Improving newborn care and outcomes through training of traditional birth attendants in use of bag and mask resuscitation in three rural districts in Bangladesh

ISRCTN	ISRCTN19619148
DOI	https://doi.org/10.1186/ISRCTN19619148
Secondary identifying numbers	03PC04

Submission date: 27/02/2009
Registration date: 06/04/2009
Last edited: 14/02/2020

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

Not provided at time of registration

Contact information

Prof Anthony Costello
Scientific

University College London (UCL) Institute of Child Health
Centre for International Health and Development
30 Guilford Street
London
WC1N 1EH
United Kingdom

Phone	+44 (0)20 7905 2883
Email	a.costello@ich.ucl.ac.uk

Study information

Study design	Cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Improving newborn care and outcomes through training of traditional birth attendants in use of bag and mask resuscitation in three rural districts in Bangladesh: a cluster randomised controlled trial
Study acronym	BADAS (Perinatal Care Project)
Study hypothesis	Will the training of traditional birth attendants (TBAs) in bag and mouth resuscitation improve newborn care and outcomes in three rural districts in Bangladesh?
Ethics approval(s)	1. Bangladesh Medical Research Council Ethics Committee gave approval on the 27th February 2005 (ref: BMRC/ERC/2004-2007/1132) 2. Great Ormond Street Hospital/Institute of Child Health Local Research Ethics Committee gave approval on the 14th March 2005 (ref: 03PC04)
Condition	Maternal and child health
Intervention	The TBAs in both the control and intervention areas all received a basic training package. The intention of the basic training package is for TBAs: 1. To be able to conduct clean and safe deliveries in the community 2. To be aware of danger signs during pregnancy, labour and the post-partum period 3. To increase awareness of danger signs among pregnant women and their families 4. To be prepared to act effectively in an emergency 5. To develop an emergency preparedness plan with pregnant women and their families 6. To refer women to health facilities in the case of emergencies 7. To accompany women who they refer to health facilities to provide additional support 8. To be able to resuscitate babies using mouth-to-mouth resuscitation In addition to the basic training package the selected TBAs in the intervention areas also received a bag and mask training package. The intention of this training package is to enable TBAs to resuscitate babies who are not breathing at one minute using a bag and mask. Refresher training is conducted for the basic and resuscitation training packages.
Intervention type	Other
Primary outcome measure	Newborn mortality, in particular asphyxia related deaths. Neonatal measured prospectively from 1st February 2005 until the end of the trial (31st December 2007). In the event of a stillbirth or a neonatal death, a verbal autopsy is completed, by the mother herself as well as by the health care provider (if present during delivery).
Secondary outcome measures	1. Maternal and neonatal home care practices 2. Utilisation of antenatal, delivery and postnatal services All outcomes measured prospectively from 1st February 2005 until the end of the trial (31st December 2007).
Overall study start date	01/02/2005
Overall study end date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	20,000 women, 480 TBAs trained
Participant inclusion criteria	1. Women who reside in one of the 18 study communities during the study period 2. Gave birth during the trial period
Participant exclusion criteria	1. Women who decline to be interviewed or reside outside the study area 2. Women residing in a Tea Estate
Recruitment start date	01/02/2005
Recruitment end date	31/12/2007

Locations

Countries of recruitment

Bangladesh
England
United Kingdom

Study participating centre

University College London (UCL) Institute of Child Health

London
WC1N 1EH
United Kingdom

Sponsor information

University College London (UCL) Institute of Child Health (UK)
Research organisation

c/o Professor Anthony Costello
Centre for International Health and Development
30 Guilford Street
London
WC1N 1EH
United Kingdom

Phone	+44 (0)20 7905 2883
Email	a.costello@ich.ucl.ac.uk
Website	http://www.ich.ucl.ac.uk/ich
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

Saving Newborn Lives (SNL) Initiative (Bangladesh) (ref: 264)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

14/02/2020: No publications found. All search options exhausted.