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3. Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study

Author

Villar, Jose, Conti, Constanza P Soto, Gunier, Robert B, Ariff, Shabina, Craik, Rachel, Cavoretto, Paolo I, Rauch, Stephen, Gandino, Serena, Nieto, Ricardo, Winsey, Adele, Menis, Camilla, Rodriguez, Gabriel B, Savasi, Valeria, Tug, Niyazi, Deantoni, Sonia, Fabre, Marta, de Tejada, Begoña Martinez, Rodriguez-Sibaja, Maria Jose, Livio, Stefania, Napolitano, Raffaele, Maiz, Nerea, Sobrero, Helena, Peterson, Ashley, Deruelle, Philippe, Giudice, Carolina, Teji, Jagjit S, Casale, Roberto A, Salomon, Laurent J, Prefumo, Federico, Ismail, Leila Cheikh, Gravett, Michael G, Vale, Marynéa, Hernández, Valeria, Sentilhes, Loïc, Easter, Sarah R, Capelli, Carola, Marler, Emily, Cáceres, Daniela M, Crespo, Guadalupe Albornoz, Ernawati, Ernawati, Lipschuetz, Michal, Takahashi, Ken, Vecchiarelli, Carmen, Hubka, Teresa, Ikenoue, Satoru, Tavchioska, Gabriela, Bako, Babagana, Ayede, Adejumoke I, Eskenazi, Brenda, Thornton, Jim G, Bhutta, Zulfiqar A, Kennedy, Stephen H, Papageorghiou, Aris T, and Consortium, INTERCOVID-2022 International

Subjects
Prevention, Pediatric, Lung, Clinical Research, Immunization, Clinical Trials and Supportive Activities, Vaccine Related, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Reproductive health and childbirth, Good Health and Well Being, Pregnancy, Infant, Newborn, Humans, Female, Male, Pregnancy Outcome, Vaccine Efficacy, COVID-19, SARS-CoV-2, COVID-19 Testing, Prospective Studies, Mothers, INTERCOVID-2022 International Consortium, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundIn 2021, we showed an increased risk associated with COVID-19 in pregnancy. Since then, the SARS-CoV-2 virus has undergone genetic mutations. We aimed to examine the effects on maternal and perinatal outcomes of COVID-19 during pregnancy, and evaluate vaccine effectiveness, when omicron (B.1.1.529) was the variant of concern.MethodsINTERCOVID-2022 is a large, prospective, observational study, involving 41 hospitals across 18 countries. Each woman with real-time PCR or rapid test, laboratory-confirmed COVID-19 in pregnancy was compared with two unmatched women without a COVID-19 diagnosis who were recruited concomitantly and consecutively in pregnancy or at delivery. Mother and neonate dyads were followed until hospital discharge. Primary outcomes were maternal morbidity and mortality index (MMMI), severe neonatal morbidity index (SNMI), and severe perinatal morbidity and mortality index (SPMMI). Vaccine effectiveness was estimated, adjusted by maternal risk profile.FindingsWe enrolled 4618 pregnant women from Nov 27, 2021 (the day after WHO declared omicron a variant of concern), to June 30, 2022: 1545 (33%) women had a COVID-19 diagnosis (median gestation 36·7 weeks [IQR 29·0-38·9]) and 3073 (67%) women, with similar demographic characteristics, did not have a COVID-19 diagnosis. Overall, women with a diagnosis had an increased risk for MMMI (relative risk [RR] 1·16 [95% CI 1·03-1·31]) and SPMMI (RR 1·21 [95% CI 1·00-1·46]). Women with a diagnosis, compared with those without a diagnosis, also had increased risks of SNMI (RR 1·23 [95% CI 0·88-1·71]), although the lower bounds of the 95% CI crossed unity. Unvaccinated women with a COVID-19 diagnosis had a greater risk of MMMI (RR 1·36 [95% CI 1·12-1·65]). Severe COVID-19 symptoms in the total sample increased the risk of severe maternal complications (RR 2·51 [95% CI 1·84-3·43]), perinatal complications (RR 1·84 [95% CI 1·02-3·34]), and referral, intensive care unit (ICU) admission, or death (RR 11·83 [95% CI 6·67-20·97]). Severe COVID-19 symptoms in unvaccinated women increased the risk of MMMI (RR 2·88 [95% CI 2·02-4·12]) and referral, ICU admission, or death (RR 20·82 [95% CI 10·44-41·54]). 2886 (63%) of 4618 total participants had at least a single dose of any vaccine, and 2476 (54%) of 4618 had either complete or booster doses. Vaccine effectiveness (all vaccines combined) for severe complications of COVID-19 for all women with a complete regimen was 48% (95% CI 22-65) and 76% (47-89) after a booster dose. For women with a COVID-19 diagnosis, vaccine effectiveness of all vaccines combined for women with a complete regimen was 74% (95% CI 48-87) and 91% (65-98) after a booster dose.InterpretationCOVID-19 in pregnancy, during the first 6 months of omicron as the variant of concern, was associated with increased risk of severe maternal morbidity and mortality, especially among symptomatic and unvaccinated women. Women with complete or boosted vaccine doses had reduced risk for severe symptoms, complications, and death. Vaccination coverage among pregnant women remains a priority.FundingNone.

Published
2023

11. Maternal vaccination against COVID-19 and neonatal outcomes during Omicron: INTERCOVID-2022 study

Author

Barros, Fernando C., Gunier, Robert B., Rego, Albertina, Sentilhes, Loïc, Rauch, Stephen, Gandino, Serena, Teji, Jagjit S., Thornton, Jim G., Kachikis, Alisa B., Nieto, Ricardo, Craik, Rachel, Cavoretto, Paolo I., Winsey, Adele, Roggero, Paola, Rodriguez, Gabriel B., Savasi, Valeria, Kalafat, Erkan, Giuliani, Francesca, Fabre, Marta, Benski, Anne Caroline, Coronado-Zarco, Irma Alejandra, Livio, Stefania, Ostrovska, Adela, Maiz, Nerea, Castedo Camacho, Fabiola R., Peterson, Ashley, Deruelle, Philippe, Giudice, Carolina, Casale, Roberto A., Salomon, Laurent J., Soto Conti, Constanza P., Prefumo, Federico, Mohamed Elbayoumy, Ehab Zakaria, Vale, Marynéa, Hernández, Valeria, Chandler, Katherine, Risso, Milagros, Marler, Emily, Cáceres, Daniela M., Crespo, Guadalupe Albornoz, Ernawati, Ernawati, Lipschuetz, Michal, Ariff, Shabina, Takahashi, Ken, Vecchiarelli, Carmen, Hubka, Teresa, Ikenoue, Satoru, Tavchioska, Gabriela, Bako, Babagana, Ayede, Adejumoke I., Eskenazi, Brenda, Bhutta, Zulfiqar A., Kennedy, Stephen H., Papageorghiou, Aris T., and Villar, Jose

Published
2024
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32. Machine Learning in Electronic Health Records: Identifying High-Risk Obstetric Patients Pre and During Labor.

Author

LIPSCHUETZ, Michal, GUEDALIA, Joshua, COHEN, Sarah M., UNGER, Ron, YAGEL, Simcha, and SOMPOLINSKY, Yishai

Abstract

Our goal is to apply artificial intelligence (AI) and statistical analysis to understand the relationship between various factors and outcomes during pregnancy and labor and delivery, in order to personalize birth management and reduce complications for both mothers and newborns. We use a structured electronic health records database with data from approximately 130,000 births to train, test and validate our models. We apply machine learning (ML) methods to predict various obstetrical outcomes before and during labor, with the aim of improving patient care management in the delivery ward. Using a large cohort of data (~180 million data points), we then demonstrated that ML models can predict successful vaginal delivery, in the general population as well as a sub-cohort of women attempting trial of labor after a cesarean delivery. The real-time dynamic model showed increasing rates of accuracy as the delivery process progressed and more data became available for analysis. Additionally, we developed a cross-facilities application of an AI model that predicts the need for an unplanned cesarean delivery, illuminating the challenges associated with inter-facility variation in reporting practices. Overall, these studies combine novel technologies with currently available data to predict and assist safe deliveries for mothers and babies, both locally and globally. [ABSTRACT FROM AUTHOR]

Published
2024
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33. Normal labor curve in twin gestation

Author

Hochler, Hila, Guedalia, Joshua, Lipschuetz, Michal, Walfisch, Asnat, Yagel, Simcha, Guedalia Friedman, Efrat, Unger, Ron, Sergienko, Ruslan, Yoles, Israel, Kabiri, Doron, Cohen, Sarah M., and Sheiner, Eyal

Published
2021
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37. Assessing the Clinical Significance of Third-Trimester Post-Coital Bleeding.

Author

Kabiri, Doron, Amsalem, Hagai, Watad, Hadel, Lipschuetz, Michal, Haj-Yahya, Rani, Alter, Roie, and Ezra, Yossef

Subjects
UTERINE hemorrhage, PREGNANCY complications, PREGNANCY outcomes, PREMATURE labor, PREGNANT women, INDUCED labor (Obstetrics)
Abstract

Introduction: This study aimed to evaluate the impact of third-trimester post-coital bleeding (PCB) on pregnancy outcomes. Methods: A retrospective cohort study was conducted at two tertiary medical centers, including all pregnant women between 24 and 34 weeks of gestation referred due to vaginal bleeding over an 11-year period. The study population includes all singleton deliveries; within this population, women were further classified into three groups: those admitted due to vaginal bleeding related to PCB, those admitted due to vaginal bleeding not related to PCB, and those who did not report vaginal bleeding. The primary outcome measure was delivery prior to 37 weeks of gestation, while secondary outcome measures included maternal and neonatal complications. Baseline characteristics of the two groups were compared. Results: During the study period, there were a total of 51,698 deliveries. Among these, 230 cases involved bleeding between 24 and 34 weeks of gestation, 34 (14.8%) were identified as PCB, and 196 as bleeding unrelated to intercourse. In addition, 51,468 pregnancies without bleeding were analyzed as the general population for comparison. The incidence of preterm labor before 37 weeks of gestation was notably higher in both women with PCB (14.7%) and those with bleeding unrelated to coitus (20.9%) compared to the general population (5.6%); however, there was no statistically significant difference between the two bleeding groups (p = 0.403) while both were significantly different from the general population (p < 0.001). The odds ratio for preterm birth before 37 weeks of gestation after PCB was 3.29 (95% CI: 1.26–8.56, p = 0.0149). There were no significant differences between the PCB and bleeding unrelated to intercourse groups in terms of maternal and neonatal complications. Conclusion: This study found that third-trimester PCB is a risk factor for preterm delivery, with rates similar to other causes of third-trimester bleeding but significantly higher than the general population without bleeding. These findings challenge the assumption that PCB is benign. [ABSTRACT FROM AUTHOR]

Published
2024
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40. Boosting maternal and neonatal anti–SARS-CoV-2 humoral immunity using a third mRNA vaccine dose

Author

Cahen-Peretz, Adva, primary, Tsaitlin-Mor, Lilah, additional, Allouche Kam, Hadas, additional, Frenkel, Racheli, additional, Kabessa, Maor, additional, Cohen, Sarah M., additional, Lipschuetz, Michal, additional, Oiknine-Djian, Esther, additional, Lianski, Sapir, additional, Goldman-Wohl, Debra, additional, Walfisch, Asnat, additional, Kovo, Michal, additional, Neeman, Michal, additional, Wolf, Dana G., additional, Yagel, Simcha, additional, and Beharier, Ofer, additional

Published
2023
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46. Effectiveness of BNT162b2 mRNA COVID-19 third vaccines during pregnancy: A national observational study in Israel

Author

Guedalia, Joshua, primary, Lipschuetz, Michal, additional, Calderon-Margalit, Ronit, additional, Cohen, Sarah, additional, Goldman-Wohl, Debra, additional, Kaminer, Tali, additional, Melul, Eli, additional, Shefer, Galit, additional, Sompolinsky, Yishai, additional, Walfisch, Asnat, additional, Yagel, Simcha, additional, and Beharier, Ofer, additional

Published
2022
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48. Boosting maternal and neonatal anti SARS-CoV-2 humoral immunity using a third mRNA vaccine dose

Author

Cahen-Peretz, Adva, primary, Tsaitlin-Mor, Lilah, additional, Kam, Hadas Allouche, additional, Fraenkel, Rachelle, additional, Kabessa, Maor, additional, Cohen, Sarah, additional, Lipschuetz, Michal, additional, Oiknine-Djian, Esther, additional, Liansky, Sapir, additional, Goldman-Wohl, Debra, additional, Walfisch, Asnat, additional, Kovo, Michal, additional, Neeman, Michal, additional, Wolf, Dana, additional, Yagel, Simcha, additional, and Beharier, Ofer, additional

Published
2022
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50. Total breech extraction of the second twin in trial of labor after cesarean

Author

Hochler, Hila, primary, Tevet, Aharon, additional, Barg, Moshe, additional, Suissa-Cohen, Yael, additional, Lipschuetz, Michal, additional, Yagel, Simcha, additional, Aviram, Amir, additional, Mei-Dan, Elad, additional, Melamed, Nir, additional, Barrett, Jon, additional, Fox, Nathan S., additional, and Walfisch, Asnat, additional

Published
2022
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