Efficacy and safety of therapies for COVID-19 in pregnancy: a systematic review and meta-analysis
Abstract Background Clinical evidence suggests that pregnant women are more vulnerable to COVID-19, since they are at increased risk for disease progression and for obstetric complications, such as premature labor, miscarriage, preeclampsia, cesarean delivery, fetal growth restriction and perinatal...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | BMC Infectious Diseases |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12879-023-08747-2 |
| _version_ | 1797630402934865920 |
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| author | Francesco Di Gennaro Giacomo Guido Luisa Frallonardo Francesco Vladimiro Segala Rosalba De Nola Gianluca Raffaello Damiani Elda De Vita Valentina Totaro Mario Barbagallo Emanuele Nicastri Antonella Vimercati Ettore Cicinelli Giuseppina Liuzzi Nicola Veronese Annalisa Saracino |
| author_facet | Francesco Di Gennaro Giacomo Guido Luisa Frallonardo Francesco Vladimiro Segala Rosalba De Nola Gianluca Raffaello Damiani Elda De Vita Valentina Totaro Mario Barbagallo Emanuele Nicastri Antonella Vimercati Ettore Cicinelli Giuseppina Liuzzi Nicola Veronese Annalisa Saracino |
| author_sort | Francesco Di Gennaro |
| collection | DOAJ |
| description | Abstract Background Clinical evidence suggests that pregnant women are more vulnerable to COVID-19, since they are at increased risk for disease progression and for obstetric complications, such as premature labor, miscarriage, preeclampsia, cesarean delivery, fetal growth restriction and perinatal death. Despite this evidence, pregnant women are often excluded from clinical trials, resulting in limited knowledge on COVID-19 management. The aim of this systematic review and meta-analysis is to provide better evidence on the efficacy and safety of available COVID-19 treatment in pregnant women. Methods Four authors searched major electronic databases from inception until 1 st November-2022 for controlled trials/observational studies, investigating outcomes after the administration of anti-SARS-CoV-2 treatments in pregnant women affected by COVID-19. The analyses investigated the cumulative incidence of delivery and maternal outcomes in pregnant women, comparing those taking active medication vs standard care. Risk ratios (RRs) with 95% confidence intervals were calculated. Statistical significance was assessed using the random effects model and inverse-variance method. This systematic review and meta-analysis was conducted in accordance with the updated 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol has been registered in Prospero (number registration: CRD42023397445). Results From initially 937 non duplicate records, we assessed the full texts of 40 articles, finally including ten studies. In six studies, including 1627 patients, the use of casirivimab/imdevimab (CAS/IMD), remdesivir, and IFN-alpha 2b significantly decreased the need of cesarean section ((RR = 0.665; 95%CI: 0.491–0.899; p = 0.008; I 2 = 19.5%;) (Table 1, (Fig. 1). Treatments did not decrease the risk of preterm delivery, admission to neonatal ICU, or stillbirth/perinatal loss (p-values > 0.50 for all these outcomes) and did not prevent the progression of disease towards severe degrees (k = 8; 2,374 pregnant women; RR = 0.778; 95%CI: 0.550–1.099; p = 0.15; I 2 = 0%). Moreover, the use of medications during pregnancy did not modify the incidence of maternal death in two studies (Table 2). Conclusions To our analysis, CAS/IMD, remdesivir, and IFN alpha 2b reduced the number of cesarean sections but demonstrated no effect on disease progression and other obstetric and COVID-19 related outcomes. The inability to evaluate the influence of viral load on illness development in pregnant women was attributed to lack of data. In our systematic review, no major side effects were reported. Though, it is essential for the medical community to focus more on clinical trials and less on episodic case reports and case series, with standardization of fetal and maternal outcomes. |
| first_indexed | 2024-03-11T11:07:45Z |
| format | Article |
| id | doaj.art-ae44b6f0510c428baffe250846909e39 |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-03-11T11:07:45Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-ae44b6f0510c428baffe250846909e392023-11-12T12:07:40ZengBMCBMC Infectious Diseases1471-23342023-11-012311910.1186/s12879-023-08747-2Efficacy and safety of therapies for COVID-19 in pregnancy: a systematic review and meta-analysisFrancesco Di Gennaro0Giacomo Guido1Luisa Frallonardo2Francesco Vladimiro Segala3Rosalba De Nola4Gianluca Raffaello Damiani5Elda De Vita6Valentina Totaro7Mario Barbagallo8Emanuele Nicastri9Antonella Vimercati10Ettore Cicinelli11Giuseppina Liuzzi12Nicola Veronese13Annalisa Saracino14Clinic of Infectious Diseases, Department of Precision and Regenerative Medicine and Ionian Area - (DiMePRe-J), University of “Aldo Moro”, University of Bari “Aldo Moro”Clinic of Infectious Diseases, Department of Precision and Regenerative Medicine and Ionian Area - (DiMePRe-J), University of “Aldo Moro”, University of Bari “Aldo Moro”Clinic of Infectious Diseases, Department of Precision and Regenerative Medicine and Ionian Area - (DiMePRe-J), University of “Aldo Moro”, University of Bari “Aldo Moro”Clinic of Infectious Diseases, Department of Precision and Regenerative Medicine and Ionian Area - (DiMePRe-J), University of “Aldo Moro”, University of Bari “Aldo Moro”Clinic of Obstetrics & Gynaecology, University of Bari “Aldo Moro”Clinic of Obstetrics & Gynaecology, University of Bari “Aldo Moro”Clinic of Infectious Diseases, Department of Precision and Regenerative Medicine and Ionian Area - (DiMePRe-J), University of “Aldo Moro”, University of Bari “Aldo Moro”Clinic of Infectious Diseases, Department of Precision and Regenerative Medicine and Ionian Area - (DiMePRe-J), University of “Aldo Moro”, University of Bari “Aldo Moro”Geriatrics Section, Department of Internal Medicine, University of PalermoNational Institute for Infectious Diseases ‘Lazzaro Spallanzani’ (IRCCS)Clinic of Obstetrics & Gynaecology, University of Bari “Aldo Moro”Clinic of Obstetrics & Gynaecology, University of Bari “Aldo Moro”National Institute for Infectious Diseases ‘Lazzaro Spallanzani’ (IRCCS)Geriatrics Section, Department of Internal Medicine, University of PalermoClinic of Infectious Diseases, Department of Precision and Regenerative Medicine and Ionian Area - (DiMePRe-J), University of “Aldo Moro”, University of Bari “Aldo Moro”Abstract Background Clinical evidence suggests that pregnant women are more vulnerable to COVID-19, since they are at increased risk for disease progression and for obstetric complications, such as premature labor, miscarriage, preeclampsia, cesarean delivery, fetal growth restriction and perinatal death. Despite this evidence, pregnant women are often excluded from clinical trials, resulting in limited knowledge on COVID-19 management. The aim of this systematic review and meta-analysis is to provide better evidence on the efficacy and safety of available COVID-19 treatment in pregnant women. Methods Four authors searched major electronic databases from inception until 1 st November-2022 for controlled trials/observational studies, investigating outcomes after the administration of anti-SARS-CoV-2 treatments in pregnant women affected by COVID-19. The analyses investigated the cumulative incidence of delivery and maternal outcomes in pregnant women, comparing those taking active medication vs standard care. Risk ratios (RRs) with 95% confidence intervals were calculated. Statistical significance was assessed using the random effects model and inverse-variance method. This systematic review and meta-analysis was conducted in accordance with the updated 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol has been registered in Prospero (number registration: CRD42023397445). Results From initially 937 non duplicate records, we assessed the full texts of 40 articles, finally including ten studies. In six studies, including 1627 patients, the use of casirivimab/imdevimab (CAS/IMD), remdesivir, and IFN-alpha 2b significantly decreased the need of cesarean section ((RR = 0.665; 95%CI: 0.491–0.899; p = 0.008; I 2 = 19.5%;) (Table 1, (Fig. 1). Treatments did not decrease the risk of preterm delivery, admission to neonatal ICU, or stillbirth/perinatal loss (p-values > 0.50 for all these outcomes) and did not prevent the progression of disease towards severe degrees (k = 8; 2,374 pregnant women; RR = 0.778; 95%CI: 0.550–1.099; p = 0.15; I 2 = 0%). Moreover, the use of medications during pregnancy did not modify the incidence of maternal death in two studies (Table 2). Conclusions To our analysis, CAS/IMD, remdesivir, and IFN alpha 2b reduced the number of cesarean sections but demonstrated no effect on disease progression and other obstetric and COVID-19 related outcomes. The inability to evaluate the influence of viral load on illness development in pregnant women was attributed to lack of data. In our systematic review, no major side effects were reported. Though, it is essential for the medical community to focus more on clinical trials and less on episodic case reports and case series, with standardization of fetal and maternal outcomes.https://doi.org/10.1186/s12879-023-08747-2COVID-19PregnancySARS-CoV-2Monoclonal antibodiesAntiviralsMaternal morbidity |
| spellingShingle | Francesco Di Gennaro Giacomo Guido Luisa Frallonardo Francesco Vladimiro Segala Rosalba De Nola Gianluca Raffaello Damiani Elda De Vita Valentina Totaro Mario Barbagallo Emanuele Nicastri Antonella Vimercati Ettore Cicinelli Giuseppina Liuzzi Nicola Veronese Annalisa Saracino Efficacy and safety of therapies for COVID-19 in pregnancy: a systematic review and meta-analysis BMC Infectious Diseases COVID-19 Pregnancy SARS-CoV-2 Monoclonal antibodies Antivirals Maternal morbidity |
| title | Efficacy and safety of therapies for COVID-19 in pregnancy: a systematic review and meta-analysis |
| title_full | Efficacy and safety of therapies for COVID-19 in pregnancy: a systematic review and meta-analysis |
| title_fullStr | Efficacy and safety of therapies for COVID-19 in pregnancy: a systematic review and meta-analysis |
| title_full_unstemmed | Efficacy and safety of therapies for COVID-19 in pregnancy: a systematic review and meta-analysis |
| title_short | Efficacy and safety of therapies for COVID-19 in pregnancy: a systematic review and meta-analysis |
| title_sort | efficacy and safety of therapies for covid 19 in pregnancy a systematic review and meta analysis |
| topic | COVID-19 Pregnancy SARS-CoV-2 Monoclonal antibodies Antivirals Maternal morbidity |
| url | https://doi.org/10.1186/s12879-023-08747-2 |
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