
M.SC NURSING STUDENT |
| Affiliation |
NATIONAL INSTITUTE OF NURSING EDUCATION,PGIMER,CHANDIGARH |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh.
V.P.O SIDHPUR, TEH.DHARAMSHALA, DISTT. KANGRA, HIMACHAL PRADESH.
Kangra
HIMACHAL PRADESH
176057
India |
| Phone |
7018573267 |
| Fax |
|
| Email |
kapoorheena70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Sharma |
| Designation |
lecturer, NINE |
| Affiliation |
NATIONAL INSTITUTE OF NURSING EDUCATION,PGIMER,CHANDIGARH |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876269615 |
| Fax |
|
| Email |
sanitasuni@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
HEENA DEVI |
| Designation |
M.SC NURSING STUDENT |
| Affiliation |
NATIONAL INSTITUTE OF NURSING EDUCATION,PGIMER,CHANDIGARH |
| Address |
V.P.O SIDHPUR, TEH.DHARAMSHALA, DISTT. KANGRA, HIMACHAL PRADESH.
Kangra
HIMACHAL PRADESH
176057
India |
| Phone |
7018573267 |
| Fax |
|
| Email |
kapoorheena70@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing Education,PGIMER, CHANDIGARH. Pincode-160012 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF NURSING |
| Address |
NATIONAL INSTITUTE OF NURSING, PGIMER, CHANDIGARH-160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Heena Devi |
National Institute of Nursing Education, PGIMER |
CLR Nehru Hospital, PGIMER.
Chandigarh
CHANDIGARH |
7018573267
kapoorheena70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
WOMEN DURING LABOUR
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DOULA CARE PROTOCOL |
VERBAL ENCOURAGEMENT, INFORMATIVE SUPPORT, PSYCHOLOGICAL AND PHYSICAL SUPPORT |
| Comparator Agent |
ROUNTINE CARE |
support during labour, drug mangement. tramadol IV 50mg pethidine IV, 50mg. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ALL THE MOTHERS ADMITTED WITH 4CM CERVICAL DILATATION IN THE CLEAN LABOUR ROOM OF NEHRU HOSPITAL, PGIMER, CHANDIGARH. |
|
| ExclusionCriteria |
| Details |
MENTALLY UNHEALTHY WOMEN |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DECREASED DURATION OF LABOUR, PAIN MANAGEMENT DURING LABOUR, COMFORT DURING LABOUR |
after 1hr of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
good parenting
information regarding breast feeding |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/08/2019 |
| 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="1"
Months="2"
Days="22" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
this study wil be published in good articles and journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Quasi-Experimental study to assess the effectiveness of doula care during intra-natal period on selected outcomes among labouring mothers admitted in CLR, Nehru Hospital, Chandigarh, 2018-20. -[doula care, intra-natal period] a doula(birth companion) care interventions are given to the mothers during labour time for better labour outcomes and it will helps to reduce the anxiety and pain level among the mothers during labour and also increases the birth satisfaction/experience |