An infection control intervention study: Using infection control as an entry point for improving the quality of delivery care and strengthening health systems in developing countries
| ISRCTN | ISRCTN03513186 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03513186 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/10/2010
- Registration date
- 25/11/2010
- Last edited
- 10/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Julia Hussein
Scientific
Scientific
Immpact
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
| j.hussein@abdn.ac.uk |
Study information
| Study design | Interrupted time series with control |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet [in Gujarati and/or Hindi] |
| 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 |
| Study objectives | 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(s) | Prof Rajeev Sharma, Convenor of the Ethics committee, Indian Institute of Management, Ahmadabad, 23/09/2010 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2011 |
| Completion date | 01/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 6000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 01/09/2012 |
Locations
Countries of recruitment
- India
- Scotland
- United Kingdom
Study participating centre
Immpact
Aberdeen
AB25 2ZD
United Kingdom
AB25 2ZD
United Kingdom
Sponsor information
John D and Catherine T MacArthur Foundation (USA)
Charity
Charity
140 S. Dearborn Street
Chicago
IL 60603-5285
United States of America
| lyoung@macfound.org | |
| Website | http://www.macfound.org/ |
"ROR" |
https://ror.org/00dxczh48 |
Funders
Funder type
Charity
John D and Catherine T MacArthur Foundation (USA) (Grant number GSS 09-94513-000)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- MacArthur Foundation, John D. & Catherine T. MacArthur Foundation, JDCTMF
- Location
- United States of America
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/01/2014 | Yes | No |
