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Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial.

ABSTRACT: There are limited data about the effect of maternal influenza infection on fetuses and newborns. We performed a secondary analysis of data from the Mother's Gift project, a randomized study designed to test the effectiveness of inactivated influenza and pneumococcal vaccines during pregnancy.In the Mother's Gift project, 340 pregnant women in Bangladesh received either inactivated influenza vaccine or 23-valent pneumococcal polysaccharide vaccine (control). This study was performed from August 2004 through December 2005. We performed a secondary analysis of outcomes following maternal influenza immunization during two periods: when influenza virus was not circulating (September 2004 through January 2005) and when influenza virus was circulating (February through October 2005). We assessed gestational age, mean birth weight and the proportion of infants who were small for gestational age.During the period with no circulating influenza virus, there were no differences in the incidence of respiratory illness with fever per 100 person-months among mothers and infants in the two groups (influenza vaccine: 3.9; control: 4.0; p > 0.9). The proportion of infants who were small for gestational age and the mean birth weight were similar between groups (small for gestational age: influenza vaccine 29.1%, control 34.3%; mean birth weight: influenza vaccine 3083 g, control 3053 g). During the period with circulating influenza virus, there was a substantial reduction in the incidence per 100 person-months of respiratory illness with fever among the mothers and infants who had received the influenza vaccine (influenza vaccine: 3.7; control: 7.2; p = 0.0003). During this period, the proportion of infants who were small for gestational age was lower in the influenza vaccine group than in the control group (25.9% v. 44.8%; p = 0.03). The mean birth weight was higher among infants whose mothers received the influenza vaccine than among those who received the control vaccine during this period (3178 g v. 2978 g; p = 0.02).During the period with circulating influenza virus, maternal immunization during pregnancy was associated with a lower proportion of infants who were small for gestational age and an increase in mean birth weight. These data need confirmation but suggest that prevention of influenza infection in pregnancy can influence intrauterine growth.ClinicalTrials.gov: NCT 00142389.

SUBMITTER: Steinhoff MC

PROVIDER: S-EPMC3314035 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature

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Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial.

Steinhoff Mark C MC Omer Saad B SB Roy Eliza E El Arifeen Shams S Raqib Rubhana R Dodd Caitlin C Breiman Robert F RF Zaman K K

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20120221 6

<h4>Background</h4>There are limited data about the effect of maternal influenza infection on fetuses and newborns. We performed a secondary analysis of data from the Mother's Gift project, a randomized study designed to test the effectiveness of inactivated influenza and pneumococcal vaccines during pregnancy.<h4>Methods</h4>In the Mother's Gift project, 340 pregnant women in Bangladesh received either inactivated influenza vaccine or 23-valent pneumococcal polysaccharide vaccine (control). Thi ...[more]

PMID: 22353593

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Project description:BackgroundWomen are encouraged to be physically active during pregnancy. Despite available evidence supporting antenatal physical activity to bring health benefits for both the mother and child, the most effective way to prevent some maternal and fetal outcomes is still unclear. The purpose of this study was to evaluate the efficacy of an exercise intervention to prevent negative maternal and newborn health outcomes.MethodsA randomized controlled trial (RCT) nested into the 2015 Pelotas (Brazil) Birth Cohort Study was carried-out with 639 healthy pregnant women, 213 in the intervention group (IG) and 426 in the control (CG) group. An exercise-based intervention was conducted three times/week for 16 weeks from 16-20 to 32-36 weeks' gestation. The main outcomes were preterm birth and pre-eclampsia. Gestational age was calculated based on several parameters, including routine ultrassounds and/or last menstrual period and categorized as < 37 weeks and ≥ 37 weeks for evaluation of preterm birth. Pre-eclampsia was self-reported. Secondary outcomes were gestational weight gain, gestational diabetes, birth weight, infant length, and head circumference. Analyses were performed by intention-to-treat (ITT) and per protocol (70% of the 48 planned exercise sessions). Odds ratio were derived using unconditional logistic regression.ResultsThe IG and CG did not differ at baseline regarding their mean age (27.2 years ± 5.3 vs. 27.1 years ± 5.7) and mean pre-pregnancy body mass index (25.1 ± 3.9 vs. 25.2 ± 4.1 kg/m2). The mean adherence to the exercise intervention was 27 ± 17.2 sessions (out of a potential 48) with 40.4% attending > = 70% of the recommended exercise sessions. A total of 594 participants (IG:198; CG: 396) were included in the ITT and 479 (IG: 83; CG: 396) were included in the per protocol analyses. There were no significant differences in the incidence of preterm birth and pre-eclampsia between groups in the ITT and per protocol analysis. There were also no differences between the two groups in mean gestational weight gain, gestational diabetes, birth weight, infant length, and head circumference.ConclusionsWhile the RCT did not support the benefits of exercise performed during pregnancy on preeclampsia and preterm birth, the exercise program also did not present adverse impacts on newborn health. Our findings may contribute to promote intervention strategies that motivate health providers to encourage pregnant women to be more physically active.Trial registrationClinicaltrials.gov identifier: NCT02148965 , registered on 22 May 2014.

Project description:BACKGROUND:Improved immunization rates have reduced the incidence of vaccine-preventable diseases (VPDs) in advanced nations. Japan's unique vaccination system classifies vaccines into routine vaccines ostensibly required under the Preventive Vaccination Law and recommended but optional vaccines, although all vaccines are in fact voluntary. In Japan, low immunization rates, particularly for optional vaccines, have resulted in high rates of sequelae and death. The decision as to whether a child will receive a vaccine depends on the parents, who must obtain information, make inquiries, and make the required payment, the last of which is a major barrier. This randomized, controlled trial was conducted to evaluate the effectiveness of an immunization education program designed to meet mothers' needs. METHODS:This randomized controlled trial assigned pregnant women to intervention or control groups. The intervention was individual education sessions involving the children's fathers in shared decision-making on whether or not to immunize their child. A survey was conducted before and after the intervention. Data were analyzed using the intention-to-treat principle. RESULTS:Of 225 pregnant women, 175 (78%) participated and 171 replied to the post-survey. At age 3?months, intervention infants had higher self-reported immunization rates for hepatitis B virus vaccine (76% vs. 49%; P?<?0.001) and rotavirus vaccine (84% vs. 68%; P?=?0.019) than control group infants. The percentage of parents intending to vaccinate their infants was higher in the intervention group (77% vs. 52%; P?<?0.01). Improvements in scores for basic knowledge (mean [SD]: 5.5 [3.6] vs. 3.0 [3.8], range: 10-30; P?<?0.001), advanced knowledge (mean [SD]: 5.1 [2.4] vs. 2.8 [2.5], range: 5-15; P?<?0.001), and health literacy regarding immunization (mean [SD]: 0.5 [0.8] vs. 0.2 [0.6], range: 1-5; P?<?0.01) were higher in the intervention group. The rate of decision making by both parents (68% vs. 52%; P?<?0.05) was higher in the intervention group. CONCLUSIONS:Our findings confirmed the program's effectiveness. The intervention improved immunization rates, the percentage of parents intending to vaccinate their infants and knowledge scores. Interventions which directly and indirectly involved fathers in shared decision-making on whether to immunize their child were effective, as were individualized interventions that provided parents with access to up-to-date information. TRIAL REGISTRATION:UMIN000012575 . Registered 14 December 2013 (The study was prospectively registered).

Project description:BackgroundHealthcare personnel influenza immunization rates remain sub-optimal. Following multiple studies and expert consultations, the "Successful Influenza Immunization Programs for Healthcare Personnel: A Guide for Program Planners" was produced. This trial assessed the impact of the Guide with facilitation in improving healthcare personnel influenza immunization rates in Canadian healthcare organizations.MethodsA sample of 26 healthcare organizations across six Canadian provinces (ON, MB, NS, BC, SK, NL) was randomized to Intervention (n=13) or Control groups (n=13). Baseline influenza immunization rates were obtained for 2008-2009; the study groups were followed over two subsequent influenza seasons. The Intervention group received the Guide, facilitation support through workshops for managers and ongoing support. The Control groups conducted programs as usual. The Groups were compared using their reported influenza healthcare personnel influenza immunization rates and scores from a program assessment questionnaire.FindingsTwenty-six organizations agreed to participate. 35% (9/26) of sites were acute care hospitals, 19% (5/26) continuing care, long-term care organizations or nursing homes, and 46% (12/26) were mixed acute care hospitals and long-term care or regional health authorities. The median rate of influenza immunization among healthcare personnel for the Intervention group was 43%, 44%, and 51% at three points in time respectively, and in theControl group62%, 57%, and 55% respectively. No significant differences were observed between the groups at the three points in time. However, there was a 7% increase in the median rates between the Baseline Year and Year Two in the Intervention group, and a 6% decrease in the CONTROL GROUP over the same time period, which was statistically significant (0.071 versus -0.058, p < 0.001).InterpretationThis pragmatic randomized trial of the Guide with facilitation of its implementation improved healthcare personnel immunization rates, but these rates continued to be sub-optimal and below rates achievable in programs requiring personnel to be immunized.Trial registrationClinicalTrials.gov NCT01207518.

Project description:BackgroundBeyond perinatal folic acid supplementation, the need for additional prenatal prophylaxis of iron with or without other micronutrients remains unclear. We aim to investigate the maternal and infant health effects of iron plus folic acid and multiple micronutrient supplements vs folic acid alone when provided to pregnant women with no or mild anemia.MethodsIn this randomized double-blind controlled trial, 18,775 nulliparous pregnant women with mild or no anemia were enrolled from 5 counties of northern China from May 2006 through April 2009. Women were randomly assigned to daily folic acid (400 μg) (control), folic acid-iron (30 mg), or folic acid, iron, and 13 additional vitamins and minerals provided before 20 weeks gestation to delivery. Primary outcome was perinatal mortality. Secondary outcomes included neonatal and infant mortality, preterm delivery, birth weight, birth length, gestational duration, and maternal hemoglobin concentration and anemia.ResultsA total of 92.7% of women consumed 80% to 100% of supplements as instructed. On average, women consumed 177 supplements. Compared with daily prenatal folic acid, supplementation with iron-folic acid with or without other micronutrients did not affect the rate of perinatal mortality (8.8, 8.7, and 8.3, respectively) per 1000 births, and relative risks (RRs) were 1.00 (95% CI, 0.68-1.46; P = .99) and 0.94 (95% CI, 0.64-1.39; P = .76), respectively. Risk of other adverse maternal and infant outcomes also did not differ, except that RRs for third-trimester maternal anemia were 0.72 (95% CI, 0.63-0.83; P < .001) and 0.71 (95% CI, 0.62-0.82; P < .001), respectively.ConclusionPrenatal iron-folic acid and other micronutrient supplements provided to Chinese women with no or mild anemia prevented later pregnancy anemia beyond any benefit conferred by folic acid alone but did not affect perinatal mortality or other infant outcomes.Trial registrationclinicaltrials.gov Identifier: NCT00133744.

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Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial.

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Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial.

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