Condition category
Pregnancy and Childbirth
Date applied
21/02/2019
Date assigned
02/03/2019
Last edited
08/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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

Trial website

N/A

Contact information

Type

Public

Primary contact

Dr Ashish KC

ORCID ID

http://orcid.org/0000-0002-0541-4486

Contact details

Uppsala University
Uppsala
Sweden
Uppsala
751 05
Sweden
9841453806
ashish.k.c@kbh.uu.se

Type

Public

Additional contact

Mrs Rejina Gurung

ORCID ID

http://orcid.org/0000-0002-4262-3543

Contact details

Golden Community
Lalitpur
977
Nepal
+9779849979661
rejugrg@hotmail.com

Additional identifiers

EudraCT number

N/A

ClinicalTrials.gov number

N/A

Protocol/serial number

N/A

Study information

Scientific title

Scaling up safer birth bundle through quality improvement in Nepal: a stepped wedged cluster randomized controlled trial in public hospitals

Acronym

SUSTAIN

Study hypothesis

Can a set of quality improvement interventions bundled with technology improve the quality of intrapartum care in public facilities of Nepal?

Ethics approval

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.

Study design

Stepped Wedged Cluster Randomized Controlled Trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in a web format, please use the contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

15/01/2019

Overall trial end date

15/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women with gestational age ≥22 weeks
2. In labour

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

89000 women

Participant 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.

Recruitment start date

01/04/2019

Recruitment end date

15/12/2020

Locations

Countries of recruitment

Nepal

Trial participating centre

Koshi Zonal hospital
Biratnagar
Province 1, Morang, Biratnagar
977
Nepal

Trial participating centre

Janakpur Zonal hospital
Janakpur
Province 2, Janakpur
977
Nepal

Trial participating centre

Bharatpur Hospital
Chitwan
Province 3, Bharapur
977
Nepal

Trial participating centre

Lumbini Zonal Hospital
Province 5, Lumbini
Lumbini
977
Nepal

Trial participating centre

Bheri Zonal hospital
Nepalgunj
Province 5, Bheri
977
Nepal

Trial participating centre

Mid-Western Regional Hospital
Surkhet
Surkhet road, Surkhet
977
Nepal

Trial participating centre

Seti Zonal hospital
Kailali
Dhangadi, Nepal
977
Nepal

Trial participating centre

Dadeldhura Sub-Regional Hospital
Dadeldhura
Province 7
977
Nepal

Sponsor information

Organisation

Grand Challenges Canada

Sponsor details

Toronto
Ontario
Canada
Toronto
M4B 1B3
Canada
-
ac.segnellahcdnarg@ofni

Sponsor type

Government

Website

https://www.grandchallenges.ca/contact-us/

Organisation

Laerdal Foundation for Acute Medicine

Sponsor details

Stavangar
Norway
Stavangar
4001
Norway
+47 90 28 28 55
post@laerdalfoundation.org

Sponsor type

Charity

Website

https://laerdalfoundation.org/

Funders

Funder type

Government

Funder name

Grand Challenges Canada

Alternative name(s)

Grands Défis Canada

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Funder name

Laerdal Foundation for Acute Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We aim to publish a process and impact evaluation in a peer-reviewed journal.

IPD sharing statement: 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.

Intention to publish date

15/06/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/03/2019: Internal review. 28/02/2019: Trial's existence confirmed by Janakpur Zonal Hospital and the Laerdal Foundation.