Scaling up quality improvement for safer birth in public facilities of Nepal

ISRCTN	ISRCTN16741720
DOI	https://doi.org/10.1186/ISRCTN16741720
EudraCT/CTIS number	N/A
ClinicalTrials.gov number	N/A
Secondary identifying numbers	N/A

Submission date: 21/02/2019
Registration date: 02/03/2019
Last edited: 17/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Mothers and newborns are at the time of high risk of death during labour and first day of life. Reducing the risk of death will require improving care at the time of birth. We aim to conduct a study to evaluate a package of interventions that aims to improve the care at the time of birth.

Who can participate?
Women delivering in the hospital can participate in the study.

What does the study involve?
The study consists of implementation of package of quality improvement interventions. The quality improvement interventions consist of training, mentoring, weekly meeting and provision of equipment.

What are the possible benefits and risks of participating?
The intervention aims to improve the fetal heart rate monitoring, immediate newborn care, neonatal resuscitation and birth outcome. The risk of participating for women and children might be exposure to over-treatment.

Where is the study run from?
The study will be implemented in 8 public hospitals with delivery more than 3000 per year.

When is the study starting and how long is it expected to run for?
The study will start on 1 April 2019 and expected to end 15 December 2020.

Who is funding the study?
The study is funded by Government of Canada, Grand Challenges Canada.

Who is the main contact?
Rejina Gurung

Study website

Contact information

Dr Ashish KC
Public

Uppsala University, Uppsala, Sweden
Uppsala
751 05
Sweden

ORCID ID	0000-0002-0541-4486
Phone	9841453806
Email	ashish.k.c@kbh.uu.se

Mrs Rejina Gurung
Public

Golden Community
Lalitpur
977
Nepal

ORCID ID	0000-0002-4262-3543
Phone	+9779849979661
Email	rejugrg@hotmail.com

Study information

Study design	Stepped Wedged Cluster Randomized Controlled Trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in a web format, please use the contact details to request a participant information sheet
Scientific title	Scaling up safer birth bundle through quality improvement in Nepal: a stepped wedged cluster randomized controlled trial in public hospitals
Study acronym	SUSTAIN
Study objectives	Can a set of quality improvement interventions bundled with technology improve the quality of intrapartum care in public facilities of Nepal?
Ethics approval(s)	Approved 20/02/2019, Ethical Review Board of Nepal Health Research Council (Nepal Health Research Council, Ramshah Path, Kathmandu, Nepal, P.O.Box 7626; address-approval@nhrc.org.np; +977-4255987), ref: 110-2019.
Health condition(s) or problem(s) studied	Childbirth
Intervention	The SUSTAIN Package is a bundled kit of interventions which empower health care workers to efficiently monitor, provide care, and review care provided during the intrapartum and immediate postpartum period. The tools in this bundle (referred to as the Safer Births Bundle) are evidence-based and align with global guidelines. The interventions in the SUSTAIN package include training (Helping Babies Breathe Educational Program, NeoNatalie Advanced Newborn Ventilation Training Manikin), intrapartum monitoring (Moyo Fetal Heart Rate Monitor), postpartum care (Upright Newborn Bag Mask, NeoBeat Newborn Heart Rate Monitor), and a supporting system of review. Interventions include: 1. Perform a bottleneck analysis on the care of deliveries and set up a mechanism of continuous review and planning of care in the hospital to improve leadership accountability. 2. Introduce the Safer Births Bundle – a set of proven, cost-effective tools for training and therapy to improve labour monitoring (Moyo FHR Monitor) and neonatal resuscitation (Upright Bag-Mask, NeoBeat Newborn HR Meter, NeoNatalie LiveTraining Manikin)24. 3. Implement QI interventions in the delivery room including daily skill check for neonatal resuscitation, use of a checklist for the preparation for birth and resuscitation, use of self-review/evaluation checklist after conducting neonatal resuscitation, and weekly review meetings to track the progress made from the implementation of new tools and standards. 4. Set up a system of continuous measure & improve to assess the change in the quality of intrapartum care in the hospital by utilizing a Plan-Do-Study-Act (PDSA) approach. This approach harnesses local ownership of challenges and provides an actionable framework to monitor and evaluate progress to improve and sustain QI changes. This is a stepped wedge design. Where in the hospitals are clustered into different groups randomly. The interventions will be implemented in a stepped wedge manner, ie with a time lag of 2 months. The control area will be the total baseline period in the total hospital and the intervention area will be the total intervention period. Please see the figure. The 8 hospitals will be randomly allocated using a lottery technique.
Intervention type	Behavioural
Primary outcome measure	To be measured using patient record review: 1. Intrapartum stillbirth-In-utero fetal death during labour after 22 weeks of gestational age with no signs of life (no breathing or no heart rate until 10 minutes of life). 2. First-day neonatal mortality rate 3. Pre-discharge neonatal mortality-death of baby before discharge
Secondary outcome measures	1. Improvement in the proportion of delivery with fetal heart rate monitoring practice (every half an hour) will be determined using observation. 2. Improvement in the proportion of women to whom Moyo's FHMR is used to monitor fetal heart rate will be determined using observation. 3. Improvement in the proportion of babies heart rate monitored using neo-beat after birth will be determined using observation. 4. Whether maternity care was dignified will be determined by an interview with participating women. 5. Improvement in the proportion of non-breathing babies with bag and mask ventilation at 1 minute will be determined using observation. 6. Whether health workers are competent in neonatal resuscitation immediately after training will be determined using observation. 7. Whether health workers maintain neonatal resuscitation competency 6 months after training will be determined using observation during drills. 8. Whether health workers are competent in immediate newborn care will be determined using observation. 9. The proportion of health workers practicing skill drills in neonatalie at least 8 times in 3-month interval will be determined using observation. 10. The proportion of hospitals conducting bottleneck analysis and quality improvement plan development will be determined using observation.
Overall study start date	15/01/2019
Completion date	15/07/2021

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	89000 women
Key inclusion criteria	1. Women with gestational age ≥22 weeks 2. In labour
Key exclusion criteria	1. Referred from the labour room to operation theatre for delivery 2. Referred to other facilities 3. Do not have fetal heart sound at admission.
Date of first enrolment	01/04/2019
Date of final enrolment	01/07/2021

Locations

Countries of recruitment

Nepal

Study participating centres

Koshi Zonal hospital

Biratnagar
Province 1, Morang, Biratnagar
977
Nepal

Janakpur Zonal hospital

Janakpur
Province 2, Janakpur
977
Nepal

Bharatpur Hospital

Chitwan
Province 3, Bharapur
977
Nepal

Lumbini Zonal Hospital

Province 5, Lumbini
Lumbini
977
Nepal

Bheri Zonal hospital

Nepalgunj
Province 5, Bheri
977
Nepal

Mid-Western Regional Hospital

Surkhet
Surkhet road, Surkhet
977
Nepal

Seti Zonal hospital

Kailali
Dhangadi, Nepal
977
Nepal

Dadeldhura Sub-Regional Hospital

Dadeldhura
Province 7
977
Nepal

Sponsor information

Grand Challenges Canada
Government

-
Toronto
M4B 1B3
Canada

Email	ac.segnellahcdnarg@ofni
Website	https://www.grandchallenges.ca/contact-us/
"ROR"	https://ror.org/02snbhr24

Laerdal Foundation for Acute Medicine
Charity

Stavangar, Norway
Stavangar
4001
Norway

Phone	+47 90 28 28 55
Email	post@laerdalfoundation.org
Website	https://laerdalfoundation.org/

Funders

Funder type

Government

Grand Challenges Canada
Government organisation / National government

Alternative name(s): Grands Défis Canada, GCC
Location: Canada

Laerdal Foundation for Acute Medicine

No information available

Results and Publications

Intention to publish date	30/12/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	We aim to publish a process and impact evaluation in a peer-reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a secured repository of the Golden Community server and will be made public upon request. The participants location and identity will be anonymized. The datasets generated during and/or analysed during the current study will be stored in a secured repository of the Golden Community server. The access of the data will be with the data management officer-Omkar Basnet- basnetom21@gmail.com , interim analysis of the background characteristics and outcome will be done during study. The data will be not be made available until 15 July 2021.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file		21/02/2019	04/03/2019	No	No
Protocol article	protocol	19/06/2019	27/08/2019	Yes	No
Other publications	Nested prospective observational study	01/10/2020	31/10/2022	Yes	No

Additional files

ISRCTN16741720_PROTOCOL_21Feb19.pdf: Uploaded 04/03/2019

Editorial Notes

17/12/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/12/2020 to 01/07/2021.
2. The intention to publish date was changed from 15/06/2021 to 30/12/2021.
27/08/2019: Publication reference added.
08/03/2019: Internal review.
28/02/2019: Trial's existence confirmed by Janakpur Zonal Hospital and the Laerdal Foundation.