Pregnancy Complications In Pregnant Women Research Articles

Effects of HBsAg carriers on pregnancy complications in pregnant women: a retrospective cohort study.

Hepatitis B virus (HBV) infection is a major health threat worldwide, especially in developing countries. We aimed to investigate the impact of hepatitis B carrier on pregnancy complications in pregnant women, in China. This retrospective cohort study was conducted by using data from the EHR system of Longhua District People's Hospital in Shenzhen, China, from January 2018 to June 2022. Binary logistic regression was used to evaluate the relationship between HBsAg carrier status and pregnancy complications and pregnancy outcomes. The study included 2095 HBsAg carriers (exposed group) and 23,019 normal pregnant women (unexposed group). Pregnant women in the exposed group were older than the pregnant women in the unexposed group (29 (27,32) vs. 29 (26,32), p < 0.001). In addition, the incidence of some adverse pregnancy complications in the exposure group was lower than that in the unexposed group, including hypothyroidism of pregnancy (adjusted odds ratio [aOR], 0.779; 95% confidence interval [CI], 0.617-0.984; p = 0.036), hyperthyroidism of pregnancy (aOR, 0.388; 95% CI, 0.159-0.984; p = 0.038), pregnancy induced hypertension (aOR, 0.699; 95% CI, 0.551-0.887; p = 0.003), antepartum hemorrhage (aOR, 0.294; 95% CI, 0.093-0.929; p = 0.037). However, compared with the unexposed group, the exposed group had a higher risk of lower birth weight (aOR, 1.12; 95% CI, 1.02-1.23; p = 0.018) and intrahepatic cholestasis of pregnancy (aOR, 2.888, 95% CI, 2.207-3.780; p < 0.001). The prevalence rate of HBsAg carriers in pregnant women in Longhua District of Shenzhen was 8.34%. Compared with normal pregnant women, HBsAg carriers have a higher risk of ICP, a lower risk of gestational hypothyroidism and PIH, and a lower birth weight of their infants.

Potential genetic biomarkers predict adverse pregnancy outcome during early and mid-pregnancy in women with systemic lupus erythematosus.

Effectively predicting the risk of adverse pregnancy outcome (APO) in women with systemic lupus erythematosus (SLE) during early and mid-pregnancy is a challenge. This study was aimed to identify potential markers for early prediction of APO risk in women with SLE. The GSE108497 gene expression dataset containing 120 samples (36 patients, 84 controls) was downloaded from the Gene Expression Omnibus database. Weighted gene co-expression network analysis (WGCNA) was performed, and differentially expressed genes (DEGs) were screened to define candidate APO marker genes. Next, three individual machine learning methods, random forest, support vector machine-recursive feature elimination, and least absolute shrinkage and selection operator, were combined to identify feature genes from the APO candidate set. The predictive performance of feature genes for APO risk was assessed using area under the receiver operating characteristic curve (AUC) and calibration curves. The potential functions of these feature genes were finally analyzed by conventional gene set enrichment analysis and CIBERSORT algorithm analysis. We identified 321 significantly up-regulated genes and 307 down-regulated genes between patients and controls, along with 181 potential functionally associated genes in the WGCNA analysis. By integrating these results, we revealed 70 APO candidate genes. Three feature genes, SEZ6, NRAD1, and LPAR4, were identified by machine learning methods. Of these, SEZ6 (AUC = 0.753) showed the highest in-sample predictive performance for APO risk in pregnant women with SLE, followed by NRAD1 (AUC = 0.694) and LPAR4 (AUC = 0.654). After performing leave-one-out cross validation, corresponding AUCs for SEZ6, NRAD1, and LPAR4 were 0.731, 0.668, and 0.626, respectively. Moreover, CIBERSORT analysis showed a positive correlation between regulatory T cell levels and SEZ6 expression (P < 0.01), along with a negative correlation between M2 macrophages levels and LPAR4 expression (P < 0.01). Our preliminary findings suggested that SEZ6, NRAD1, and LPAR4 might represent the useful genetic biomarkers for predicting APO risk during early and mid-pregnancy in women with SLE, and enhanced our understanding of the origins of pregnancy complications in pregnant women with SLE. However, further validation was required.

S1449 Prior Bariatric Surgery and Labor/Delivery and Pregnancy Complications

S1449 Prior Bariatric Surgery and Labor/Delivery and Pregnancy Complications

THE FEATURES OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE INFLUENCE ON THE PREGNANCY COMPLICATIONS DEVELOPMENT

&#x0D; &#x0D; &#x0D; &#x0D; In recent years, the prevalence of chronic obstructive pulmonary disease (COPD) has been increasingly observed among women, which is one of the reasons for the higher interest of scientists in the influence of COPD on pregnant woman.&#x0D; The aim of our study was to establish the features of the development pregnancy complications in pregnant women with COPD.&#x0D; Materials and methods. 77 pregnant women with clinically and instrumentally verified signs of COPD were examined and were divided into 2 subgroups depending on the degree of bronchial obstruction: IA - 43 pregnant women with FEV1≥80%, IB - 34 pregnant women with FEV1 50-79%. The control group consisted of 27 healthy pregnant women. The cytokine profile was determined and a correlational interaction with the degree of bronchial obstruction and the frequency of obstetric and perinatal complications was established.&#x0D; The results. Our analysis of cytokine profile indicators in pregnant women with chronic obstructive pulmonary disease at the stage of mild and moderate bronchial obstruction showed a characteristic and reliable increase in the level of pro-inflammatory cytokines (IL-1β, IL-6) and a simultaneous decrease in the level of anti-inflammatory IL-10 (p≤0.05).&#x0D; We established that an increase in the degree of bronchial obstruction is also associated with a higher frequency of detection of such pregnancy and childbirth complications as anemia, respectively, by 3.1 times, the threatened of premature birth by 9 times, preeclampsia by 7 times, placental dysfunction by 3.4 times, intrauterine growth restriction 8 times, premature birth 3.5 times, premature rupture of membranes during labor 4 times, and fetal distress 3 times higher compared to the control group.&#x0D; Conclusions. COPD in pregnant women is characterized by systemic disturbances in the cytokine balance and is accompanied by a significant increase in the frequency of obstetric and perinatal complications, the frequency of which depends on the degree of bronchial obstruction.&#x0D; &#x0D; &#x0D; &#x0D;

Detection of Potential Arbovirus Infections and Pregnancy Complications in Pregnant Women in Jamaica Using a Smartphone App (ZIKApp): Pilot Evaluation Study.

BackgroundThere is growing evidence of the benefits of mobile health technology, which include symptom tracking apps for research, surveillance, and prevention. No study has yet addressed arbovirus symptom tracking in pregnancy.ObjectiveThis study aimed to evaluate the use of a smartphone app (ZIKApp) to self-report arbovirus symptoms and pregnancy complications and to assess compliance with daily symptom diaries during pregnancy in a cohort of women in an arbovirus-endemic, subtropical, middle-income country (Jamaica).MethodsPregnant women aged ≥16 years, having a smartphone, and planning on giving birth at the recruiting center were enrolled between February 2020 and July 2020. ZIKApp comprised a daily symptom diary based on algorithms to identify potential episodes of arbovirus infection and pregnancy complications. Sociodemographic, epidemiological, and obstetric information was collected at enrollment, with additional review of medical records, and users’ perception was collected through an exit survey. Descriptive analyses and logistic regression analysis of possible factors associated with diary adherence were performed.ResultsOf the 173 women enrolled, 157 (90.8%) used ZIKApp for a median duration of 155 (IQR 127-173) days until pregnancy end, 6 (3.5%) used the app for <7 days, and 10 (5.8%) exited the study early. For each successive 30-day period from enrollment up to 150 days after enrollment, of these 157 women, 121 (77.1%) to 129 (82.2%) completed their daily symptom diary; 50 (31.8%) to 56 (35.7%) did so on the same day. Overall, 31.8% (50/157) of the women had good adherence to diary reporting (ie, they completed the task on the same day or 2 to 3 days later for ≥80% of the days enrolled). There were 3-fold higher odds of good adherence for participants aged >34 years versus those aged 25 to 29 years (adjusted odds ratio 3.14, 95% CI 1.10-8.98) and 2-fold higher odds for women with tertiary versus secondary education (adjusted odds ratio 2.26, 95% CI 1.06-4.83). Of the 161 women who ever made a diary entry, 5454 individual symptom reports were made (median 17 per woman; IQR 4-42; range 0-278); 9 (5.6%) women reported symptom combinations triggering a potential arbovirus episode (none had an adverse pregnancy outcome) and 55 (34.2%) reported painful uterine contractions or vaginal bleeding, mainly in the month before delivery. Overall, 51.8% (71/137) of the women rated the app as an excellent experience and were less likely to be poor diary adherers (P=.04) and 99.3% (138/139) reported that the app was easy to understand and use.ConclusionsThis pilot found a high adherence to ZIKApp. It demonstrated the feasibility and usability of the app in an arbovirus-endemic region, supporting its future development to contribute to surveillance and diagnosis of arbovirus infections in pregnancy and to optimize maternal care.

The Association Between High Hemoglobin Levels and Pregnancy Complications, Gestational Diabetes and Hypertension, Among Palestinian Women.

Introduction: Gestational diabetes mellitus (GDM) and hypertensive disorders of pregnancy (HDP) are the principal causes of maternal morbidity and mortality. The maternal morbidity and mortality burden for Palestinian women is relatively high, suggesting a substandard quality of care. Therefore, an early diagnosis of GDM and gestational hypertension (GH) can improve prenatal care for pregnant women and improve pregnancy outcomes. Previous studies demonstrated that elevated Hb levels in the first trimester indicate possible pregnancy complications and should not only be considered as good iron status. However, ethnic differences could play a role in determining the magnitude of the association. We hypothesized that high Hb levels (≥12.5 g/dl) in the first trimester (6-13 gestational weeks, GW) are associated with increased risk of fasting blood sugar (FBS) ≥126 mg/dl, systolic blood pressure (SBP) ≥140 mmHg, and diastolic blood pressure (DBP) ≥90 mmHg among pregnant Palestinian women visiting prenatal clinics in Palestine.Methods: Medical records (N=5263) were reviewed for singleton pregnancies who had their first maternity care clinic visit (6-13 GW) at primary healthcare centers of the Palestinian Ministry of Health in the north of the West Bank in 2018 and 2019. Women were excluded if they had FBS ≥92 mg/dl, SBP ≥140 mmHg, DBP ≥90 mmHg, ultrasound-based gestational age >13 weeks, or who were previously diagnosed with diabetes mellites, GDM, hypertension, GH, taking drugs for these conditions, or were smoking during pregnancy. Hb levels in g/dl were divided to low (<11.0), normal (11-12.49), and high (≥12.5). The associations between high hemoglobin levels and pregnancy complications in pregnant women were assessed by calculating the odds ratios (OR) and their 95% confidence intervals (CIs) using logistic regression. P-values of <0.05 were considered significant.Results: The final number of eligible records was 2565. Pregnant women with high Hb levels in the first trimester were at higher risk of high FBS (≥126 mg/dl; OR=2.99, 95%CI, [1.675-5.368]) and high systolic blood pressure (≥140 mmHg; OR=3.048, 95%CI, [1.252-7.421]) at 24 GW. Gravidity was significantly associated with decreased risk of high FBS (OR=0.838, 95%CI [0.704-0.991]).Conclusion: Our findings suggest that Hb level at registration could be utilized in predicting the risk of GDM and HP among Palestinian women who never had a previous history of these conditions. The results of this study could have important clinical implications for early screening, which could improve preventive and curative health services to promote the health of pregnant women and children.

The effects of smoking on pregnancy risks in women with polycystic ovary syndrome: a population-based study.

Is there is an association between smoking and pregnancy complications in pregnant women with polycystic ovarian syndrome (PCOS)? There is an increased risk of developing gestational diabetes mellitus (GDM) among women with PCOS who smoke. Smokers are at increased risk of developing Type 2 Diabetes Mellitus (DM). Given the common pathophysiology and shared risk factors between type 2 DM and GDM, we sought to assess whether an association between smoking and the development of GDM exists. This is a retrospective population-based study utilizing data from the HCUP-NIS over 11 years from 2004 to 2014. Pregnant women with PCOS who did smoke were compared to pregnant women with PCOS who did not smoke. A second comparison was made between pregnant smokers with and without PCOS. Of the 443 590 women who smoked during pregnancy and the 14 882 women with PCOS, 631 women were both smokers and diagnosed with PCOS. The Healthcare Cost and Utilization Project-Nationwide Inpatient Sample (HCUP-NIS) is the largest inpatient sample database in the USA and is composed of hospital inpatient stays submitted by hospitals throughout the entire country. Each year, the database provides information relating to 7 million inpatient stays, including patient characteristics, diagnosis and procedures. The data are representative of ∼20% of admissions to US hospitals across 48 states and the District of Columbia. There were no differences in the risks of preterm delivery (aOR1.2; CI 0.8-1.9), placental abruption (aOR1.1; CI 0.4-3.2), pregnancy induced hypertension (aOR1.0; CI 0.7-1.5), rate of operative vaginal delivery (aOR1.5; CI 0.9-2.5) and rates of cesarean section (C/S) (aOR1.0; CI 0.7-1.3) between smoking and non-smoking women with PCOS. A significant association between smoking and GDM was observed in women with PCOS (aOR1.5; CI1.01-2.1). The limitations of our study are its retrospective nature and the fact that it relies on an administrative database. Data regarding smoking and PCOS diagnosis could be skewed due to patients' underreporting, lack of documentation and documentation differences. The public health implications of confirming smoking as a risk for GDM among women with PCOS are many. This can lead to earlier screening in pregnancy of smokers for GDM. Earlier initiation of interventions could decrease fetal complications and possibly have an impact on the life and long-term health of the offspring. Future studies are needed in order to assess whether smoking cessation during pregnancy decreases the risk of GDM in that gestation. No external funding was used. The authors report no competing interests. N/A.

THE CONDITION OF UTEROPLACENTAL HEMODYNAMICS IN PREGNANT WOMEN AS A RESULT OF THE ASSISTED REPRODUCTIVE TECHNOLOGIES APPLICATION

The aim of research. To study in the dynamics of the First trimester of pregnancy the features of hemodynamics in pregnant women after ART .Materials and methods. 299 pregnant women were comprehensively examined: the main group included 249 women whose pregnancy occurred as a result of the ART application. The control group consisted of 50 pregnant women with spontaneous pregnancy and its physiological course, which were registered in antenatal clinic at 6-8 weeks. The I group included 94 women with tubal-peritoneal factor of infertility, the II group was formed by 87 women with endocrine factor of infertility, and the III group included 68 women whose infertility is caused by the male factor.Common clinical and laboratory tests were performed on pregnant women of the examined groups, which included a General analysis of blood, urine, and Doppler measurements of uterine arteries indicators.The results of the research and their discussion. Determination of utero-placental hemodynamics in women of the main group after the ART application indicates the need for their dynamic monitoring during the I trimester of pregnancy.As a result of the analysis of the obtained data, it was found that the highest intensity of hemodynamics in the uterine artery basin at 11-12 weeks of gestation was registered in the group of patients with the physiological course of pregnancy. Thus, the systolic-diastolic ratio in the right and left uterine arteries in these patients was 1,9 (1,8-2,7) and 2,1 (1,9-2,6), respectively.In contrast to the subjects with uncomplicated course (group IV), in pregnant women after the ART application analyzed indicators were significantly higher (1,6 – 1,9 times, p<0,0001). The systolic-diastolic ratio in the right uterine artery in group III was 3,0 (2,4-3,5), and in group I – 3,3 (3,1- 3,4). Similar data were obtained during the curves of blood flow rates analyses the in the left uterine artery – 2,9 (2,1-3,5) and 3,0 (2,7-3,6), respectively.The highest peripheral resistance, both in the right (3,6 (3,4-3,7)) and in the left (3,5 (3,2-3,8)) uterine arteries, was registered naturally in group II pregnant women.Own research has shown that the vast majority of 36 (72,0%) patients with uncomplicated course and favorable gestational outcome at 11-12 weeks of pregnancy did not register blood flow in the interval space. Less than one-third of the patients - 14 (28,0%) color Doppler mapping revealed continuous venous-like blood flow. Arterioid-like pulsating type of flow does not reveal any one pregnant in this group.In contrast, the vast majority - 50 (73,5%) of group I pregnant women registered two types of blood flow in the intervertebral space: pulsating arterioid and continuous venous flow. Only 18 (26,5%) patients of this group the blood flow in intervention space was not determined.Conclusions. The results of the research allow us to attribute Doppler to highly informative research methods, which makes it possible to predict pregnancy complications in pregnant women as a result of art quite effectively. Pregnant women with no hemodynamic abnormalities in the utero-placental pool in combination with normal ultrasound data, including assessment of the fetal condition, constitute a group with a truly low risk of an adverse outcome

Features of asthma treatment during pregnancy

Study goal. To analyse asthma therapy in pregnant women with bronchial asthma at a period since 2002 to 2017. Materials and methods. 3890 pregnant women with asthma were examined and followed up during pregnancy at a period since 2002 to 2017. Comprehensive clinicalfunctional examination was conducted. Patients were under surveillance of the obstetriciangynecologist during the whole pregnancy, standard procedures were carried out, and the frequency of complications of pregnancy was estimated. Basic therapy of asthma was compared in groups with the persistent asthma duration, followed up since 2002 to 2009 (1 group) and since 2010 to 2017 (2 group). Also, frequency of pregnancy complications was estimated in these groups. Results. The second group (2010-2017) demonstrated reliably lower frequency of threatening abortion, hypertension and preeclampsia. At the same time the frequency of inhaled corticosteroids (ICS) administration as a part of the combined therapy increased from 21.79% to 63.87% (almost to three times) in comparison with the first group (2002-2009). Conclusions. Combined therapy with ICS/LABA provides most complete control of bronchial asthma, and decreases frequency of pregnancy complications in pregnant women with BA.

The effects of probiotics supplementation on metabolic health in pregnant women: An evidence based meta-analysis.

The prevalence of maternal obesity and gestational diabetes mellitus (GDM) is increasing rapidly. Probiotics supplementation have been shown to improve metabolic health in humans. In our study, we aimed to evaluate the effects of probiotics supplementation on metabolic health and pregnancy complications in pregnant women. The literature search, data extraction and quality assessment were performed, and data were synthesized in accordance with standardized guidelines. Ten randomized clinical trials with eligible data were included in our meta-analysis. For pregnant women with GDM, we found negative correlations between probiotics supplementation and fasting serum insulin (OR -2.94, 95%CI [-5.69, -0.20], p = 0.04) and homoeostasis model assessment for insulin resistance (HOMA-IR) (OR -0.65, 95%CI [-1.18, -0.11], p = 0.02). There were no significant correlations between probiotics supplementation and lipid levels in women with GDM, including total cholesterol (OR -2.72, 95%CI [-17.18, 11.74], P = 0.71), high density lipoprotein cholesterol (HDL-c) (OR -0.29, 95%CI [-3.60, 3.03], P = 0.87), low density lipoprotein cholesterol (LDL-c) (OR -0.38, 95%CI [-18.54, 17.79], P = 0.97), or triglycerides (OR -12.83, 95%CI [-36.63, 10.97], P = 0.29). For healthy pregnant women, probiotics supplementation were negatively associated with fasting serum insulin (OR -3.76, 95%CI [-4.29, -3.23], P < 0.00001) and HOMA-IR (OR -0.57, 95%CI [-1.08, -0.06], p = 0.03). However, no significant correlations were observed between probiotics supplementation and fasting plasma glucose (FPG) (OR -2.02, 95%CI [-5.56, 1.52], p = 0.26). Thus, our study revealed that probiotics supplementation during pregnancy have beneficial effects on glucose metabolism, rather than lipid metabolism among pregnant women.

Group B streptococci cultured in urine during pregnancy associated with preterm delivery: a selection problem?

Objective: To investigate an association between Group B streptococci (GBS) in urine culture during pregnancy and preterm delivery.Methods: A population-based cohort consisted of all the pregnant women (n = 36,097) from the catchment area of Lillebaelt Hospital, Denmark, during the period January 2002 –December 2012. The cohort of 34,285 singleton pregnancies used in this study was divided into three groups. Group I (N = 249) included women whose urine culture was positive for GBS; group II (N = 5765) included women whose urine culture was negative for GBS; and group III (N = 28 271) included women whose urine had not been cultured during pregnancy. Primary outcome was preterm delivery before 37 weeks’ gestation (PTD).Results: We did not find an association between PTD and GBS bacteriuria in the cultured groups (odds ratios (OR) = 0.89; 95% CI: 0.5–1.4) (Table 1). After controlling for potential confounders, the PTD remained not associated with GBS bacteriuria (adjusted OR = 0.99; 95% CI: 0.6–1.6). Combined, the cultured groups (I and II) were associated with a statistically significant higher risk for PTD, when compared with the group with no urine specimens taken for culture (OR = 1.96; 95% CI: 1.8–2.2 and adjusted or 1.80; 95% CI 1.6–2.0). The cultured group of women differed considerably from the group of women with no urine specimens taken for culture on the vast majority of variables examined.Conclusions: No association between asymptomatic GBS bacteriuria and preterm delivery among women with singleton pregnancy and urine specimens cultured during pregnancy was found. Previous suggestions of such association may have been compromised by a selection problem for testing due to a high-risk profile of pregnancy complications in pregnant women selected for urine culture.

Antepartum Dalteparin Versus No Antepartum Dalteparin for the Prevention of Pregnancy Complications in Pregnant Women With Thrombophilia (TIPPS)

Summary Background Thrombophilias are common disorders that increase the risk of pregnancy-associated venous thromboembolism and pregnancy loss and can also increase the risk of placenta-mediated pregnancy complications (severe pre-eclampsia, small-for-gestational-age infants, and placental abruption). We postulated that antepartum dalteparin would reduce these complications in pregnant women with thrombophilia. Methods In this open-label randomised trial undertaken in 36 tertiary care centres in five countries, we enrolled consenting pregnant women with thrombophilia at increased risk of venous thromboembolism or with previous placenta-mediated pregnancy complications. Eligible participants were randomly allocated in a 1:1 ratio to either antepartum prophylactic dose dalteparin (5000 international units once daily up to 20 weeks' gestation, and twice daily thereafter until at least 37 weeks' gestation) or to no antepartum dalteparin (control group). Randomisation was done by a web-based randomisation system, and was stratified by country and gestational age at randomisation day with a permuted block design (block sizes 4 and 8). At randomisation, site pharmacists (or delegates) received a randomisation number and treatment allocation (by fax and/or e-mail) from the central web randomisation system and then dispensed study drug to the local coordinator. Patients and study personnel were not masked to treatment assignment, but the outcome adjudicators were masked. The primary composite outcome was independently adjudicated severe or early-onset pre-eclampsia, small-for-gestational-age infant (birthweight Findings Between Feb 28, 2000, and Sept 14, 2012, 292 women consented to participate and were randomly assigned to the two groups. Three women were excluded after randomisation because of ineligibility (two in the antepartum dalteparin group and one in the control group), leaving 146 women assigned to antepartum dalteparin and 143 assigned to no antepartum dalteparin. Some patients crossed over to the other group during treatment, and therefore for on-treatment and safety analysis there were 143 patients in the dalteparin group and 141 in the no dalteparin group. Dalteparin did not reduce the incidence of the primary composite outcome in both intention-to-treat analysis (dalteparin 25/146 [17·1%; 95% CI 11·4–24·2%] vs no dalteparin 27/143 [18·9%; 95% CI 12·8–26·3%]; risk difference −1·8% [95% CI −10·6% to 7·1%)) and on-treatment analysis (dalteparin 28/143 [19·6%] vs no dalteparin 24/141 [17·0%]; risk difference +2·6% [95% CI −6·4 to 11·6%]). In safety analysis, the occurrence of major bleeding did not differ between the two groups. However, minor bleeding was more common in the dalteparin group (28/143 [19·6%]) than in the no dalteparin group (13/141 [9·2%]; risk difference 10·4%, 95% CI 2·3–18·4; p=0·01). Interpretation Antepartum prophylactic dalteparin does not reduce the occurrence of venous thromboembolism, pregnancy loss, or placenta-mediated pregnancy complications in pregnant women with thrombophilia at high risk of these complications and is associated with an increased risk of minor bleeding. Funding Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, and Pharmacia and UpJohn.

Antepartum dalteparin versus no antepartum dalteparin for the prevention of pregnancy complications in pregnant women with thrombophilia (TIPPS): a multinational open-label randomised trial

Thrombophilias are common disorders that increase the risk of pregnancy-associated venous thromboembolism and pregnancy loss and can also increase the risk of placenta-mediated pregnancy complications (severe pre-eclampsia, small-for-gestational-age infants, and placental abruption). We postulated that antepartum dalteparin would reduce these complications in pregnant women with thrombophilia. In this open-label randomised trial undertaken in 36 tertiary care centres in five countries, we enrolled consenting pregnant women with thrombophilia at increased risk of venous thromboembolism or with previous placenta-mediated pregnancy complications. Eligible participants were randomly allocated in a 1:1 ratio to either antepartum prophylactic dose dalteparin (5000 international units once daily up to 20 weeks' gestation, and twice daily thereafter until at least 37 weeks' gestation) or to no antepartum dalteparin (control group). Randomisation was done by a web-based randomisation system, and was stratified by country and gestational age at randomisation day with a permuted block design (block sizes 4 and 8). At randomisation, site pharmacists (or delegates) received a randomisation number and treatment allocation (by fax and/or e-mail) from the central web randomisation system and then dispensed study drug to the local coordinator. Patients and study personnel were not masked to treatment assignment, but the outcome adjudicators were masked. The primary composite outcome was independently adjudicated severe or early-onset pre-eclampsia, small-for-gestational-age infant (birthweight <10th percentile), pregnancy loss, or venous thromboembolism. We did intention-to-treat and on-treatment analyses. This trial is registered with ClinicalTrials.gov, number NCT00967382, and with Current Controlled Trials, number ISRCTN87441504. Between Feb 28, 2000, and Sept 14, 2012, 292 women consented to participate and were randomly assigned to the two groups. Three women were excluded after randomisation because of ineligibility (two in the antepartum dalteparin group and one in the control group), leaving 146 women assigned to antepartum dalteparin and 143 assigned to no antepartum dalteparin. Some patients crossed over to the other group during treatment, and therefore for on-treatment and safety analysis there were 143 patients in the dalteparin group and 141 in the no dalteparin group. Dalteparin did not reduce the incidence of the primary composite outcome in both intention-to-treat analysis (dalteparin 25/146 [17·1%; 95% CI 11·4-24·2%] vs no dalteparin 27/143 [18·9%; 95% CI 12·8-26·3%]; risk difference -1·8% [95% CI -10·6% to 7·1%)) and on-treatment analysis (dalteparin 28/143 [19·6%] vs no dalteparin 24/141 [17·0%]; risk difference +2·6% [95% CI -6·4 to 11·6%]). In safety analysis, the occurrence of major bleeding did not differ between the two groups. However, minor bleeding was more common in the dalteparin group (28/143 [19·6%]) than in the no dalteparin group (13/141 [9·2%]; risk difference 10·4%, 95% CI 2·3-18·4; p=0·01). Antepartum prophylactic dalteparin does not reduce the occurrence of venous thromboembolism, pregnancy loss, or placenta-mediated pregnancy complications in pregnant women with thrombophilia at high risk of these complications and is associated with an increased risk of minor bleeding. Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, and Pharmacia and UpJohn.

Monovalent H1N1 influenza vaccine safety in pregnant women, risks for acute adverse events

ObjectiveTo assess risks for acute adverse events and pregnancy complications in pregnant women following monovalent 2009 H1N1 inactivated influenza (MIV) vaccination. MethodsWithin the Vaccine Safety Datalink, we compared rates of pre-specified medically attended events (MAE) occurring within 42 days of MIV vaccination to those occurring in matched cohorts that at the same gestational age were either unvaccinated or received seasonal trivalent inactivated influenza (TIV) vaccine. Using generalized estimating equation method, with a Poisson distribution and log link, we calculated adjusted incident rate ratios (AIRR). ResultsAmong 9349 women receiving MIV in any trimester, only one MAE occurred 0–3 days following MIV, an allergic reaction. No cases of Guillain–Barré syndrome, Bell's palsy, or transverse myelitis occurred 1–42 days after MIV. Compared to women receiving TIV and to unvaccinated women, risks for acute MAEs were not increased following MIV for any outcome. Hyperemesis was the most common adverse event in the MIV, TIV, and unvaccinated groups, occurring at a rate of about 4% over a 42-day period in all groups. Over a 42-day window, among all groups, incident gestational diabetes occurred at a rate of 3% and thrombocytopenia occurred at a rate of approximately 0.3%. Among women receiving MIV during pregnancy, increased risks for these and other less common obstetric events were not detected. ConclusionIn this large cohort of pregnant women no acute safety signals were identified within 6 weeks of receipt of MIV.

Correlation between Body Mass Index and Central Adiposity with Pregnancy Complications in Pregnant Women.

The prevalence of obesity is increasing throughout the world.Obesity assessed by body mass index (BMI) has shown to be associated with gestational complications while the relationship using waist circumference (WC) is not clear yet. The present study was aimed to determine the relationship between WC and adverse pregnancy complications. In this prospective cohort study, 1140 nulliparous pregnant women at 1st trimester of pregnancy referred to health care centers in Tabriz, Iran were enrolled in 2009-2010. Anthropometric indexes including (weight, height and WC) were measured using standardized measures and methods. BMI was classified into normal, overweight and obesity based on WHO classification. Abdominal obesity was defined as WC ≥ 88 cm. Pregnancy complication including gestational diabetes, hypertension and preeclamsia. Data were analyzed using SPSS, version 16. Mean of BMI and WC were 24.32±4.08 kg/m(2), 81.84±9.25cm at 1(st) trimester of pregnancy, respectively. Prevalence of overweight (BMI=25-29.9kg/m(2)) and obesity (BMI>29.9 kg/m(2)) was 27.6%, 8.8%, respectively. Abdominal obesity based on WC was 34.8%. Significant correlations were found between BMI and WC (r=0.73, P =0.0001). Women with BMI>29.9 kg/m(2) and WC>88 cm were more likely to suffer from gestational pregnancy and hypertension, as well as preeclampsia and preterm delivery. Early maternal WC similar to BMI is related with pregnancy complications.