scholarly journals Safety of vedolizumab in the treatment of pregnant women with inflammatory bowel disease: a targeted literature review

2020 ◽  
Vol 13 ◽  
pp. 175628482095259
Author(s):  
Birgit Terjung ◽  
Renate Schmelz ◽  
Robert Ehehalt ◽  
Jochen Klaus ◽  
Jana Knop ◽  
...  

Background: Crohn’s disease (CD) and ulcerative colitis (UC) commonly affect women in their childbearing years. Vedolizumab (VDZ) is approved for treatment of moderate-to-severe CD and UC, but there is a knowledge gap regarding its use during pregnancy. This targeted literature review describes available evidence on safety of VDZ in pregnant patients in order to offer physicians a detailed and balanced view on persistent data during their decision-making process for an individualized treatment concept. Methods: The search included literature from the MEDLINE database and abstracts of five gastroenterological conferences published until November 2019. Publications were included if pregnancy outcomes in women receiving VDZ or neonatal outcomes in newborns of women previously exposed to VDZ were reported. Results: Out of 196 initially identified records, 18 publications reporting results of five different studies were identified. In total, for 213 of 284 VDZ-exposed documented pregnancies the following pregnancy outcomes were reported: 167 live births (172 infants due to twin births), 1 stillbirth, 35 miscarriages, 10 elective terminations (1 due to detected Down syndrome). Furthermore, during pregnancy, the following complications were observed: seven cases of (pre) eclampsia, three cases of premature rupture of membranes and one case each of placenta previa, chorioamnionitis, pneumonia, first-trimester bleeding, cholestasis, sepsis, or neonatal intraventricular hemorrhage. Based on 172 infants, 30 preterm deliveries (17.4%), 9 cases of low birth weight (5.2%), 5 infections (2.9%), and 6 cases (3.8%) with congenital anomalies were reported. Conclusion: There was no evidence for safety concerns regarding pregnancy outcomes associated with VDZ therapy. Due to the limited scope of included records, further research is needed to understand the safety profile regarding the use of VDZ during pregnancy.

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Kun Wang ◽  
Yu Tian ◽  
Huabo Zheng ◽  
Shengshuai Shan ◽  
Xiaofang Zhao ◽  
...  

Abstract Background The associations between maternal exposure to ambient PM2.5 during pregnancy and the risk of premature rupture of membranes (PROM) and preterm premature rupture of membranes (PPROM) are controversial. And no relevant study has been conducted in Asia. This study aimed to determine the association between maternal exposure to ambient PM2.5 during pregnancy and the risk of (P)PROM. Methods A cohort study including all singleton births in a hospital located in Central China from January 2015 through December 2017 was conducted. Multivariable logistic regression models, stratified analysis, generalized additive model, and two-piece-wise linear regression were conducted to evaluate how exposure to ambient PM2.5 during pregnancy is associated with the risks of PROM and PPROM. Results A total of 4364 participants were included in the final analysis, where 11.71 and 2.34% of births were complicated by PROM and PPROM, respectively. The level of PM2.5 exhibited a degree of seasonal variation, and its median concentrations were 63.7, 59.3, 55.8, and 61.8 μg/m3 for the first trimester, second trimester, third trimester, and the whole duration of pregnancy, respectively. After adjustment for potential confounders, PROM was positively associated with PM2.5 exposure (per 10 μg/m3) [Odds Ratio (OR) = 1.14, 95% Confidence Interval (CI), 1.02–1.26 for the first trimester; OR = 1.09, 95% CI, 1.00–1.18 for the second trimester; OR = 1.13, 95% CI, 1.03–1.24 for the third trimester; OR = 1.35, 95% CI, 1.12–1.63 for the whole pregnancy]. PPROM had positive relationship with PM2.5 exposure (per 10 μg/m3) (OR = 1.17, 95% CI, 0.94–1.45 for first trimester; OR = 1.11, 95% CI, 0.92–1.33 for second trimester; OR = 1.19, 95% CI, 0.99–1.44 for third trimester; OR = 1.53, 95% CI, 1.03–2.27 for the whole pregnancy) Positive trends between the acute exposure window (mean concentration of PM2.5 in the last week and day of pregnancy) and risks of PROM and PPROM were also observed. Conclusions Exposure to ambient PM2.5 during pregnancy was associated with the risk of PROM and PPROM.


2011 ◽  
Vol 9 (2) ◽  
pp. 103-114
Author(s):  
Ditya Yankusuma Setiani

Latar Belakang : Angka Kematian Bayi (AKB) merupakan indikator yang penting untuk mencerminkan keadaan derajat kesehatan di suatu masyarakat. Salah satu kejadian intrapartum yang memiliki kontribusi besar dalam kematian bayi baru lahir adalah asfiksia neonatorum. Asfiksia neonatorum adalah suatu kondisi yang terjadi ketika bayi tidak mendapatkan cukup oksigen selama proses kelahiran. Pengendalian faktor penyebab asfiksia neonatorum sangat penting dalam upaya menurunkan prevalensi terjadinya asfiksia neonatorum. Oleh karena itu perlu dilakukan studi literatur terkait faktor penyebab terjadinya asfiksia neonatorum. Tujuan Penelitian : Mengetahui faktor penyebab terjadinya asfiksia neonatorum. Metode Penelitian : Desain penelitian adalah literatur review. Populasi penelitian ini adalah seluruh artikel hasil penelitian tentang faktor penyebab terjadinya asfiksia neonatorum. Hasil : Hasil literatur review dari lima artikel menunjukkan bahwa faktor penyebab asfiksia neonatorum terdiri dari cairan ketuban dengan pewarnaan meconium, BBLR (Berat Badan Lahir Rendah), persalinan lama, operasi Caesar, ketuban pecah dini, ibu primipara, persalinan rumit, cairan ketuban yang bernoda darah, ibu berumur ? 35 tahun, primigravida, tali pusat ketat, gawat janin intrapartum, malpresentasi janin, dilahirkan melalui rute vagina dengan bantuan vakum, dilahirkan pada malam hari dan dilahirkan dengan bantuan dokter magang sendiri. Kesimpulan : berdasarkan review dari literatur ini dapat disimpulkan bahwa cairan ketuban bernoda meconium, BBLR, persalinan lama dan ketuban pecah dini merupakan faktor penyebab asfiksia neonatorum yang memiliki pengaruh lebih besar.   Kata Kunci : Asfiksia Neonatorum, Faktor Penyebab   REVIEW LITERATURE: FACTORS CAUSING THE OCCURRENCE OF ASPHYXIA NEONATORUM   Ditya Yankusuma Setiani, Lilik Sriwiyati   ABSTRACT Background : Infant Mortality Rate (IMR) is an important indicator to reflect the state of health status in a society. One of the intrapartum events that has a large contribution to the death of newborns is neonatal asphyxia. Asphyxia neonatorum is a condition that occurs when the baby does not get enough oxygen during the birth process. Therefore, controlling the factors that cause neonatal disease is very important in aneffort to reduce the prevalence of neonatal asphyxia. Objectives : To determine the factors causing the incidence of neonatal asphyxia. Methode : The research design of this scientific paper is a literature review. The population of this study were all journals of research results on the factors causing the occurrence of asphyxia neonatorum. Results : The results of the literature review from the 5 journals show the causes of neonatal asphyxia consisting of meconium stained amniotic fluid, low birth weight (LBW), prolonged labor, caesarean section, premature rupture of membranes, primiparous mothers, complicated labor, fluids. Blood stained amniotic fluid, mother ? 35 years old, primigravida, tight umbilical cord, intrapartum fetal distress, fetal malpresentation, via vaginal route with vacuum assistance, assistance at night and assisting with the help of the interns themselves. Conclusion : This study can show that meconium stained amniotic fluid, low birth weight, prolonged labor and premature rupture of membranes are factors causing neonatal asphyxia which have a greater effect.   Keywords: Asphyxia Neonatorum, Causative Factor


2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 194-195
Author(s):  
P Tandon ◽  
Y Hanna ◽  
J Cepo ◽  
C Maxwell ◽  
V W Huang

Abstract Background Patients with inflammatory bowel disease (IBD) are at a risk of inadequate gestational weight-gain (GWG) which in turn may increase the risk of adverse pregnancy outcomes. Aims To determine the risk factors for inadequate GWG in these patients and to determine the impact on adverse pregnancy outcomes. Methods Pregnant patients with IBD, both ulcerative colitis (UC) and Crohn’s disease (CD), were identified retrospectively at the Mount Sinai Hospital from 2016 to 2020. Total gestational weight-gain (GWG) was calculated as the difference of the weight recorded at time of labor and pre-pregnancy weight. GWG was further stratified into less than adequate, adequate, and more than adequate based on the pre-pregnancy body-mass index and standards set by the U.S. Institute of Medicine. Pregnancy-related outcomes were also recorded for each patient. Disease activity was recorded at each trimester visit and defined by a fecal calprotectin (FCP) > 250 ug/g. Differences in the mean GWG were compared using independent T-test with standard deviations (SD) whereas categorical variables were compared using the Chi-square (x2) test. Results 71 pregnancies in 71 patients were included (33 UC and 38 CD). Thirteen patients (18.3%) had less than adequate, 23 (32.4%) adequate, and 35 (49.3%) more than adequate GWG. Of the 33 patients with UC, 4 (12.2%) had less than adequate, 15 (45.5%) had adequate, and 14 (42.4%) had more than adequate GWG. Of the 38 patients with CD, 9 (23.7%) had less than adequate, 8 (21.1%) had adequate, and 21 (55.3%) had more than adequate GWG (p=0.07) for CD vs. UC). In those with CD, both fistulizing and stricturing CD phenotypes appeared to be numerically associated with inadequate GWG. Specifically, none of the 13 patients with fistulizing CD had adequate GWG compared to 32.0% (8/25) in those without fistulizing disease (p=0.07). Similarly, only 2/22 (9.1%) of those with stricturing CD had adequate GWG compared to 6/16 (37.5%) in those without stricturing disease (p=0.07). Furthermore, of seven patients with active disease in the first trimester, only one had adequate GWG (14.3%) compared to 37.5% (3/8) of those in clinical remission (p=0.044). Active disease in trimesters two and three was not associated with inadequate GWG. Finally, the mean GWG was higher in those undergoing Cesarean (37.8 kg (SD 14.1) vs. 30.4 kg (SD 10.5), p=0.014)) and emergency Cesarean delivery (43.5 kg (SD 17.6) vs. 31.9 kg (SD 10.7) (p=0.004) compared to vaginal delivery respectively. Conclusions Patients with CD, but not UC, and those with active disease in the first trimester, are at risk of inadequate GWG during pregnancy. In those with larger GWG, a higher rate of emergency Cesarean birth was noted. Optimal intervention to achieve recommended gestational weight-gains in patients with IBD remains to be determined. Funding Agencies None


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e047900
Author(s):  
Min Du ◽  
Jie Yang ◽  
Na Han ◽  
Min Liu ◽  
Jue Liu

ObjectivesThe secondary impacts of the COVID-19 pandemic on adverse maternal and neonatal outcomes remain unclear. In this study, we aimed to evaluate the association between the COVID-19 pandemic and the risk for adverse pregnancy outcomes.DesignWe conduced retrospective analyses on two cohorts comprising 7699 pregnant women in Beijing, China, and compared pregnancy outcomes between the pre-COVID-2019 cohort (women who delivered from 20 May 2019 to 30 November 2019) and the COVID-2019 cohort (women who delivered from 20 January 2020 to 31 July 2020). The secondary impacts of the COVID-2019 pandemic on pregnancy outcomes were assessed by using multivariate log-binomial regression models, and we used interrupted time-series (ITS) regression analysis to further control the effects of time-trends.SettingOne tertiary-level centre in Beijing, ChinaParticipants7699 pregnant women.ResultsCompared with women in the pre-COVID-19 pandemic group, pregnant women during the COVID-2019 pandemic were more likely to be of advanced age, exhibit insufficient or excessive gestational weight gain and show a family history of chronic disease (all p<0.05). After controlling for other confounding factors, the risk of premature rupture of membranes and foetal distress was increased by 11% (95% CI, 1.04 to 1.18; p<0.01) and 14% (95% CI, 1.01 to 1.29; p<0.05), respectively, during the COVID-2019 pandemic. The association still remained in the ITS analysis after additionally controlling for time-trends (all p<0.01). We uncovered no other associations between the COVID-19 pandemic and other pregnancy outcomes (p>0.05).ConclusionsDuring the COVID-19 pandemic, more women manifested either insufficient or excessive gestational weight gain; and the risk of premature rupture of membranes and foetal distress was also higher during the pandemic.


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