Contact information
Type
Scientific
Primary contact
Dr Julia Hussein
ORCID ID
Contact details
Immpact
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
j.hussein@abdn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An infection control intervention study incorporating an interrupted time series with control: Using infection control as an entry point for improving the quality of delivery care and strengthening health systems in developing countries
Acronym
Study hypothesis
The multifaceted strategy infection control package will result in the formulation and implementation of locally achievable and sustainable action to reduce rates of wound, bloodstream and reproductive tract infections after childbirth.
Ethics approval
Prof Rajeev Sharma, Convenor of the Ethics committee, Indian Institute of Management, Ahmadabad, 23/09/2010
Study design
Interrupted time series with control
Primary study design
Interventional
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet [in Gujarati and/or Hindi]
Condition
Maternal infections during childbirth
Intervention
Our intervention will have four core infection control elements, and a fifth element of appreciative inquiry as indicated below.
1. Improvement of surveillance systems for infection control
2. Operationalisation of infection control committees
3. Use of an audit, feedback, and problem solving mechanism
4. Development of locally relevant, standardised guidelines and protocols
5. Appreciative inquiry
Appreciative inquiry (AI) is a fairly new concept in infection control, and is the fundamental basis for our intervention. Appreciative inquiry hence brings together groups of people to identify problems and develop solutions, using self-reflective analysis and learning within a supportive environment. Sessions are held to include health facility personnel with diverse roles such as hospital cleaners, ambulance drivers, water engineer, nurses, doctors, administrators etc. Critical events are used in discussions which are non-threatening and non-punitive. Successes and problem-solving are the focus of discussions. In maternal health, it has been implemented at small scale to improve quality of emergency obstetric care in countries such as Bangladesh, India and Nepal. Although its effects were not evaluated formally in these settings, existing evidence suggest benefits of the approach.
We are planning to have 6 study sites of about 1000 deliveries per site, all in Gujarat state. They are a mix of government and private non profit health facilities. We hope to have 2 government and one PNP in each arm, control and intervention. The control facility will implement routine government procedures for infection control and will not receive the intensive surveillance-infection control committee-appreciative enquiry inputs.
The duration of the intervention and follow up will be 6 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Puerperal infections in women who deliver in study health facilities including
1.1. Bloodstream
1.2. Reproductive tract
1.3. Wound infections
Secondary outcome measures
1. Antibiotic use
2. Duration of hospital stay
Overall trial start date
01/01/2011
Overall trial end date
01/09/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women who delivered in the intervention and control hospitals (Gujarat state), who subsequently contract (puerperal) infection of the genital tract
2. Women in whom infections of the genital tract are identified after delivery, up to 42 days post partum
3. Puerperal infections are defined as those specified in ICD-10 codes 085 and 086 (see annex 1):
3.1. Puerperal sepsis
3.2. Other puerperal infections
3.3. Infection of obstetric surgical wound
3.4. Other infection of genital tract following delivery
3.5. Urinary tract infection following delivery
3.6. Other genital tract infection following delivery
3.7. Pyrexia of unknown origin following delivery
3.8. Other specified puerperal infections
4. Any woman over 28 weeks gestation who delivers a baby (live or stillborn) in any of the control or intervention hospitals
5. Any woman over 28 weeks gestation who has delivered a baby (in any location be it in the community, a study site or a non-study hospital) who is admitted with the placenta undelivered
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
6000
Participant exclusion criteria
1. Any woman who delivers a baby (live or stillborn) less than 28 weeks gestation.
2. Miscarriage and abortion cases
Note: Often, these cases are seen in out-patients or admitted in a different ward and are classified as 'gynaecologic' cases and not 'obstetric' cases
3. Any woman admitted to the study site after delivery of the placenta
Recruitment start date
01/01/2011
Recruitment end date
01/09/2012
Locations
Countries of recruitment
India
Trial participating centre
Immpact
Aberdeen
AB25 2ZD
United Kingdom
Sponsor information
Organisation
John D and Catherine T MacArthur Foundation (USA)
Sponsor details
140 S. Dearborn Street
Chicago
IL 60603-5285
United States of America
lyoung@macfound.org
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
John D and Catherine T MacArthur Foundation (USA) (Grant number GSS 09-94513-000)
Alternative name(s)
MacArthur Foundation, John D. & Catherine T. MacArthur Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24498089
Publication citations
-
Results
Hussein J, Ramani KV, Kanguru L, Patel K, Bell J, Patel P, Walker L, Mehta R, Mavalankar D, The effect of surveillance and appreciative inquiry on puerperal infections: a longitudinal cohort study in India., PLoS ONE, 2014, 9, 1, e87378, doi: 10.1371/journal.pone.0087378.