- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06617260
Longitudinal FolloW-up of Antimicrobial Resistance From Perinatal Acquisition (LWAPA): A SHARE Study ASSESSING AND PREVENTING Antimicrobial Resistance in the Perinatal Period (LWAPA)
Study Overview
Status
Conditions
Detailed Description
The Longitudinal FolloW-up of Antimicrobial Resistance from Perinatal Acquisition (LWAPA) study will assess the extent of perinatally-acquired MDROs and GBS, exploring factors influencing both maternal and neonatal colonization and better understanding the long-term outcomes in families affected by MDRO colonization.
By collecting samples at critical time points (e.g. during labour, after delivery, sequentially in the hospital, and then 3, 6, 9, and 12 months of age, the LWAPA study aims to identify modifiable factors influencing colonization risk. The results from this study can help inform and operationalize infection prevention measures which are poised to reduce the incidence of healthcare-associated infections and other poor health outcomes.
In Setswana, 'lwapa' means 'home' or 'family', which captures how this study aims to understand healthcare-associated AMR is impacting households and communities.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gaborone, Botswana, 267
- Princess Marina Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with:
- Pre-term labor (24-36 weeks gestation)
- Pre-eclampsia
- Post-dates (>41 weeks gestation) The rationale for recruiting these mothers is that there is a high probability of having a baby who will ultimately be admitted to the NNU
Description
Inclusion Criteria:
Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with:
- Pre-term labor (24-36 weeks gestation)
- Pre-eclampsia
- Post-dates (>41 weeks gestation)-
Exclusion Criteria:
Mothers/babies who have been admitted for more than 96 hours will be excluded
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Neonates and mothers
Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Longitudinal FolloW-up of Antimicrobial Resistance from Perinatal Acquisition
Time Frame: 12 months
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Ultimately, the goal of the LWAPA study is to better understand perinatal transmission of AMR in order to inform prevention measures
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12 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 855283
- Antimicrobial resistance(AMR), (Other Identifier: the U.S. Centers for Disease Control & Prevention)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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