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

Completed

• Conditions: Pregnancy and Childbirth; Other puerperal infections; Maternal infections during childbirth

• Registration Number: ISRCTN03513186
• Lead Sponsor: John D and Catherine T MacArthur Foundation (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 6000

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Puerperal infections in women who deliver in study health facilities including <br>1.1. Bloodstream<br>1.2. Reproductive tract <br>1.3. Wound infections

Secondary Outcome Measures

Name	Time	Method
1. Antibiotic use<br>2. Duration of hospital stay