scholarly journals Investigating N-3 Fatty Acids to prevent Neonatal Tobacco-related outcomeS (INFANTS): study protocol for a double-blind, randomized, placebo-controlled parallel clinical trial of n-3 polyunsaturated fatty acids in pregnant smokers

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Harvey J. Murff ◽  
Robert A. Greevy ◽  
Reesha S. Sanghani ◽  
Katherine E. Hartmann ◽  
Tina V. Hartert ◽  
...  

Abstract Background Tobacco use during pregnancy is the most important modifiable risk factor associated with adverse pregnancy outcomes, increasing the risk of preterm birth, intrauterine growth restriction and sudden infant death syndrome. Fewer than half of pregnant smokers can quit on their own. Identifying safe and effective therapies to prevent tobacco-related adverse pregnancy outcomes and/or increase smoking cessation in pregnant women would have a substantial public health impact. Cigarette smoking is associated with a relative deficiency in circulating n-3 long-chain polyunsaturated fatty acid (n-3 LCPUFA) levels. A recent analysis found that smokers taking n-3 LCPUFAs during pregnancy had a reduction in preterm labor risk when compared to non-smokers. Studies have shown that supplemental n-3 LCPUFAs may also reduce nicotine cravings and daily cigarette use. Thus, smokers may benefit from supplemental n-3 LCPUFAs by lowering the risk of preterm labor and/or increased smoking cessation. To address important remaining knowledge gaps, we propose the Investigating N-3 Fatty Acids to prevent Neonatal Tobacco related outcomeS (INFANTS). Methods The INFANTS study is a multicenter, randomized, double-blind, placebo-controlled study that will randomize 400 pregnant smokers to either supplemental n-3 LCPUFAs or placebo. Participants will be enrolled between 12 and 24 weeks’ gestation and followed until 6 weeks after delivery. We will recruit from clinical centers throughout Middle Tennessee. We will assess smoking behavior after 12 weeks of supplementation using self-report and validated biomarkers of tobacco exposure. We will measure response to supplementation using biological markers of n-3 LCPUFA status. Our primary endpoint will be preterm labor as reflected by gestational age at delivery. Our secondary endpoint will be change from baseline in cigarettes per day at 12 weeks. Discussion This study tests the hypothesis that smoking-induced n-3 LCPUFA deficiencies contribute to tobacco-related adverse pregnancy outcomes and that supplementation of n-3 LCPUFAs in pregnant smokers may prevent these complications. If our study demonstrates that supplemental n-3 LCPUFAs are effective at reducing the risk of tobacco-related adverse neonatal outcomes and/or reducing tobacco use during pregnancy, our results could have an immediate and major impact on pregnancy care and neonatal outcomes. Trial registration ClinicalTrials.gov NCT04417595. Registered on April 21, 2020

2010 ◽  
Vol 89 (4) ◽  
pp. 454-464 ◽  
Author(s):  
Lucinda J. England ◽  
Shin Y. Kim ◽  
Scott L Tomar ◽  
Cecily S Ray ◽  
Prakash C. Gupta ◽  
...  

2021 ◽  
Vol 11 (4) ◽  
pp. 170-181
Author(s):  
Bandana Dobhal ◽  
Karuna . ◽  
Sana Manzoor Ahmed

Background: Maternal smoking is known to pose risks to both baby and mother affecting aspects from fertility and pregnancy outcome to fetal and child development. Objective: To study the prevalence of maternal smoking globally and its adverse pregnancy outcomes. Materials and methods: Health sciences electronic databases PubMed and Google Scholar were searched for studies published between 2006 to March 2020. Keywords used for the search were (“tobacco”), ("maternal smoking"), ("effects of maternal smoking") and (“globally”). A total of 29 articles were included in the review based on the eligibility criteria. Statistical software SPSS-V.23 was used for the statistical application. Result: A total of 29 studies met the inclusion criteria with a total of 11,34,769 women, age ranged from 12-45 years and above. Maternal smoking was reported by 22.26% women. Those women who reside in rural areas, illiterate, homemaker, from low economic status and whose husband smoke have higher maternal smoking prevalence and its adverse pregnancy outcomes were reported as 23.27% low maternal weight, 62.46% anaemic mother, 8.76% low birth weight, 12.86% preterm birth, 79% low birth length and 15.77% obesity among children. Conclusion: Maternal tobacco use in any form increases risk of ill effects on mother and child health. Tobacco cessation during pregnancy is necessary to reduce morbidity and mortality related to tobacco use. Key words: Maternal smoking, cigarette, smokeless tobacco, prevalence, effects of maternal smoking, Globally.


2021 ◽  
Vol 9 (B) ◽  
pp. 1681-1685
Author(s):  
Irena Andonova ◽  
Vasil Iliev

Bacterial vaginosis and periodontal diseases share very similar pathogenesis. Each of these diseases occurs when healthy microbiome changes to predominately anaerobic bacterial flora. Bacterial vaginosis is proven factor for adverse pregnancy outcomes. In recent years it has been hypothesized that infection from distant sites of the fetoplacental unit may also elicit an inflammatory response in utero. Aim: The study is designed to determine whether the presence of specific oral anaerobic bacteria in subgingival sulcus of mother increase the risk of adverse obstetric outcomes. Material and Methods: Case-control study.  Control group: 50 patients who gave birth to neonate whit normal birth weight at term. Group cases: I group - 40 pregnant women who were hospitalized with signs of preterm labor. II - 20 pregnant women, who have an ultrasound diagnosis of fetal growth retardation. Sub-gingival microbiological paper-point swab was taken in all patients. Results: The total number of isolated oral anaerobic bacteria was statistically significantly higher in the cases group compared to control group p <0.01. In our study, pregnant women who tested positive for Porphyrmonas gingivalis for 6.65 times were more likely to have preterm labor compare with pregnant women with negative oral swabs (95.0% CI: 1.38-32.11 / p <0.05), and for 2,79 times more likely to have fetus with intrauterine growth restriction (95.0% CI: 1.10-7.91 / p <0.05 Conclusions: The study confirmed the hypothesis of a statistically significant association between oral anaerobic infection and adverse pregnancy outcomes. In the future, more studies are needed to investigate the role of the microbial load, maternal immune response, pathophysiological pathway that leads to negative pregnancy outcome.  


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Wei Zheng ◽  
Wenyu Huang ◽  
Cheng Liu ◽  
Qi Yan ◽  
Li Zhang ◽  
...  

Abstract Background Gestational diabetes mellitus (GDM) and excessive body weight are two key risk factors for adverse perinatal outcomes. However, it is not clear whether restricted gestational weight gain (GWG) is favorable to reduce the risk for adverse pregnancy and neonatal outcomes in women with GDM. Therefore, this study aimed to assess the association of GWG after an oral glucose tolerance test with maternal and neonatal outcomes. Methods This prospective cohort study assessed the association of GWG after an oral glucose tolerance test (OGTT) with pregnancy and neonatal outcomes in 3126 women with GDM, adjusted for age, pre-pregnancy body mass index, height, gravidity, parity, adverse history of pregnancy, GWG before OGTT, blood glucose level at OGTT and late pregnancy. The outcomes included the prevalence of pregnancy-induced hypertension (PIH) and preeclampsia, large for gestational age (LGA), small for gestational age, macrosomia, low birth weight, preterm birth, and birth by cesarean section. GDM was diagnosed according to the criteria established by the International Association of Diabetes and Pregnancy Study Groups. Results GWG after OGTT was positively associated with risk for overall adverse pregnancy outcomes (adjusted odds ratio [aOR] = 1.72, 95% confidence interval [CI] = 1.50–1.97), LGA (aOR = 1.29, 95%CI = 1.13–1.47), macrosomia (aOR = 1.24, 95%CI = 1.06–1.46) and birth by cesarean section (aOR = 1.91, 95%CI = 1.67–2.19) in women with GDM. Further analyses revealed that a combination of excessive GWG before OGTT and after OGTT increased the risk of PIH and preeclampsia, LGA, macrosomia, and birth by cesarean section compared with adequate GWG throughout pregnancy. In contrast, GWG below the Institute of Medicine guideline after OGTT did not increase the risk of adverse perinatal outcomes despite GWG before OGTT. Conclusion Excessive GWG after OGTT was associated with an elevated risk of adverse pregnancy outcomes, while insufficient GWG after OGTT did not increase the risk of LBW. Restricting GWG after diagnosis of GDM in women with excessive GWG in the first half of pregnancy may be beneficial to prevent PIH and preeclampsia, LGA, macrosomia, and birth by cesarean section.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1959-1959
Author(s):  
Irina Murakhovskaya ◽  
Jesus Anampa ◽  
Hieu Nguyen ◽  
Veronica Sadler ◽  
Henny H. Billett

Abstract Introduction: Autoimmune hemolytic anemia (AIHA) is a rare condition that can cause potentially serious complications in pregnant women and newborns. With the lack of prospective trials, physicians often have to make treatment decisions for this vulnerable population based on scarce literature with poor evidence. We sought to summarize existing literature and analyze maternal and neonatal outcomes in pregnancy-associated AIHA (p-AIHA). Methods: Cases of AIHA in pregnancy were collected using MEDLINE/PubMed and Google Scholar literature search using terms "autoimmune hemolytic anemia" and "pregnancy". Bibliography of each article was hand-searched for additional reports. Only publications in English were included. Cases of preexisting AIHA, autoimmune disease associated AIHA, non-immune hemolysis, and cases where direct antiglobulin testing (DAT) was not performed, were excluded. Laboratory, obstetric, neonatal and treatment data were collected. Data were analyzed using descriptive statistics. We used Wilcoxon rank sum test for continuous variables and Fisher's exact test for categorical variables. When missing data were encountered, we reported a valid number of analyzed patients in parentheses. Results: We identified 87 cases of p-AIHA from case reports, case series, abstracts and posters. Final analysis included 51 individual women. Median age at p-AIHA presentation was 28 years. Presentation was less common in the first pregnancy (34%); most cases presented in the second or third trimester (83.3%).Median nadir hemoglobin (Hb), lactate dehydrogenase, total bilirubin and peak reticulocyte count were 5.8 g/dL, 457 U/L, 2.2, and 13.6%, respectively. DAT negative hemolysis was reported in 41% of cases (Table 1). DAT positivity was not associated with pregnancy trimester, hemolysis severity, response to steroids, AIHA recurrence, adverse pregnancy outcomes, or hemolysis in newborn. There was a trend for longer duration of hemolysis postpartum in women with positive DAT compared to negative DAT (10 vs 2 weeks, p = 0.08). Median duration of hemolysis postpartum was 6 weeks (n=27, range 0-96 weeks). Two thirds of women were treated with steroids with hemoglobin response of 88.9% (n=27). There was no association between steroid use and duration of hemolysis postpartum. Blood transfusion was administered in 27 out of 33 women, with a median number of units transfused 5. Recurrent p-AIHA was seen in 40% (12/30) of women; there was no difference in nadir Hb levels for those with recurrent p-AIHA vs. not recurrent (6.8 vs 5.2 g/dL, p=0.11). Pregnancy resulted in term delivery in 61.9%, preterm delivery in 23.8%, and stillbirth in 9.5% (n=42). Adverse pregnancy outcomes, which included preterm labor and stillbirth, were reported in 50% of women who presented in the first or second trimester compared to 16% who presented in the third trimester (p=0.049, Table 2).Women with adverse pregnancy outcomes had significantly lower median nadir hemoglobin compared to women without adverse pregnancy outcomes (4.3 and 6.2 p = 0.0078) and were more likely to receive transfusion (73% and 56%, p= 0.071). Hemolysis at birth was reported in 59% (n=22) of newborns with available data with 13 neonates (38%) requiring transfusion support . Use of steroids had no effect on presence of hemolysis in the newborn. Conclusions: We present the largest cohort of p-AIHA described in the literature. Our study reports that p-AIHA is uncommon in primigravidas and typically presents later in pregnancy. Presentation in first or second trimester in pregnancy and lower Hb nadir were significantly associated with adverse pregnancy outcomes. Steroids and blood transfusions were needed in most patients, and hemolysis persisted on average for 6 weeks postpartum. There was a high frequency of Coombs negativity which was associated with shorter duration of postpartum hemolysis. Preterm labor and stillbirth were observed in 33.3% of pregnancies. The incidence of hemolysis in newborns from p-AIHA mothers is very high and is often clinically significant. Recurrence in subsequent pregnancy is common but has similar Hb nadir as non-recurrent cases. This study provides insights into the clinical course of pregnancy and neonatal outcomes in p-AIHA. Our findings may help guide management of this rare condition. A prospective study of patients with p-AIHA is needed to determine optimal therapy to reduce antepartum and neonatal complications. Figure 1 Figure 1. Disclosures Murakhovskaya: Alexion, Rigel, Bioverativ/Sanofi, Momenta, Annexion, Incyte: Research Funding; Bioverativ/Sanofi, Momenta, Apellis, Novartis: Consultancy; Cardiff Oncology, Trillium Therapeutics: Current holder of individual stocks in a privately-held company.


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