Autor/a:
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Madhi, Shabir A.; Rivera, Luis M.; Saez Llorens, Xavier; Menéndez, Clara; Carrim Ganey, Nazira; Cotton, Mark F.; Katzman, Darren; Luttig, Mariëtha M.; Candelario, Rosalba; Baker, Sherryl; Roychoudhury, Mahua
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Abstract:
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BACKGROUND: The successful implementation of maternal
vaccination relies on results of clinical trials, considering
the prenatal and postnatal attendance at selected healthcare
institutions. This study evaluated factors influencing
maternal/infant access to healthcare facilities to identify
potential barriers to participation in future clinical trials on
maternal vaccination. METHODS: In this prospective,
multi-centre, observational study, pregnant women (N = 3243)
were enrolled at ten sites across Panama, the Dominican
Republic, South Africa, and Mozambique between 2012 and 2014.
They completed questionnaires at enrolment, delivery, and infant
follow-up (90 days post-partum) visits, including questions on
transportation, phone accessibility, alternative childcare,
gestational age at enrolment, delivery location, and health
status of their infant. Logistic regression was used to identify
factors significantly associated with return to study site for
delivery or infant follow-up visits. RESULTS: Among 3229
enrolled women with delivery information, 63.6% (range across
sites: 25.3-91.5%) returned to study site for delivery. Older
women and those at later gestational age at enrolment were more
likely to deliver at the study site. While heterogeneities were
observed at site level, shorter travel time at delivery and
increased transportation costs at enrolment were associated with
increased likelihood of women returning to study site for
delivery. Among 3145 women with live-born infants, 3077 (95.3%)
provided 90-day follow-up information; of these, 68.9% (range
across sites: 25.6-98.9%) returned to study site for follow-up
visits. Women with other children and with lower transportation
costs at delivery were more likely to return to study site for
follow-up visits. Among 666 infants reported sick, 94.3% were
taken to a healthcare facility, with only 41.9% (range across
sites: 4.9-77.3%) to the study site. CONCLUSION: Although high
retention was observed from enrolment through 90 days after
delivery, post-partum surveillance should be broadened beyond
the study sites and additional follow-up visits should be
planned within the neonatal period. The factors influencing
maternal/infant access to healthcare facilities and the issues
identified in this study should be taken into consideration in
planning future clinical studies on maternal immunisation in
low- and middle-income countries. |