CompletedPhase 2/3

Zambia Chlorhexidine Application Trial

Zambia77,535 participantsStarted 2011-02

Plain-language summary

This will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when compared to the current standard of care, dry cord care.

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pregnant women in the 2nd or 3rd trimester * Age 15 years and above * Pregnant women who plan to stay in the study area (catchment area of the health facility) for delivery and one month post partum * Willingness to provide cord care as per the protocol of their cluster * Willingness to provide informed consent Exclusion Criteria: * Pregnant women who are not willing to provide cord care as per the protocol of their cluster * Pregnant women who are not willing to provide informed consent * Pregnant women in the 1st trimester * Pregnant women under age 15 years

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

All-cause Neonatal Mortality

Timeframe: 28 days post-partum

All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life

Timeframe: 28 days post-partum

Trial details

NCT IDNCT01241318

SponsorBoston University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-09

Results submitted2016-12-09

View on ClinicalTrials.gov More Sepsis trials

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.