| CTRI Number |
CTRI/2018/01/011434 [Registered on: 19/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
28/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Implementation research study adopting PDSA cycles |
| Study Design |
Other |
|
Public Title of Study
|
Improving Quality of Care for Mother and Newborn Care at Public Health Fcailities |
|
Scientific Title of Study
|
Improving Quality of Care for Mothers and Newborns at District Hospitals and FRUs of Three Districts of Haryana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manoja Kumar Das |
| Designation |
Director Projects |
| Affiliation |
The INCLEN Trust International |
| Address |
The INCLEN Trust International
F1/5, Okhla Industrial Area, Phase 1, New Delhi
South
DELHI
110020
India |
| Phone |
011-47730000 |
| Fax |
011-47730001 |
| Email |
manoj@inclentrust.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoja Kumar Das |
| Designation |
Director Projects |
| Affiliation |
The INCLEN Trust International |
| Address |
The INCLEN Trust International
F1/5, Okhla Industrial Area, Phase 1, New Delhi
South
DELHI
110020
India |
| Phone |
011-47730000 |
| Fax |
011-47730001 |
| Email |
manoj@inclentrust.org |
|
Details of Contact Person
Public Query
|
| Name |
Manoja Kumar Das |
| Designation |
Director Projects |
| Affiliation |
The INCLEN Trust International |
| Address |
The INCLEN Trust International
F1/5, Okhla Industrial Area, Phase 1, New Delhi
South
DELHI
110020
India |
| Phone |
011-47730000 |
| Fax |
011-47730001 |
| Email |
manoj@inclentrust.org |
|
|
Source of Monetary or Material Support
|
| World Health Organisation
20, Avenue Appia-CH-1211, Geneva 27, Switzerland |
|
|
Primary Sponsor
|
| Name |
World Health Organisation |
| Address |
World Health Organisation
20, Avenue Appia-CH-1211, Geneva 27, Switzerland |
| Type of Sponsor |
Other [UN organisation] |
|
|
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 Suresh Dalpath |
District hospital- Faridabad, Rewari and Jhajjar |
District Hospital, Faridabad
District Hospital, Rewari
District Hospital, Jhajjar
Faridabad
HARYANA |
9501650700
dhs.ddmch@hry.nic.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INCLEN Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (2) ICD-10 Condition: P84||Other problems with newborn, Pregnant women attending the hospitals for delivery and antenatal care and sick newborns admitted, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Pregnant women of any age attending the hospitals for ANC and delivery
Newborns (01 days to 28 days) attending the hospitals |
|
| ExclusionCriteria |
| Details |
Participants/LAR not giving consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in quality of care:
1. Maternal health care
•Delivery care
•Stillbirth rate
•Sepsis in postnatal period
•High risk screening
•Birth planning advice
2.Newborn health care
•Functional bags and masks
•Essential newborns care
•Skin-to-skin contact
•Facility NMR status
3. General health facility
•Stock-outs of essential medicines
•Maternal and perinatal death review
•Disinfection practices
•Uninterrupted oxygen supply
4.Client satisfaction |
Improvement in quality of care:
1. Maternal health care
•Delivery care
•Stillbirth rate
•Sepsis in postnatal period
•High risk screening
•Birth planning advice
2.Newborn health care
•Functional bags and masks
•Essential newborns care
•Skin-to-skin contact
•Facility NMR status
3. General health facility
•Stock-outs of essential medicines
•Maternal and perinatal death review
•Disinfection practices
•Uninterrupted oxygen supply
4.Client satisfaction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adoption and [practice of quality improvement processes at the facilities |
During the process of implementation |
|
|
Target Sample Size
|
Total Sample Size="480"
Sample Size from India="480"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2017 |
| Date of Study Completion (India) |
31/05/2019 |
| 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
|
Study protocol manuscript submitted for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objectives: This
implementation research focuses on improving quality of care for pregnant women
and their newborns in the three districts (Faridabad, Rewari and Jhajjar) of
Haryana. A total of 9 facilities including 3 district hospitals and 6 FRUs in
these three districts shall be part of the implementation research. The implementation research objectives are:
1. Design and implement context specific
interventions at these hospitals to improve the quality of care including
skilled attendance at birth, emergency obstetric care and sick newborn care.
2. Develop local capacity for quality improvement
processes for the maternal and newborn care.
3. Enhance local capacity to collect and use
information for continuous improvement
4.
To assess the feasibility, acceptability
and sustainability of the quality improvement interventions.
Study
design: This implementation research project shall adopt pre-post study design with repeated
observations comprising of mixed methodology (qualitative and quantitative).
For implementation of the interventions, we shall adopt continuous PDSA
(plan-do-study-act) cycle quality improvement approach.
Implementation: At the
selected facilities the service areas which will be included as part of the
quality improvement process are:
·
Maternal care: Labour room, operation
theatre, maternal ward and ANC OPDs
·
Newborn care: Sick newborn care units and
newborn stabilization units
The project shall be implemented in phases
over 24 months:
·
Phase 1- Formative research and
situational analysis (3 months)
·
Phase 2: Implementation of the improvement
cycles (15 months)
·
Phase 3: Documentation of impact (6
months)
·
Partners: The project is
being implemented with facilitation and support from National Health Mission, Government
of Haryana; Government of India, NSHRC, WHO and technical experts from several
medical colleges. Timeline: The implementation shall be done during April 2017- Mar 2019. |