Condition category
Pregnancy and Childbirth
Date applied
27/02/2009
Date assigned
06/04/2009
Last edited
06/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anthony Costello

ORCID ID

Contact details

University College London (UCL) Institute of Child Health
Centre for International Health and Development
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2883
a.costello@ich.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

03PC04

Study information

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

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

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)

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/02/2005

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

20,000 women, 480 TBA’s trained

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

Trial participating centre

University College London (UCL) Institute of Child Health
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

c/o Professor Anthony Costello
Centre for International Health and Development
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2883
a.costello@ich.ucl.ac.uk

Sponsor type

Research organisation

Website

http://www.ich.ucl.ac.uk/ich

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes