Condition category
Pregnancy and Childbirth
Date applied
11/09/2020
Date assigned
12/10/2020
Last edited
13/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
The number of stillbirths and newborn and maternal deaths is unacceptably high in low- and middle-income countries especially around the time of birth. Despite the existence of evidence-based training programs proven to reduce maternal and neonatal deaths, their full potential is often not realised due to scarce resources and support after implementation. The aim of this study is to determine the impact of scaling up the SaferBirths bundle of care (therapeutic and training) on improving the quality of intrapartum care and maternal and newborn survival.

Who can participate?
Women delivering in the hospital and their newborns in 30 hospitals in five regions in Tanzania

What does the study involve?
The SaferBirths Bundle is a well-proven package of innovative clinical tools (Moyo, upright bag and Neobeat) and training tools (MamaNatalie and Neonatalie live) coupled with low-dose high-frequency on-job training. The bundle is intended to better equip and train birth attendants to provide improved and timely quality care during labour and birth through a cascade of training and feedback loops.

What are the possible benefits and risks of participating?
The intervention aims to improve foetal heart rate monitoring, immediate newborn care, neonatal resuscitation and birth outcome. The benefits include quality and timely care of mothers and their newborns. The possible risks include over-treatment.

Where is the study run from?
Haydom Lutheran Hospital (Tanzania)

When is the study starting and how long is it expected to run for?
August 2020 to July 2023

Who is funding the study?
The Global Financing Facility for Women, Children and Adolescents (GFF) through the UNICEF Tanzania country office

Who is the main contact?
Benjamin Anathory Kamala
kamala8086@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Benjamin Kamala

ORCID ID

http://orcid.org/0000-0002-8969-2685

Contact details

PO Box 9000
Haydom
Manyara
-
Tanzania
+255 (0)713691949
kamala8086@gmail.com

Type

Public

Additional contact

Dr Paschal Mdoe

ORCID ID

Contact details

PO Box 9000
Haydom
Manyara
-
Tanzania
+255 (0)754429346
pfmdoe@gmail.com

Type

Scientific

Additional contact

Mr Estomih Mduma

ORCID ID

Contact details

PO Box 9000
Haydom
Manyara
-
Tanzania
+255 (0)755 876879
estomduma@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

01-SBB/HLH/2020

Study information

Scientific title

SaferBirths Bundle - keeping mothers and babies safe during and after birth: a stepped wedge cluster implementation project in selected public hospitals in Tanzania

Acronym

SaferBirths

Study hypothesis

Implementation of SaferBirths bundle of care will improve perinatal and maternal outcomes in public hospitals in Tanzania.

Ethics approval

Approved 30/05/2020, National Institute for Medical Research (3 Barack Obama Drive, PO Box 9653, 11101 Dar es Salaam, Tanzania; +255 (0)22 2121400; hq@nimr.or.tz, info@nimr.or.tz), ref: NIMR/HQ/R.8a/Vol. IX/3458

Study design

Stratified stepped-wedge cluster randomized quality improvement project

Primary study design

Interventional

Secondary study design

Stepped-wedge cluster randomized

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Childbirth

Intervention

The SaferBirths bundle of care is a combination of innovative clinical (therapeutic) and training tools tackling the main causes of perinatal death.

Moyo: an effective, user-friendly Fetal Heart Rate Monitor, suitable for low-resource settings. It can be used intermittently or continuously and provides audiovisual alarm, which enables HCW to detect abnormal fetal heart rate patterns earlier and more often compared to fetoscope and hand-held Doppler devices. Moyo facilitates more timely decision-making while reducing midwives' workload, as well as lessens maternal anxiety during labor as she can hear the heartbeat of her unborn baby.

NeoBeat Newborn Heart Rate Meter: a fast, easy and reusable device that provides an accurate and continuous display of a newborn's heart rate during the first seconds of life to remove misclassification and help guide resuscitation activities. Well-trained HCWs using NeoBeat can initiate ventilation of non-breathing newborns within the first minute of life.

Upright with PEEP Newborn Bag Mask: Compared to the horizontal bag-masks, the ergonomic orientation of the Upright bag-mask, and the new and improved Newborn Mask, are designed to make it easier to obtain mask seal and provide effective ventilation. Newborns with low-compliant (stiff) lungs are adequately ventilated with good outcomes using Upright with PEEP

NeoNatalie Live Newborn Resuscitation Trainer: NeoNatalie Live is a ‘smart’ simulator that provides feedback on key elements that providers often have difficulties with during newborn resuscitation. Each training session lasts less than 5 minutes and provides objective feedback on ventilation performance. This ensures greater flexibility to health care providers to train whenever their busy schedules allow them to. NeoNatalie Live also track of individual and team training progress over time. This enables providers as well as management to have a better overview of the number of providers trained, training progress, and areas of improvement. The SaferBirths innovations are not stand-alone products, but rather integrate with and support the existing evidence-based HBB training program. Experiences from implementation of HBB in Tanzania show that low-dose high-frequency training (LDHF) and a culture of continuous quality improvement (CQI) within the facility is essential for retaining and translating skills from training into clinical practice and for helping save lives The data-capturing components of the SaferBirths Bundle enable a system where HCW can receive objective feedback on their training as well as clinical quality of care. This not only helps guide their efforts, but also brings motivation to find ways to continually improve.

The study duration is 3 years.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Perinatal mortality defined as intrapartum stillbirth (i.e. stillborn baby with no signs of life at delivery and >28 weeks of gestation with intact skin and no signs of disintegration in utero) and neonatal death within the first 24 h of life, secondary to birth asphyxia, obtained from hospital records at the end of the study (3 years)

Secondary outcome measures

Obtained from hospital records at the end of the study (3 years):
1. Proportion of deliveries with fetal heart rate monitoring as per standard protocol, measured by fetal heart rate monitor (in beats per minute) during the study period
2. Proportion of deliveries in which neonates with an abnormal fetal heart rate during labor is followed by neonatal resuscitation using upright/standard bag during the study period
3. Proportion of deliveries resulting in emergency cesarean sections and instrumental deliveries by different causes during the study period
4. Proportion of non-breathing babies who receive bag and mask ventilation within 1 min of birth using upright/standard bag during the study period
5. Proportion of early neonatal morbidities, i.e. resuscitation, encephalopathy, low Apgar score, and admission to neonatal units during the study period
6. Proportion of mothers with postpartum haemorrhage managed successfully during the study period

Overall trial start date

01/08/2020

Overall trial end date

30/07/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Pregnant women in labor at gestation age of 28 weeks and above with a live foetus at recruitment

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

94,000 mother-newborn pairs

Participant exclusion criteria

1. Macerated stillbirths
2. Births below 28 weeks

Recruitment start date

19/01/2021

Recruitment end date

10/04/2023

Locations

Countries of recruitment

Tanzania

Trial participating centre

Haydom Lutheran Hospital
PO Box 9000 Haydom Mbulu
Manyara
255
Tanzania

Sponsor information

Organisation

Haydom Lutheran Hospital

Sponsor details

PO Box 9000
Haydom
Mbulu
-
Tanzania
+255 (0)272533194/5
post@haydom.co.tz

Sponsor type

Hospital/treatment centre

Website

http://www.haydom.com/

Funders

Funder type

Other

Funder name

Global Financing Facility for Women, Children and Adolescents (GFF) through the UNICEF Tanzania country office (PCA Reference: TZA/PCA202066)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol is not yet published but the study group intend to publish it. Once published it will be uploaded/made available to ISRCTN. The findings will be published as multiple papers in peer-reviewed relevant open-access international journals and communicated on global conferences. A summary in popular language will be developed for policymakers outlining the required quality improvement (QI) framework for improving care to advocate for more investments in such interventions. Combined workshops and dissemination seminars with relevant stakeholders will be conducted locally. The aim will be to summarise and discuss the findings from the ongoing data collection and related implications for operational changes in care at birth, as well as in development and implementation of PDSA cycles as part of CQI.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/07/2024

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/10/2020: The recruitment start date has been changed from 10/10/2020 to 19/01/2021. 14/09/2020: Trial's existence confirmed by National Institute for Medical Research, Tanzania.