No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
45,450 (estimated)
Sponsor
University of California, Berkeley · Other
Who this trial is looking for
This trial is looking for pregnant women and their newborns at certain health care facilities in western Kenya. Participants will help test a method using chlorination to improve health and reduce infections for mothers and babies.
Are You a Good Fit for This Trial?
You may be able to join if
I am a pregnant adult or mature minor arriving at a participating facility.
I will give birth at one of the enrolled health care facilities.
You may not be able to join if
I had a miscarriage before 28 weeks of pregnancy.
I experienced a stillbirth.
I cannot give informed consent or do not consent.
I live more than 2 hours away from the facility.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The CLEAN (ChLorine to reduce Enteric and Antibiotic resistant infections in Neonates) cluster randomized controlled trial in western Kenya will evaluate the impact of a multi-component chlorination intervention in health care facilities on maternal and neonatal health. Intervention facilities will receive a passive chlorination technology for water supply treatment and a reliable supply of sodium…
The CLEAN (ChLorine to reduce Enteric and Antibiotic resistant infections in Neonates) cluster randomized controlled trial in western Kenya will evaluate the impact of a multi-component chlorination intervention in health care facilities on maternal and neonatal health. Intervention facilities will receive a passive chlorination technology for water supply treatment and a reliable supply of sodium hypochlorite disinfectant. Both intervention and treatment facilities will receive infection prevention and control messaging. The goal of the study is to evaluate the impact of the intervention on bacterial contamination of water supply, on staff hands, and on high-touch surfaces in maternity wards, and the following outcomes among facility-born neonates and their mothers: (1) gut carriage of bacterial pathogens associated with sepsis one week post-birth, (2) gut carriage of antibiotic resistant bacteria one week post-birth, and (3) symptoms of possible serious bacterial infection one week following birth.
Trial Locations
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Facility
City
State
Country
Status
Eligibility Criteria
Facility Inclusion Criteria:
* Public health care facility
* 25 live births or more per month
* Infrastructure compatible with inline chlorination device
Participant Inclusion Criteria:
* Pregnant adults/mature minors arriving at enrolled facilities to give birth and their neonates
Facility Excl…
Facility Inclusion Criteria:
* Public health care facility
* 25 live births or more per month
* Infrastructure compatible with inline chlorination device
Participant Inclusion Criteria:
* Pregnant adults/mature minors arriving at enrolled facilities to give birth and their neonates
Facility Exclusion Criteria:
* Existing facility-level chlorination
Participant Exclusion Criteria:
* Miscarriage (\<28 weeks gestation)
* Stillbirth (for neonatal analysis only)
* Unable to give informed consent/do not consent
* Reside \>2 hours away from facility for enrollment into swab sampling cohort
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