Longitudinal FolloW-up of Antimicrobial Resistance From Perinatal Acquisition (LWAPA): A SHARE Study ASSESSING AND PREVENTING Antimicrobial Resistance in the Perinatal Period

NCT ID: NCT06617260

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2027-02-28

Brief Summary

In 2022, in collaboration between the Botswana Ministry of Health (MOH), the U.S. Centers for Disease Control & Prevention, and the Botswana-UPenn Partnership (BUP), a program was launched called, "Surveillance of Healthcare-associated infections & Antimicrobial Resistance", or "SHARE". The aims of SHARE are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital epidemiology programs, leveraging data to prevent, detect, and contain emerging AMR threats; 3) deploy study teams to answer critical public health surveillance questions, and 4) to build a national network of hospital infection prevention and control (IPC) resources to prevent, detect, and contain emerging infectious disease threats.

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.

Conditions

Drug Resistance, Microbial

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: PROSPECTIVE

Study Groups

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:

• 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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 36 Weeks
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Ebbing Lautenbach

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Princess Marina Hospital

Gaborone, , Botswana

Countries

Botswana

Other Identifiers

Antimicrobial resistance(AMR),

Identifier Type: OTHER

Identifier Source: secondary_id

855283

Identifier Type: -

Identifier Source: org_study_id