Condition category
Pregnancy and Childbirth
Date applied
22/10/2010
Date assigned
25/11/2010
Last edited
10/09/2014
Prospective/Retrospective
Prospectively 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

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

http://www.macfound.org/

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

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

  1. 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.

Additional files

Editorial Notes