Short- and mid-term morbidity and primary-care burden due to infant respiratory syncytial virus infection: A Spanish 6-year population-based longitudinal study.

BACKGROUND: The morbidity burden of respiratory syncytial virus (RSV) in infants extends beyond hospitalization. Defining the RSV burden before implementing prophylaxis programs is essential for evaluating any potential impact on short- to mid-term morbidity and the utilization of primary healthcare (PHC) and emergency services (ES). We established this reference data using a population-based cohort approach. METHODS: Infants hospitalized for RSV from January 2016 to March 2023 were matched with non-hospitalized ones based on birthdate and sex. We defined the exposure as severe RSV hospitalization. The main study outcomes were as follows: (1) PHC and ES visits for RSV, categorized using the International Classification of Primary Care codes, (2) prescriptions for respiratory airway obstructive disease, and (3) antibacterial prescriptions. Participants were followed up from 30 days before hospitalization for severe RSV until the outcome occurrence or end of the study. Adjusted incidence rate ratios (IRRs) of the outcomes along with their 95% confidence intervals (CI) were estimated using Poisson regression models. Stratified analyses by type of PHC visit (nurse, pediatrician, or pharmacy) and follow-up period were undertaken. We defined mid-term outcomes as those taking place up to 24 months of follow-up period. RESULTS: The study included 6626 children (3313 RSV-hospitalized; 3313 non-hospitalized) with a median follow-up of 53.7 months (IQR = 27.9, 69.4). After a 3-month follow-up, severe RSV was associated with a considerable increase in PHC visits for wheezing/asthma (IRR = 4.31, 95% CI: 3.84-4.84), lower respiratory infections (IRR = 4.91, 95% CI: 4.34-5.58), and bronchiolitis (IRR = 4.68, 95% CI: 2.93-7.65). Severe RSV was also associated with more PHC visits for the pediatrician (IRR = 2.00, 95% CI: 1.96-2.05), nurse (IRR = 1.89, 95% CI: 1.75-1.92), hospital emergency (IRR = 2.39, 95% CI: 2.17-2.63), primary healthcare emergency (IRR: 1.54, 95% CI: 1.31-1.82), as well as with important increase in prescriptions for obstructive airway diseases (IRR = 5.98, 95% CI: 5.43-6.60) and antibacterials (IRR = 4.02, 95% CI: 3.38-4.81). All findings remained substantial until 2 years of post-infection. CONCLUSIONS: Severe RSV infection in infants significantly increases short- to mid-term respiratory morbidity leading to an escalation in healthcare utilization (PHC/ES attendance) and medication prescriptions for up to 2 years afterward. Our approach could be useful in assessing the impact and cost-effectiveness of RSV prevention programs.

Effectiveness and impact of universal prophylaxis with nirsevimab in infants against hospitalisation for respiratory syncytial virus in Galicia, Spain: initial results of a population-based longitudinal study.

BACKGROUND: Galicia (Spain) was one of the first regions worldwide to incorporate nirsevimab for universal respiratory syncytial virus (RSV) prophylaxis in infants into its immunisation programme. The NIRSE-GAL longitudinal population-based study aimed to assess nirsevimab effectiveness in preventing hospitalisations (ie, admittance to hospital). METHODS: The 2023-24 immunisation campaign with nirsevimab in Galicia began on Sept 25, 2023, and concluded on March 31, 2024. The campaign targeted three groups: infants born during the campaign (seasonal group), infants younger than 6 months at the start of the campaign (catch-up group), and infants aged 6-24 months with high-risk factors at the start of the campaign (high-risk group). Infants in the seasonal group were offered immunisation on the first day of life before discharge from hospital. Infants in the catch-up and high-risk groups received electronic appointments to attend a public hospital or health-care centre for nirsevimab administration. For this interim analysis, we used data collected from Sept 25 to Dec 31, 2023, from children born up to Dec 15, 2023. Data were retrieved from public health registries. Nirsevimab effectiveness in preventing RSV-associated lower respiratory tract infection (LRTI) hospitalisations; severe RSV-related LRTI requiring intensive care unit admission, mechanical ventilation, or oxygen support; all-cause LRTI hospitalisations; and all-cause hospitalisations was estimated using adjusted Poisson regression models. Data from five past RSV seasons (2016-17, 2017-18, 2018-19, 2019-20, and 2022-23), excluding the COVID-19 pandemic period, were used to estimate the number of RSV-related LRTI hospitalisations averted along with its IQR. The number needed to immunise to avoid one case in the 2023-24 season was then estimated from the averted cases. Nirsevimab safety was routinely monitored. The NIRSE-GAL study protocol was registered on ClinicalTrials.gov (NCT06180993), and follow-up of participants is ongoing. FINDINGS: 9408 (91·7%) of 10 259 eligible infants in the seasonal and catch-up groups received nirsevimab, including 6220 (89·9%) of 6919 in the seasonal group and 3188 (95·4%) of 3340 in the catch-up group. 360 in the high-risk group were offered nirsevimab, 348 (97%) of whom received it. Only infants in the seasonal and catch-up groups were included in analyses to estimate nirsevimab effectiveness and impact because there were too few events in the high-risk group. In the catch-up and seasonal groups combined, 30 (0·3%) of 9408 infants who received nirsevimab and 16 (1·9%) of 851 who did not receive nirsevimab were hospitalised for RSV-related LRTI, corresponding to an effectiveness of 82·0% (95% CI 65·6-90·2). Effectiveness was 86·9% (69·1-94·2) against severe RSV-related LRTI requiring oxygen support, 69·2% (55·9-78·0) against all-cause LRTI hospitalisations, and 66·2% (56·0-73·7) against all-cause hospitalisations. Nirsevimab effectiveness against other endpoints of severe RSV-related LRTI could not be estimated because of too few events. RSV-related LRTI hospitalisations were reduced by 89·8% (IQR 87·5-90·3), and the number needed to immunise to avoid one RSV-related LRTI hospitalisation was 25 (IQR 24-32). No severe adverse events related to nirsevimab were registered. INTERPRETATION: Nirsevimab substantially reduced infant hospitalisations for RSV-associated LRTI, severe RSV-associated LRTI requiring oxygen, and all-cause LRTI when given in real-world conditions. These findings offer policy makers and health authorities robust, real-world, population-based evidence to guide the development of strategies for RSV prevention. FUNDING: Sanofi and AstraZeneca. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

Assessment of effectiveness and impact of universal prophylaxis with nirsevimab for prevention of hospitalizations due to respiratory syncytial virus in infants. The NIRSE-GAL study protocol.

Nirsevimab has been recently licensed for universal RSV prophylaxis in infants. NIRSE-GAL is a three-year population-based study initiated in Galicia in September 2023. It aims to evaluate nirsevimab effectiveness against RSV-related hospitalizations lower respiratory tract infections (LRTI), severe RSV, all-cause LRTI, and all-cause hospitalization. NIRSE-GAL also aims to estimate nirsevimab impact on primary healthcare use in the short and mid-term, children's wheezing and asthma, and medical prescriptions for RSV. The immunization campaigns will be scheduled based on the expected start week for the RSV season and will last the whole season. Immunization will be offered to: i) infants born during the campaign (seasonal), ii) infants < 6 months at the start of the campaign (catch-up), and iii) infants with high-risk factors, aged 6-24 months at the start of the campaign (high-risk). The follow-up period will start: i) the immunization date for all immunized infants, ii) the start of the campaign, for the non-immunized catch-up or high-risk groups, or iii) the birthdate for the non-immunized seasonal group. Infants will be followed up until outcome occurrence, death, or end of study. Nirsevimab effectiveness will be estimated using Poisson and Cox regression models. Sensitivity and stratified analyses will be undertaken. The number of averted cases and the number needed to immunize will be estimated. Immunization failure and nirsevimab safety will be monitored. NIRSE-GAL was approved by the ethics committee of Galicia (CEIC 2023-377) and registered in ClinicalTrials.gov (ID: NCT06180993). Findings will be mainly shared via peer-reviewed publications and scientific conferences.

COVID-19 vaccine effectiveness in children by age groups. A population-based study in Galicia, Spain.

BACKGROUND: Studies on vaccine effectiveness (VE) against COVID-19 in the pediatric population are outgoing. We aimed to quantify VE against SARS-CoV-2 in two pediatric age groups, 5-11 and 12-17-year-old, while considering vaccine type, SARS-CoV-2 variant, and duration of protection. METHODS: A population-based test-negative control study was undertaken in Galicia, Spain. Children 5-11-year-old received the Comirnaty® (Pfizer, US) vaccine, while those aged 12-17-year-old received the Comirnaty® (Pfizer, US) or SpikeVax® (ModernaTX, Inc) vaccine. Participants were categorized into unvaccinated (0 doses or one dose with <14 days since vaccination), partially vaccinated (only one dose with ≥14 days, or two doses with <14 days after the second dose administration), and fully vaccinated (two doses with ≥14 days after the second injection). Adjusted odds ratios (OR) and their 95% confidence intervals (CI) were estimated using multiple logistic regression models. VE was calculated as (1-OR) * 100. Stratified and sensitivity analyses were performed. RESULTS: In the fully vaccinated 5-11-year-old children, VE against the Omicron variant was 44.1% (95% CI: 38.2%-49.4%). In the fully vaccinated 12-17-year-old individuals, VE was 83.4% (95% CI: 81.2%-85.3%) against Delta and 74.8% (95% CI: 58.5%-84.9%) against Omicron. Comirnaty® and SpikeVax® vaccines showed a similar magnitude of VE against Delta [Comirnaty® VE: 81.9% (95% CI: 79.3%-84.1%) and SpikeVax® VE: 85.3% (95% CI: 81.9%-88.1%)]. Comirnaty® (Pfizer, US; VE: 79.7%; 95% CI: 50.7%-92.4%) showed a slightly higher magnitude of protection against Omicron than SpikeVax® (ModernaTX, Inc), yet with an overlapping CI (VE: 74.3%; 95% CI: 56.6%-84.9%). VE was maintained in all age subgroups in both pediatric populations, but it declined over time. CONCLUSIONS: In Galicia, mRNA VE was moderate against SARS-CoV-2 infections in the 5-11-year-old populations, but high in older children. VE declined over time, suggesting a potential need for booster dose schedules.

Effectiveness of COVID-19 vaccine booster in the general population and in subjects with comorbidities. A population-based study in Spain.

BACKGROUND: Research on the effectiveness of COVID-19 booster-based vaccine schedule is ongoing and real-world data on vaccine effectiveness (VE) in comorbid patients are limited. We aimed to estimate booster dose VE against SARS-CoV-2 infection and COVID-19 severity in the general population and in comorbid patients. METHOD: A retrospective test-negative control study was undertaken in Galicia-Spain (December 2020-November 2021). VE and 95% confidence interval (CI) were estimated using multivariate logistic regression models. RESULTS: 1,512,415 (94.13%) negative and 94,334 (5.87%) positive SARS-CoV-2 test results were included. A booster dose of COVID-19 vaccine is associated with substantially higher protection against SARS-CoV-2 infection than vaccination without a booster [VEboosted = 87% (95%CI: 83%; 89%); VEnon-boosted = 66% (95%CI: 65%; 67%)]. The high VE was observed in all ages, but was more pronounced in subjects older than 65 years. VE against COVID-19 severity was analyzed in a mixed population of boosted and non-boosted individuals and considerable protection was obtained [VE: hospitalization = 72% (95%CI: 68%; 75%); intensive care unit administration = 83% (95%CI: 78%; 88%), in-hospital mortality = 66% (95%CI: 53%; 75%)]. Boosted comorbid patients are more protected against SARS-CoV-2 infection than those who were non-boosted. This was observed in a wide range of major diseases including cancer (81% versus 54%), chronic obstructive pulmonary disease (84% versus 61%), diabetes (84% versus 65%), hypertension (82% versus 65%) and obesity (91% versus 67%), among others. CONCLUSIONS: A booster dose of COVID-19 vaccine increases the protection against SARS-CoV-2 infection and COVID-19 severity in the general population and in comorbid patients.

Evaluation of BNT162b2 Vaccine Effectiveness in Galicia, Northwest Spain.

Investigating vaccine effectiveness (VE) in real-world conditions is crucial, especially its variation across different settings and populations. We undertook a test-negative control study in Galicia (Northwest Spain) to assess BNT162b2 effectiveness against acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as well as COVID-19 associated hospitalization, intensive care unit (ICU) admission and mortality. A total of 44,401 positive and 817,025 negative SARS-CoV-2 test results belonging to adults were included. Adjusted odds ratios of vaccination and their 95% confidence interval (CI) were estimated using multivariate logistic-regression models. BNT162b2 showed high effectiveness in reducing SARS-CoV-2 infections in all age categories, reaching maximum VE ≥ 14 days after administering the second dose [18-64 years: VE = 92.9% (95%CI: 90.2-95.1); 65-79 years: VE = 85.8% (95%CI: 77.3-91.9), and ≥80 years: VE = 91.4% (95%CI: 87.9-94.1)]. BNT162b2 also demonstrated effectiveness in preventing COVID-19 hospitalization for all age categories, with VE more pronounced for those aged ≥80 years [VE = 60.0% (95%CI: 49.4-68.3)]. Moreover, there was a considerable reduction in ICU admission [VE = 88.0% (95%CI: 74.6-95.8)] and mortality [VE = 38.0% (95%CI: 15.9-55.4)] in the overall population. BNT162b2 showed substantial protection against SARS-CoV-2 infections and COVID-19 severity. Our findings would prove useful for systematic reviews and meta-analysis on COVID-19 VE.

Hipertensión durante la gestación y su repercusión en algunos resultados perinatales en el Hospital Dr Agostinho Neto Guantánamo / Hypertension during pregnancy and its impact on some perinatal results in Dr Agostinho Neto Hospital, Guantanamo

La hipertensión durante la gestación se asocia con un incremento del riesgo de algunas complicaciones obstétricas y perinatales, contribuyendo al incremento de las tasas de morbimortalidad materna y perinatal. Objetivo: Determinar la influencia de la enfermedad hipertensiva gravídica en algunos resultados perinatales en nuestro medio, comparándolos con los encontrados en pacientes no hipertensas y sin otras afecciones asociadas. Método: Se realizó un estudio retrospectivo de casos y controles en el Hospital General Docente Dr Agostinho Neto, de Guatánamo durante el año 2006, con las gestantes hipertensas que parieron en ese año en el servicio de maternidad del centro. Se seleccionaron 97 embarazadas hipertensas y 194 no hipertensas mediante selección aleatoria simple para su comparación, se le determinó la edad, paridad, peso del neonato, APGAR al 5to minuto, complicaciones maternas, complicaciones neonatales, tipo de parto, mortalidad fetal y neonatal. Resultados: El bajo peso tuvo un OR = 3,28 (95 porciento IC = 1,20 9,17), la cesárea fue más frecuente en la hipertensas con un OR = 90,95 (95 porciento IC = 37,48 227,67), el APGAR bajo al 5to minuto fue superior entre las hipertensas con un OR = 11,39 (95,porciento IC = 4,50 30,07), el sangramiento postparto fue más frecuente en las hipertensas con un OR = 5,85 (95,porciento IC = 1,86 19,49), la sepsis neonatal, el CIUR y el Distress Respiratorio fueron estadísticamente más frecuentes entre las hipertensas. Conclusiones: La hipertensión arterial en el embarazo influye negativamente en una serie de parámetros perinatales en nuestro medio(AU)

Hypertension during pregnancy is associated with an increase of the risk of some obstetric and perinatal complications that contribute to the rise of the maternal and perinatal morbimortality rates. Objective: To determine the influence of the hypertensive gravid woman on some perinatal results on our environment, comparing them with those found in nonhypertensive patients and in patients with no other associated affections. Method: A retrospective case-control study was conducted among the pregnant women that gave birth at the maternity service of Dr Agostinho Neto General Teaching Hospital, in Guantánamo, during 2006. 97 hypertensive and 194 nonhypertensive pregnant women were chosen by simple randomized selection in order to compare them. Age, parity, infants birth weight, Apgar score at the 5th minute, maternal and neonatal complications, type of delivery, and fetal and neonatal mortality were determined. Results: Low birth weight had an OR = 3.28 (95 percent CI = 1.20 9.17), caesarean was more frequent in the hypertensive with an OR = 90.95 (95 percent CI = 37.48 227.67), low Apgar at the 5th minute was higher among the hypertensive with an OR = 11.39 (95 percent CI = 4.50 30.07), and the postpartum bleeding was more common in the hypertensive with an OR = 5.85 (95 percent CI = 1.86 19.49). Neonatal sepsis, IUGR and respiratory distress were statistically more frequent in the hypertensive. Conclusions: Arterial hypertension during pregnancy exert a negative influence on a series of perinatal parameters in our environment(AU)

Hipertensión durante la gestación y su repercusión en algunos resultados perinatales en el Hospital Dr Agostinho Neto Guantánamo / Hypertension during pregnancy and its impact on some perinatal results in Dr Agostinho Neto Hospital, Guantanamo

La hipertensión durante la gestación se asocia con un incremento del riesgo de algunas complicaciones obstétricas y perinatales, contribuyendo al incremento de las tasas de morbimortalidad materna y perinatal. Objetivo: Determinar la influencia de la enfermedad hipertensiva gravídica en algunos resultados perinatales en nuestro medio, comparándolos con los encontrados en pacientes no hipertensas y sin otras afecciones asociadas. Método: Se realizó un estudio retrospectivo de casos y controles en el Hospital General Docente Dr Agostinho Neto, de Guatánamo durante el año 2006, con las gestantes hipertensas que parieron en ese año en el servicio de maternidad del centro. Se seleccionaron 97 embarazadas hipertensas y 194 no hipertensas mediante selección aleatoria simple para su comparación, se le determinó la edad, paridad, peso del neonato, APGAR al 5to minuto, complicaciones maternas, complicaciones neonatales, tipo de parto, mortalidad fetal y neonatal. Resultados: El bajo peso tuvo un OR = 3,28 (95 porciento IC = 1,20 - 9,17), la cesárea fue más frecuente en la hipertensas con un OR = 90,95 (95 porciento IC = 37,48 - 227,67), el APGAR bajo al 5to minuto fue superior entre las hipertensas con un OR = 11,39 (95,porciento IC = 4,50 - 30,07), el sangramiento postparto fue más frecuente en las hipertensas con un OR = 5,85 (95,porciento IC = 1,86 - 19,49), la sepsis neonatal, el CIUR y el Distress Respiratorio fueron estadísticamente más frecuentes entre las hipertensas. Conclusiones: La hipertensión arterial en el embarazo influye negativamente en una serie de parámetros perinatales en nuestro medio.

Hypertension during pregnancy is associated with an increase of the risk of some obstetric and perinatal complications that contribute to the rise of the maternal and perinatal morbimortality rates. Objective: To determine the influence of the hypertensive gravid woman on some perinatal results on our environment, comparing them with those found in nonhypertensive patients and in patients with no other associated affections. Method: A retrospective case-control study was conducted among the pregnant women that gave birth at the maternity service of Dr Agostinho Neto General Teaching Hospital, in Guantánamo, during 2006. 97 hypertensive and 194 nonhypertensive pregnant women were chosen by simple randomized selection in order to compare them. Age, parity, infant's birth weight, Apgar score at the 5th minute, maternal and neonatal complications, type of delivery, and fetal and neonatal mortality were determined. Results: Low birth weight had an OR = 3.28 (95 percent CI = 1.20 - 9.17), caesarean was more frequent in the hypertensive with an OR = 90.95 (95 percent CI = 37.48 - 227.67), low Apgar at the 5th minute was higher among the hypertensive with an OR = 11.39 (95 percent CI = 4.50 - 30.07), and the postpartum bleeding was more common in the hypertensive with an OR = 5.85 (95 percent CI = 1.86 - 19.49). Neonatal sepsis, IUGR and respiratory distress were statistically more frequent in the hypertensive. Conclusions: Arterial hypertension during pregnancy exert a negative influence on a series of perinatal parameters in our environment.

Influencia de la rotura prematura de membranas en algunos resultados perinatales. Hospital General Docente Dr Agostinho Neto / Influence of premature rupture of membrane on some perinatal results: Dr Agostinho Neto General Teaching Hospital

La rotura prematura de membranas (RPM) se asocia con algunos eventos obstétricos y perinatales desfavorables. Por ello el objetivo trazado fue determinar la influencia de la RPM sobre algunos parámetros perinatales, para lo cual se realizó un estudio retrospectivo, analítico, de casos y controles en el Hospital General Docente Dr Agostinho Neto de Guantánamo, en el período enero de 2005 a diciembre de 2006. Se seleccionaron de forma aleatoria 952 gestantes con RPM y 952 gestantes sin RPM, se determinaron variables como: peso al nacer, Apgar al 5to minuto, vía del parto, morbilidad materna y neonatal, mortalidad fetal y neonatal. Se constató que las gestantes con RPM tuvieron un 18 por ciento de bajo peso contra un 12,7 por ciento en las pacientes sin RPM, Odds Ratio (OR) = 1,50 (95 por ciento IC = 1,16-1,95); el Apgar bajo se presentó en el 84 por ciento entre las primeras en relación con el total de deprimidos contra sólo el 16,2 por ciento entre las segundas, OR = 5,32 (95 por ciento IC = 1,93 15,83); la endometritis fue la complicación materna más frecuente con un 36,2por ciento del total de complicaciones entre las pacientes con RPM y 9,5 por ciento entre las pacientes sin RPM, OR = 8,64 (95 por ciento, IC 1,92-54,22); la sepsis neonatal, el síndrome de dificultad respiratoria y la hipoxia perinatal, fueron las complicaciones neonatales más frecuentes, OR = 1,66 (95 por ciento 1,17-2,36), 8,88 (95 por ciento 2,56-36,92) y 5,06 (95 por ciento 1,38-22,05) respectivamente; las muertes fetales presentaron un OR = 1,71 (95 por ciento 0,82-3,61) y las muertes neonatales OR= 2,00 (95 por ciento 0,14-55,8) comparando los dos grupos de estudio (AU)

Premature rupture of membrane (PROM) is associated with some unfavorable obstetric and perinatal events. Thats why, the aim of this paper was to determine the influence of PROM on some perinatal parameters. To this end, a retrospective and analytical case- control study was conducted at Dr Agostinho Neto General Teaching Hospital, in Guantánamo, from January 2005 to December 2006. 952 pregnant women with PROM and the same number of expectants without it were selected at random. Variables such as birthweight, Apgar score at 5 minutes, delivery route, maternal and neonatal morbidity, and fetal and neonatal mortality, were determined. It was proved that pregnant women with PROM had 18 percent of low birth weight vs. 12.7 percent among those without it, Odds Ratio (OR) = 1.50 (95 percent CI= 1.16 1.95); low Apgar was observed in 84 percent of the first group in relation to the total of the depressed, whereas it was just 16.2 percent in the second group OR = 5.32 (95 percent CI = 1.93 15.83); endometritis was the most common maternal complication, with 36.2 percent of the total of complications in patients with PROM, and 9.5 percent in those with no PROM, OR = 8.64 (95 percent, CI 1.92 54.22). Neonatal sepsis, the respiratory distress syndrome and perinatal hypoxia were the most frequent neonatal complications, OR = 1.66 (95 percent 1.17- 2.36), 8.88 (95 percent 2.56 36.92) y 5.06 (95 percent 1.38 22.05), respectively. Fetal deaths presented an OR = 1.71 (95 percent 0.82 3.61), whereas neonatal deaths had an OR = 2.00 (95 percent 0.14 55.8), on comparing the two study group(AU)

Influencia de la rotura prematura de membranas en algunos resultados perinatales. Hospital General Docente Dr Agostinho Neto / Influence of premature rupture of membrane on some perinatal results: Dr Agostinho Neto General Teaching Hospital

La rotura prematura de membranas (RPM) se asocia con algunos eventos obstétricos y perinatales desfavorables. Por ello el objetivo trazado fue determinar la influencia de la RPM sobre algunos parámetros perinatales, para lo cual se realizó un estudio retrospectivo, analítico, de casos y controles en el Hospital General Docente Dr Agostinho Neto de Guantánamo, en el período enero de 2005 a diciembre de 2006. Se seleccionaron de forma aleatoria 952 gestantes con RPM y 952 gestantes sin RPM, se determinaron variables como: peso al nacer, Apgar al 5to minuto, vía del parto, morbilidad materna y neonatal, mortalidad fetal y neonatal. Se constató que las gestantes con RPM tuvieron un 18 por ciento de bajo peso contra un 12,7 por ciento en las pacientes sin RPM, Odds Ratio (OR) = 1,50 (95 por ciento IC = 1,16-1,95); el Apgar bajo se presentó en el 84 por ciento entre las primeras en relación con el total de deprimidos contra sólo el 16,2 por ciento entre las segundas, OR = 5,32 (95 por ciento IC = 1,93 - 15,83); la endometritis fue la complicación materna mßs frecuente con un 36,2por ciento del total de complicaciones entre las pacientes con RPM y 9,5 por ciento entre las pacientes sin RPM, OR = 8,64 (95 por ciento, IC 1,92-54,22); la sepsis neonatal, el síndrome de dificultad respiratoria y la hipoxia perinatal, fueron las complicaciones neonatales más frecuentes, OR = 1,66 (95 por ciento 1,17-2,36), 8,88 (95 por ciento 2,56-36,92) y 5,06 (95 por ciento 1,38-22,05) respectivamente; las muertes fetales presentaron un OR = 1,71 (95 por ciento 0,82-3,61) y las muertes neonatales OR= 2,00 (95 por ciento 0,14-55,8) comparando los dos grupos de estudio.

Premature rupture of membrane (PROM) is associated with some unfavorable obstetric and perinatal events. That's why, the aim of this paper was to determine the influence of PROM on some perinatal parameters. To this end, a retrospective and analytical case- control study was conducted at Dr Agostinho Neto General Teaching Hospital, in Guantánamo, from January 2005 to December 2006. 952 pregnant women with PROM and the same number of expectants without it were selected at random. Variables such as birthweight, Apgar score at 5 minutes, delivery route, maternal and neonatal morbidity, and fetal and neonatal mortality, were determined. It was proved that pregnant women with PROM had 18 percent of low birth weight vs. 12.7 percent among those without it, Odds Ratio (OR) = 1.50 (95 percent CI= 1.16 - 1.95); low Apgar was observed in 84 percent of the first group in relation to the total of the depressed, whereas it was just 16.2 percent in the second group OR = 5.32 (95 percent CI = 1.93 - 15.83); endometritis was the most common maternal complication, with 36.2 percent of the total of complications in patients with PROM, and 9.5 percent in those with no PROM, OR = 8.64 (95 percent, CI 1.92 - 54.22). Neonatal sepsis, the respiratory distress syndrome and perinatal hypoxia were the most frequent neonatal complications, OR = 1.66 (95 percent 1.17- 2.36), 8.88 (95 percent 2.56 - 36.92) y 5.06 (95 percent 1.38 - 22.05), respectively. Fetal deaths presented an OR = 1.71 (95 percent 0.82 - 3.61), whereas neonatal deaths had an OR = 2.00 (95 percent 0.14 - 55.8), on comparing the two study group.