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
Official title: Longitudinal FolloW-up of Antimicrobial Resistance From Perinatal Acquisition (LWAPA): A SHARE Study ASSESSING AND PREVENTING Antimicrobial Resistance in the Perinatal Period
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Drug Resistance, Microbial
Keywords: Antimicrobial
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 36
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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 (\&amp;amp;gt;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

Brief summary: In 2022, in collaboration between the Botswana Ministry of Health (MOH), the U.S. Centers for Disease Control \&amp; Prevention, and the Botswana-UPenn Partnership (BUP), a program was launched called, "Surveillance of Healthcare-associated infections \&amp; 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.

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 (\&gt;41 weeks gestation)-

Exclusion Criteria:

Mothers/babies who have been admitted for more than 96 hours will be excluded

Primary outcomes:
measure: Antimicrobial resistance
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Princess Marina Hospital
Study officials:
References: