scholarly journals POS0022 PHARMACOVIGILANCE PREGNANCY DATA IN A LARGE POPULATION OF PATIENTS WITH CHRONIC INFLAMMATORY DISEASE EXPOSED TO CERTOLIZUMAB PEGOL: PREGNANCY OUTCOMES AND CONFOUNDERS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 213.2-213
Author(s):  
M. Clowse ◽  
R. Fischer-Betz ◽  
C. Nelson-Piercy ◽  
A. Scheuerle ◽  
T. Kumke ◽  
...  
Keyword(s):  
Birth Weight ◽  
Preterm Birth ◽  
Low Birth Weight ◽  
Pregnancy Outcomes ◽  
Congenital Malformations ◽  
Certolizumab Pegol ◽  
First Trimester ◽  
Research Support ◽  
Safety Database ◽  
Live Births

Background:Chronic inflammatory diseases (CID) in women of reproductive age are increasingly being treated with tumour necrosis factor inhibitors (TNFi), in line with recent guidelines.1 However, data on TNFi-exposed pregnancy outcomes are still limited. Certolizumab pegol (CZP), a PEGylated, Fc-free TNFi, has no/minimal placental transfer from mother to infant during the third trimester.2Objectives:To assess pregnancy outcomes from the UCB Pharmacovigilance safety database from over 1,300 prospectively reported pregnancies with maternal CZP exposure.Methods:Details of CZP-exposed pregnancies from the UCB Pharmacovigilance safety database were reviewed up to November 1, 2020. Analysis was limited to prospectively reported cases with known pregnancy outcomes to avoid potential reporting bias. Confounders (specific CID, non-biologic medications and maternal infection) were evaluated using a multivariate stepwise regression model; results from the confounders analysis are reported as odds ratios (OR) with 95% confidence intervals (CI). Patients with missing information about presence or absence of confounders were excluded from the model.Results:1,392 prospective pregnancies (1,425 fetuses) with maternal CZP exposure and known outcomes were reported (Figure 1). Mean (SD) maternal age was 31.9 (5.1) years. Of these, 1,021/1,392 (73.3%) pregnancies had at least first-trimester CZP exposure and 547/1,392 (39.3%) were exposed during all trimesters. Overall, there were 1,259/1,425 (88.4%) live births, 150/1,425 (10.5%) abortions (miscarriages and terminations), 11/1,425 (0.8%) stillbirths, and 5/1,425 (0.4%) ectopic pregnancies. Congenital malformations were reported in 35/1,425 fetuses (2.5%) and in 30/1,259 live-born infants (2.4%); 26 (2.1%) congenital malformations were major according to the Metropolitan Atlanta Congenital Defects Program criteria. There was no pattern of specific congenital malformations. Preterm births occurred in 124/1,259 (9.8%) live births, and 101/1,259 (8.0%) of infants had low birth weight (<2.5 kg). In the confounders analysis, reported corticosteroid use was independently associated with increased odds of preterm birth (OR [95% CI]: 2.1 [1.3–3.4]; p<0.005) and low birth weight (OR [95% CI]: 1.7 [1.0–2.9]; p<0.05), but decreased odds of abortion (OR [95% CI]: 0.5 [0.3–0.9]; p<0.05). Reported NSAID use was associated with increased odds of abortion (OR [95% CI]: 2.2 [1.2–4.0]; p<0.05), as was methotrexate/leflunomide use (OR [95% CI]: 3.2 [1.7–6.2]; p<0.0005). Maternal infections were associated with increased odds of preterm birth (OR [95% CI]: 1.9 (1.1–3.5; p<0.05). Finally, there was an association between a diagnosis of Crohn’s disease and odds of abortion (OR [95% CI]: 2.5 [1.5–4.1]; p=0.0005), and between rheumatoid arthritis and low birth weight (OR [95% CI]: 1.9 [1.1–3.3]; p<0.05).Conclusion:This prospective analysis, including more than 1,000 pregnancies with CZP exposure in at least the first trimester, represents one of the largest cohorts of pregnancies with known outcomes in patients with CID. Our data confirm the impact of specific CID, concomitant drugs or comorbidities on pregnancy outcomes. In particular, additional use of corticosteroids was highlighted as a risk factor for preterm birth and low birth weight in our cohort of CZP-treated patients. No increase in adverse pregnancy outcomes or specific congenital malformations was observed in CZP-exposed pregnancies, compared to the general population,3,4 which offers further reassurance for women of childbearing age considering CZP treatment.References:[1]Sammaritano LR. Arthritis Rheum 2020;72:529–56;[2]Mariette X. Ann Rheum Dis 2018;77:228–33;[3]Ventura SJ. Natl Vital Stat Rep 2012;60:1–21;[4]Lee H. BMC Pregnancy Childbirth 2020;20:33.Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Megan Clowse Consultant of: UCB Pharma, Grant/research support from: Janssen, Pfizer, Rebecca Fischer-Betz Consultant of: AbbVie, BMS, Celgene, Chugai, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, UCB Pharma, Catherine Nelson-Piercy Consultant of: Alliance Pharma, UCB Pharma, Angela Scheuerle Consultant of: Antiretroviral Pregnancy Registry, Harmony Biosciences, IQVIA, ICON, NovoNordisk, PPD, Roche, Sanofi-Genzyme, Syneos, UCB Pharma, ViiV, Thomas Kumke Shareholder of: UCB Pharma, Employee of: UCB Pharma, Bernard Lauwerys Employee of: UCB Pharma, Rachna Kasliwal Employee of: UCB Pharma, Frauke Förger Speakers bureau: Mepha, Roche, UCB Pharma, Grant/research support from: UCB Pharma.

scholarly journals Pregnancy Outcomes in Subjects Exposed to Certolizumab Pegol

2015 ◽  
Vol 42 (12) ◽  
pp. 2270-2278 ◽  
Author(s):  
Megan E.B. Clowse ◽  
Douglas C. Wolf ◽  
Frauke Förger ◽  
John J. Cush ◽  
Amanda Golembesky ◽  
...  
Keyword(s):  
Pregnancy Outcomes ◽  
Additional Data ◽  
Certolizumab Pegol ◽  
Harmful Effect ◽  
First Trimester ◽  
Safety Database ◽  
Live Births ◽  
Induced Abortions ◽  
Concomitant Medications ◽  
Almost All

Objective.To provide information on pregnancy outcomes in women receiving certolizumab pegol (CZP).Methods.The UCB Pharma safety database was searched for pregnancies through to September 1, 2014. Reports for maternal and paternal CZP exposure were included and outcomes examined, and data on CZP exposure, pregnancy, comorbidities, and infant events were extracted by 2 independent reviewers. Concomitant medications and disease activity were reviewed for clinical trial patients.Results.Of 625 reported pregnancies, 372 (59.5%) had known outcomes. Paternal exposure pregnancies (n = 33) reported 27 live births, 4 miscarriages, 1 induced abortion, and 1 stillbirth. Maternal exposure pregnancies (n = 339) reported 254 live births, 52 miscarriages, 32 induced abortions, and 1 stillbirth. Almost all reported pregnancies had exposure to CZP in the first trimester, when organogenesis takes place, and a third of them continued the drug into the second and/or third trimesters. The most frequent indications for maternal CZP use were Crohn disease (192/339) and rheumatic diseases (118/339). Twelve cases of congenital malformation and a single neonatal death were reported.Conclusion.Analysis of pregnancy outcomes after exposure to CZP supports previous reports, suggesting a lack of harmful effect of maternal CZP exposure on pregnancy outcomes. However, additional data from a larger number of outcomes after exposure and studies including an unexposed comparison group are required to fully evaluate CZP safety and tolerability in pregnancy.

scholarly journals Hemoglobin Concentration and Pregnancy Outcomes: A Systematic Review and Meta-Analysis

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Bunyarit Sukrat ◽  
Chumpon Wilasrusmee ◽  
Boonying Siribumrungwong ◽  
Mark McEvoy ◽  
Chusak Okascharoen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Birth Weight ◽  
Preterm Birth ◽  
Low Birth Weight ◽  
Gestational Age ◽  
Pregnancy Outcomes ◽  
Meta Analysis ◽  
First Trimester ◽  
Third Trimester ◽  
The Third

Objective. To conduct a systematic review and meta-analysis of hemoglobin effect on the pregnancy outcomes.Methods. We searched MEDLINE and SCOPUS from January 1, 1990 to April 10, 2011. Observational studies addressing association between hemoglobin and adverse pregnancy outcomes were selected. Two reviewers independently extracted data. A mixed logistic regression was applied to assess the effects of hemoglobin on preterm birth, low birth weight, and small for gestational age.Results. Seventeen studies were included in poolings. Hemoglobin below 11 g/dL was, respectively, 1.10 (95% CI: 1.02–1.19), 1.17 (95% CI: 1.03–1.32), and 1.14 (95% CI: 1.05–1.24) times higher risk of preterm birth, low birth weight, and small for gestational age than normal hemoglobin in the first trimester. In the third trimester, hemoglobin below 11 g/dL was 1.30 (95% CI: 1.08–1.58) times higher risk of low birth weight. Hemoglobin above 14 g/dL in third trimester decreased the risk of preterm term with ORs of 0.50 (95% CI: 0.26–0.97), but it might be affected by publication bias.Conclusions. Our review suggests that hemoglobin below 11 g/dl increases the risk of preterm birth, low birth weight, and small gestational age in the first trimester and the risk of low birth weight in the third trimester.

Impact of Lockdown Measures during COVID-19 Pandemic on Pregnancy and Preterm Birth

2021 ◽  
Author(s):  
Belal Alshaikh ◽  
Po-Yin Cheung ◽  
Nancy Soliman ◽  
Marie-Anne Brundler ◽  
Kamran Yusuf
Keyword(s):  
Birth Weight ◽  
Preterm Birth ◽  
Low Birth Weight ◽  
Pregnancy Outcomes ◽  
Very Low Birth Weight ◽  
Gestational Hypertension ◽  
Cohort Analysis ◽  
Preterm Births ◽  
Live Births ◽  
Very Preterm

Objective The objective of this study is to assess the effect of the lockdown measures during the coronavirus disease 2019 (COVID-19) pandemic on pregnancy outcomes of women who were not affected by severe acute respiratory syndrome coronavirus 2 infection. Study Design We used data from the perinatal health program and neonatal databases to conduct a cohort analysis of pregnancy outcomes during the COVID-19 lockdown in the Calgary region, Canada. Rates of preterm birth were compared between the lockdown period (March 16 to June 15, 2020) and the corresponding pre-COVID period of 2015 to 2019. We also compared maternal and neonatal characteristics of preterm infants admitted to neonatal intensive care units (NICUs) in Calgary between the two periods. Findings A total of 4,357 and 24,160 live births occurred in the lockdown and corresponding pre-COVID period, respectively. There were 366 (84.0 per 1,000 live births) and 2,240 (92.7 per 1,000 live births) preterm births in the lockdown and corresponding pre-COVID period, respectively (p = 0.07). Rates of very preterm and very-low-birth-weight births were lower in the lockdown period compared with the corresponding pre-COVID period (11.0 vs. 15.6 and 9.0 vs. 14.4 per 1,000 live births, p = 0.02 and p = 0.005, respectively). There was no difference in spontaneous stillbirth between the two periods (3.7 vs. 4.1 per 1,000 live birth, p = 0.71). During the lockdown period, the likelihood of multiple births was lower (risk ratio [RR] 0.73, 95% confidence interval [CI]: 0.60–0.88), while gestational hypertension and clinical chorioamnionitis increased (RR 1.24, 95%CI: 1.10–1.40; RR 1.33, 95%CI 1.10–1.61, respectively). Conclusion Observed rates of very preterm and very-low-birth-weight births decreased during the COVID-19 lockdown. Pregnant women who delivered during the lockdown period were diagnosed with gestational hypertension and chorioamnionitis more frequently than mothers in the corresponding pre-COVID period. Key Points

scholarly journals Pregnancy Outcome during the First COVID 19 Lockdown in Vienna, Austria

2021 ◽  
Vol 18 (7) ◽  
pp. 3782
Author(s):  
Sylvia Kirchengast ◽  
Beda Hartmann
Keyword(s):  
Birth Weight ◽  
Preterm Birth ◽  
Low Birth Weight ◽  
Pregnancy Outcome ◽  
Gestational Age ◽  
Very Low Birth Weight ◽  
Extremely Low Birth Weight ◽  
Negative Effects ◽  
Gestational Length ◽  
Live Births

The COVID 19 pandemic represents a major stress factor for non-infected pregnant women. Although maternal stress during pregnancy increases the risk of preterm birth and intrauterine growth restriction, an increasing number of studies yielded no negative effects of COVID 19 lockdowns on pregnancy outcome. The present study focused on pregnancy outcome during the first COVID 19 lockdown phase in Austria. In particular, it was hypothesized that the national lockdown had no negative effects on birth weight, low birth weight rate and preterm birth rate. In a retrospective medical record-based single center study, the outcome of 669 singleton live births in Vienna Austria during the lockdown phase between March and July 2020 was compared with the pregnancy outcome of 277 live births at the same hospital during the pre-lockdown months of January and February 2020 and, in addition, with the outcome of 28,807 live births between 2005 and 2019. The rate of very low gestational age was significantly lower during the lockdown phase than during the pre-lockdown phase. The rate of low gestational age, however, was slightly higher during the lockdown phase. Mean birth weight was significantly higher during the lockdown phase; the rates of low birth weight, very low birth weight and extremely low birth weight were significantly lower during the lockdown phase. In contrast, maternal gestational weight gain was significantly higher during the lockdown phase. The stressful lockdown phase in Austria seems to have no negative affect on gestational length and newborn weight among non-infected mothers.

scholarly journals Investigation of Metronidazole Use during Pregnancy and Adverse Birth Outcomes

2012 ◽  
Vol 56 (9) ◽  
pp. 4800-4805 ◽  
Author(s):  
Catherine A. Koss ◽  
Dana C. Baras ◽  
Sandra D. Lane ◽  
Richard Aubry ◽  
Michele Marcus ◽  
...  
Keyword(s):  
New York ◽  
Birth Weight ◽  
Preterm Birth ◽  
Low Birth Weight ◽  
Congenital Anomalies ◽  
New York State ◽  
Multivariable Analysis ◽  
Preterm Births ◽  
First Trimester ◽  
First Trimester Of Pregnancy

ABSTRACTTo assess whether treatment with metronidazole during pregnancy is associated with preterm birth, low birth weight, or major congenital anomalies, we conducted chart reviews and an analysis of electronic data from a cohort of women delivering at an urban New York State hospital. Of 2,829 singleton/mother pairs, 922 (32.6%) mothers were treated with metronidazole for clinical indications, 348 (12.3%) during the first trimester of pregnancy and 553 (19.5%) in the second or third trimester. There were 333 (11.8%) preterm births, 262 (9.3%) infants of low birth weight, and 52 infants (1.8%) with congenital anomalies. In multivariable analysis, no association was found between metronidazole treatment and preterm birth (odds ratio [OR], 1.02 [95% confidence interval [CI], 0.80 to 1.32]), low birth weight (OR, 1.05 [95% CI, 0.77 to 1.43]), or treatment in the first trimester and congenital anomalies (OR, 0.86 [0.30 to 2.45]). We found no association between metronidazole treatment during the first or later trimesters of pregnancy and preterm birth, low birth weight, or congenital anomalies.

Risks of Selected Fetal Adverse Pregnancy Outcomes at Advance Maternal Age

2021 ◽  
Vol 15 (8) ◽  
pp. 2468-2471
Author(s):  
Saadia Yasmeen ◽  
Sumayya . ◽  
Javeria Saleem ◽  
Jawairiah Liaqat ◽  
Nadia Pervaiz ◽  
...  
Keyword(s):  
Birth Weight ◽  
Preterm Birth ◽  
Low Birth Weight ◽  
Pregnancy Outcomes ◽  
Maternal Age ◽  
Advanced Maternal Age ◽  
Adverse Pregnancy Outcomes ◽  
Control Group ◽  
Postpartum Women ◽  
Adverse Pregnancy

Background and Aim: Advanced maternal age pregnancy could be referred to as pregnancy after 35 years or older. The prevalence of postponing pregnancies is increasing day by day worldwide. However, limited evidence was found on advanced maternal age pregnancy association with fetal adverse outcomes. The present study aimed to evaluate the frequency of advanced maternal age selected fetal adverse pregnancy outcomes. Place and Duration: Obstetrics & Gynaecology department of Alkhidmat Hospital Kohat and Qazi Hussain Ahmad Medical Complex, Nowshera for duration of six months from November 2020 to April 2021. Materials and Methods: This single-centered retrospective study was conducted on 220 postpartum women in the study group (≥35 years) and 170 control group postpartum women (20-34 years) who delivered at Obstetrics & Gynaecology department of Alkhidmat Hospital Kohat and Qazi Hussain Ahmad Medical Complex, Nowshera after 28 gestational weeks. Individuals who met the inclusion criteria were enrolled and sampled based on randomized control sampling technique for both control and study groups. Data extraction checklist and pretested questionnaire were used for data collection from the maternal charts. Adverse pregnancy outcome and advanced maternal age was correlated adjusted relative risks and strength with a 95% confidence interval. SPSS version 20 was used for data analysis and considered p-value >0.05 as a statistical standard. Results: The adverse neonatal outcomes include low birth weight, preterm birth, and stillbirth with a prevalence 38 (17.4%), 46 (20.8%), and 31 (14.2%) respectively in the study group. In the control group, the incidence of low birth weight, preterm birth, and stillbirth was 21 (12.6%), 15 (14.6%) and 6 (3.5%) respectively. The stillbirth (ARR=3.16 95% CI (1.29–6.03) and preterm deliveries (ARR=2.71 95% CI (1.79–3.86) risk had significantly higher prevalence compared to control group advanced age pregnancy. Insignificance association was found between low birth weight and advanced maternal age. Conclusion: Stillbirth and preterm birth was the adverse fetal outcome significantly related with advanced maternal age pregnancy. There was no significant association between low birth weight and advanced maternal age. Keywords: Maternal age, Fetal Adverse Pregnancy Outcomes

High-risk of preterm birth and low birth weight after oocyte donation IVF: analysis of 133,785 live births

2017 ◽  
Vol 35 (3) ◽  
pp. 318-324 ◽  
Author(s):  
Mohan Shashikant Kamath ◽  
Belavendra Antonisamy ◽  
Mariano Mascarenhas ◽  
Sesh Kamal Sunkara
Keyword(s):  
Birth Weight ◽  
Preterm Birth ◽  
High Risk ◽  
Low Birth Weight ◽  
Oocyte Donation ◽  
Live Births

scholarly journals Changes in live births, preterm birth, low birth weight, and cesarean deliveries in the United States during the SARS-CoV-2 pandemic

2021 ◽  
Author(s):  
Alison Gemmill ◽  
Joan A. Casey ◽  
Ralph Catalano ◽  
Deborah Karasek ◽  
Tim-Allen Bruckner
Keyword(s):  
Time Series ◽  
Birth Weight ◽  
Preterm Birth ◽  
Low Birth Weight ◽  
Cesarean Delivery ◽  
Very Low Birth Weight ◽  
National Level ◽  
Health Indicators ◽  
The United States ◽  
Live Births

Background: The SARS-CoV-2 pandemic and associated social, economic, and clinical disruption have been widely speculated to affect pregnancy decision-making and outcomes. While a few US-based studies have examined subnational changes in fertility, preterm birth, and stillbirth, there remains limited knowledge of how the pandemic impacted childbearing and a broader set of perinatal health indicators at the national-level throughout 2020. Here, we use recently released national-level data to fill this gap. Importantly, we, unlike earlier work, use time-series methods to account for strong temporal patterning (e.g., seasonality, trend) that could otherwise lead to spurious findings. Methods: For the years 2015 to 2020, we obtained national monthly counts of births and rates (per 100 births) for six perinatal indicators: preterm birth (<37 weeks gestation), early preterm birth (<34 weeks gestation), late preterm birth (34-36 weeks gestation), low birth weight birth (<2500 g), very low birth weight birth (<1500 g), and cesarean delivery. We use an interrupted time-series approach to compare the outcomes observed after the pandemic began (March 2020) to those expected had the pandemic not occurred. Results: For total births as well as five of the six indicators (i.e., all but the rate of cesarean delivery), observed values fall well below expected levels (p<.0001 for each test) during the entire pandemic period. Declines in preterm birth and low birth weight were largest in magnitude in both early and later stages of the 2020 pandemic, while those for live births occurred at the end of the year. Discussion: Our findings provide some of the first national evidence of substantial reductions in live births and adverse perinatal outcomes during the SARS-CoV-2 pandemic. Only cesarean delivery appeared unaffected. These declines were not uniform across the pandemic, suggesting that several mechanisms, which require further study, may explain these patterns.

P0231PREGNANCY AND DELIVERY OUTCOMES IN PATIENTS WITH COMPLEMENT GENE VARIANT MEDIATED THROMBOTIC MICROANGIOPATHY

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Natalja Haninger ◽  
Martina Gaggl ◽  
Christof Aigner ◽  
Kain Renate ◽  
Zoltán Prohaszka ◽  
...  
Keyword(s):  
Birth Weight ◽  
Caesarean Section ◽  
Low Birth Weight ◽  
Thrombotic Microangiopathy ◽  
Pregnancy Outcomes ◽  
Gene Variant ◽  
Live Births ◽  
Delivery Outcomes ◽  
Pregnancy And Delivery ◽  
Complement Gene

Abstract Background and Aims In pregnancy and the postpartum period, complement gene variant mediated thrombotic microangiopathy (P-cTMA) can be life threatening for the mother and the child. We describe pregnancy and delivery outcomes of pregnancies a) before cTMA manifestation, b) complicated by P-cTMA, and c) after first manifestation of cTMA in such women. Method This study provides an update of patients enrolled in the Vienna TMA Cohort (VTC) as of January 2020. Demographic and clinical data were retrieved from the electronic and paper-based health care records of our institution and from the Austrian Mother-Child Health Passport. Pregnancy outcomes include live births (full term, moderate to late preterm, very preterm, extremely preterm) or deaths (miscarriage, foetal death, stillbirth, neonatal death). Among delivery outcome we ascertained spontaneous vaginal delivery; Caesarean section, gestational age, birth weight and birth weight categories, birth height, head circumference, Apgar scores, admission to a neonatal intensive care unit, and the presence of malformations. Results We recorded 58 pregnancies (41 live births/21 women, including one set of twins; 4 abortions and 1 stillbirth in 3 women without live births; 1 ongoing pregnancy; successful pregnancies: 40/57=70%) of 25 women (mean age [years] at first pregnancy 28.2±7.4, at cTMA manifestation 33.2±16.5). Currently 6 women have a kidney transplant and 4 have died (each death not related to pregnancy). Detailed pregnancy outcomes are shown in Figure 1. Table 1 indicates delivery outcomes of 41 live births. 6/8 neonates of pregnancies complicated by cTMA were female. Caesarean sections (female: 11/19, 58%; male: 9/24, 38%; p=0.11), preterm deliveries (female: 7/19, 37%; male: 5/24, 21%; p=0.09), and low birth weight (female: 6/19, 32%; male: 3/24, 13%; p=0.02) were more frequent among 43 pooled live births and stillbirths with known sex. Conclusion Overall, pregnancy and delivery outcomes were poor in pregnancies complicated by cTMA as compared to pregnancies before or after cTMA manifestation. The rate of Caesarean section, preterm delivery, and low birth weight was somewhat higher among female as compared to male neonates and stillbirths. Furthermore, neonatal female gender should be explored as risk factor for cTMA manifestation.

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