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BabyGel Pilot: the provision of alcohol handgel to postpartum mothers in Mbale, Eastern Uganda to prevent neonatal infective morbidity in the home.

BabyGel Pilot: a pilot study of a cluster randomised trial of the provision of alcohol handgel to postpartum mothers in Mbale, Eastern Uganda to prevent neonatal infective morbidity in the home.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN67852437
Enrollment
100
Registered
2015-03-18
Start date
2015-04-01
Completion date
Unknown
Last updated
2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduction in infant (>3 months) sepsis thereby leading to a possible reduction in infant morbidity and mortality Infections and Infestations

Interventions

A pilot study of a cluster randomised trial of the provision of alcohol handgel to postpartum mothers to prevent neonatal infective morbidity in the home. This pilot study (work stream 1) will be used

Sponsors

University of Liverpool
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women with an estimated gestation of over 34 weeks 2. Reside in the participating villages. The gestation age will be determined by the Last Normal Menstruation period (LNMP), and or Ultra sound scan.

Exclusion criteria

Exclusion criteria: Women will be excluded from the study if they 1. Are temporary resident (visitors) in one of the Mbale villages 2. Plan to relocate to distant places (outside of the Mbale District) within 3 months of childbirth

Design outcomes

Primary

MeasureTime frame
1. Infant sepsis (using the Young Infant Clinical Signs Study Group (YICSSG) criteria 2. Sepsis death in the first 90 days of life (assessed using verbal autopsy)

Secondary

MeasureTime frame
Neonatal: Physician diagnosed infant infection, Microbiologically confirmed infant infection rate in the first 90 days of life (blood culture and cerebrospinal fluid), Infant mortality at 24hrs, 7 days, 4 weeks, and 3 months of life, Individual infant infections, General: fever, clinical jaundice, Infant weight and height at 3 months Maternal: Gel Hand hygiene compliance, frequency of other hand washing; Maternal postnatal pelvic infection, other infections and satisfaction.

Countries

Uganda, Uruguay

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026