Sources of influence on pregnant women's preferred mode of delivery in Buenos Aires, Argentina

Background: Understanding influences on women's preferred delivery mode is vital for planning interventions to reduce cesarean rates and for ensuring that women receive correct information. Our objectives were to: determine if sources of information influencing a pregnant woman's preferred delivery mode and knowledge of cesarean indications differ by sociodemographic characteristics; to conduct a factor analysis of items related to information sources influencing this preference; and to determine if knowledge differs by information sources influencing this preference or their underlying latent constructs. Methods: Data from a prospective cohort study conducted in Buenos Aires was analyzed. Healthy nulliparous women aged 18-35, at >32 weeks of gestation and with live, singleton pregnancies participated. The primary research questions were evaluated using Chi-square tests, factor analysis, logistic regression, and generalized estimating equations. Results: A total of 382 women participated in the study. Women of lower socioeconomic status were more influenced by people, magazines and TV/movies in their mode of delivery preferences, and had poorer knowledge of cesarean indications. Sources of influence for preferred delivery mode and factors derived in factor analysis were not associated with knowledge level when considered individually or together, or when adjusted for sociodemographic characteristics, or when accounting for clustering by the hospital sector (public or private). Conclusions: Higher socioeconomic status is associated with being less influenced by people and with better knowledge of indications for cesarean delivery. Knowledge of cesarean indications was not associated with the source of information about mode of delivery preferences.Fil: Amyx, Melissa Michele. University of Tulane; Estados UnidosFil: Gibbons, Luz. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Pque. Centenario. Centro de Investigaciones En Epidemiología y Salud Publica. Instituto de Efectividad Clinica y Sanitaria. Centro de Investigaciones En Epidemiología y Salud Publica.; ArgentinaFil: Xiong, Xu. University of Tulane; Estados UnidosFil: Mazzoni, Agustina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Pque. Centenario. Centro de Investigaciones En Epidemiología y Salud Publica. Instituto de Efectividad Clinica y Sanitaria. Centro de Investigaciones En Epidemiología y Salud Publica.; ArgentinaFil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Pque. Centenario. Centro de Investigaciones En Epidemiología y Salud Publica. Instituto de Efectividad Clinica y Sanitaria. Centro de Investigaciones En Epidemiología y Salud Publica.; ArgentinaFil: Buekens, Pierre. University of Tulane; Estados UnidosFil: Belizan, Jose. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Pque. Centenario. Centro de Investigaciones En Epidemiología y Salud Publica. Instituto de Efectividad Clinica y Sanitaria. Centro de Investigaciones En Epidemiología y Salud Publica.; Argentin

Women’s preferences and mode of delivery in public and private hospitals: a prospective cohort study

Background Rates of caesarean section have steadily increased in most middle- and high-income countries over the last few decades without medical justification. Maternal request is one of the frequently cited non-medical factors contributing to this trend. The objectives of this study were to assess pregnant women’s preferences regarding mode of delivery and to compare actual caesarean section rates in the public and private sectors. Methods A prospective cohort study was conducted in two public and three private hospitals in Buenos Aires, Argentina. 382 nulliparous pregnant women (183 from the private sector and 199 from the public sector) aged 18 to 35 years, with single pregnancies over 32 weeks of gestational age were enrolled during antenatal care visits between October 2010 and September 2011. We excluded women with pregnancies resulting from assisted fertility, women with known pre-existing major diseases or, with pregnancy complications, or with a medical indication of elective cesarean section. We used two different approaches to assess women’s preferences: a survey using a tailored questionnaire, and a discrete choice experiment. Results Only 8 and 6 % of the healthy nulliparous women in the public and private sectors, respectively, expressed a preference for caesarean section. Fear of pain and safety were the most frequently expressed reasons for preferring caesarean section. When reasons for delivery mode were assessed by a discrete choice experiment, women placed the most emphasis on sex after childbirth. Of women who expressed their preference for vaginal delivery, 34 and 40 % ended their pregnancies by caesarean section in public and private hospitals, respectively. Conclusions The preference for caesarean section is low among healthy nulliparous women in Buenos Aires. The reasons why these women had a rate of more than 35 % caesarean sections are unlikely related to their preferences for mode of delivery.Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Gutierrez, Laura. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Gibbons, Luz. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Liu, Nancy H.. UCSF General Internal Medicine; Estados UnidosFil: Bonotti, Ana María. Ministerio de Salud de la Nación; ArgentinaFil: Izbizky, Gustavo H.. Hospital Italiano; ArgentinaFil: Ferrary, Marta. Hospital Magdalena; ArgentinaFil: Viergue, Nora. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; ArgentinaFil: Vigil, Silvia I.. Hospital Británico de Buenos Aires; ArgentinaFil: Zalazar Denett, Gabriela. Hospital Materno Infantil Dr. Carlos Gianantonio; ArgentinaFil: Belizan, Jose. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentin

The development of the WHO Labour Care Guide: an international survey of maternity care providers

Background: The partograph is the most commonly used labour monitoring tool in the world. However, it has been used incorrectly or inconsistently in many settings. In 2018, a WHO expert group reviewed and revised the design of the partograph in light of emerging evidence, and they developed the first version of the Labour Care Guide (LCG). The objective of this study was to explore opinions of skilled health personnel on the first version of the WHO Labour Care Guide. Methods: Skilled health personnel (including obstetricians, midwives and general practitioners) of any gender from Africa, Asia, Europe and Latin America were identified through a large global research network. Country coordinators from the network invited 5 to 10 mid-level and senior skilled health personnel who had worked in labour wards anytime in the last 5 years. A self-administered, anonymous, structured, online questionnaire including closed and open-ended questions was designed to assess the clarity, relevance, appropriateness of the frequency of recording, and the completeness of the sections and variables on the LCG. Results: A total of 110 participants from 23 countries completed the survey between December 2018 and January 2019. Variables included in the LCG were generally considered clear, relevant and to have been recorded at the appropriate frequency. Most sections of the LCG were considered complete. Participants agreed or strongly agreed with the overall design, structure of the LCG, and the usefulness of reference thresholds to trigger further assessment and actions. They also agreed that LCG could potentially have a positive impact on clinical decision-making and respectful maternity care. Participants disagreed with the value of some variables, including coping, urine, and neonatal status. Conclusions: Future end-users of WHO Labour Care Guide considered the variables to be clear, relevant and appropriate, and, with minor improvements, to have the potential to positively impact clinical decision-making and respectful maternity care.Fil: Pingray, María Verónica. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Bonetto, Mercedes. Organizacion Mundial de la Salud; ArgentinaFil: Berrueta, Amanda Mabel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Belizán, María. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Keil, Netanya. Nyu Abu Dhabi; Emiratos Arabes UnidosFil: Vogel, Joshua. Burnet Institute; AustraliaFil: Althabe, Fernando. Organizacion Mundial de la Salud; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Oladapo, Olufemi T.. Organizacion Mundial de la Salud; Argentin

Smoking Patterns and Receipt of Cessation Services Among Pregnant Women in Argentina and Uruguay

Introduction: The 5A’s (Ask, Advise, Assess, Assist, and Arrange) strategy, a best-practice approach for cessation counseling, has been widely implemented in high-income countries for pregnant women; however, no studies have evaluated implementation in middle-income countries. The study objectives were to assess smoking patterns and receipt of 5A’s among pregnant women in Buenos Aires, Argentina and Montevideo, Uruguay. Methods: Data were collected through administered questionnaires to women at delivery hospitalizations during October 2011–May 2012. Eligible women attended one of 12 maternity hospitals or 21 associated prenatal care clinics. The questionnaire included demographic data, tobacco use/cessation behaviors, and receipt of the 5A’s. Self-reported cessation was verified with saliva cotinine. Results: Overall, of 3400 pregnant women, 32.8% smoked at the beginning of pregnancy; 11.9% quit upon learning they were pregnant or later during pregnancy, and 20.9% smoked throughout pregnancy. Smoking prevalence varied by country with 16.1% and 26.7% who smoked throughout pregnancy in Argentina and Uruguay, respectively. Among pregnant smokers in Argentina, 23.8% reported that a provider asked them about smoking at more than one prenatal care visit; 18.5% were advised to quit; 5.3% were assessed for readiness to quit, 4.7% were provided assistance, and 0.7% reported follow-up was arranged. In Uruguay, those percentages were 36.3%, 27.9%, 5.4%, 5.6%, and 0.2%, respectively. Conclusions: Approximately, one in six pregnant women smoked throughout pregnancy in Buenos Aires and one in four in Montevideo. However, a low percentage of smokers received any cessation assistance in both countries. Healthcare providers are not fully implementing the recommended 5A’s intervention to help pregnant women quit smoking.Fil: Berrueta, Amanda Mabel. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Morello, Paola. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Alemán, Alicia. Unidad de Investigación Clínica y Epidemiológica Montevideo; UruguayFil: Tong, Van T.. Centers for Disease Control and Prevention; Estados UnidosFil: Johnson, Carolyn. Tulane School of Public Health and Tropical Medicine; Estados UnidosFil: Dietz, Patricia M.. Centers for Disease Control and Prevention; Estados UnidosFil: Farr, Sherry L.. Centers for Disease Control and Prevention; Estados UnidosFil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Colomar, Mercedes. Unidad de Investigación Clínica y Epidemiológica Montevideo; UruguayFil: Ciganda, Alvaro. Unidad de Investigación Clínica y Epidemiológica Montevideo; UruguayFil: Llambi, Laura. Unidad de Investigación Clínica y Epidemiológica Montevideo; UruguayFil: Becú, Ana. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Gibbons, Luz. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Smith, Ruben A.. Centers for Disease Control and Prevention; Estados UnidosFil: Buekens, Pierre. Tulane School of Public Health and Tropical Medicine; Estados UnidosFil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentin

Do Italian women prefer cesarean section? Results from a survey on mode of delivery preferences

Background: About 20 million cesareans occur each year in the world and rates have steadily increased in almost all middle- and high-income countries over the last decades. Maternal request is often argued as one of the key forces driving this increase. Italy has the highest cesarean rate of Europe, yet there are no national surveys on the views of Italian women about their preferences on route of delivery. This study aimed to assess Italian women's preference for mode of delivery, as well as reasons and factors associated with this preference, in a nationally representative sample of women.Methods: This cross sectional survey was conducted between December 2010-March 2011. An anonymous structured questionnaire asked participants what was their preferred mode of delivery and explored the reasons for this preference by assessing their agreement to a series of statements. Participants were also asked to what extent their preference was influenced by a series of possible sources. the 1st phase of the study was carried out among readers of a popular Italian women's magazine (Io Donna). in a 2nd phase, the study was complemented by a structured telephone interview.Results: A total of 1000 Italian women participated in the survey and 80% declared they would prefer to deliver vaginally if they could opt. the preference for vaginal delivery was significantly higher among older (84.7%), more educated (87.6%), multiparous women (82.3%) and especially among those without any previous cesareans (94.2%). the main reasons for preferring a vaginal delivery were not wanting to be separated from the baby during the first hours of life, a shorter hospital stay and a faster postpartum recovery. the main reasons for preferring a cesarean were fear of pain, convenience to schedule the delivery and because it was perceived as being less traumatic for the baby. the source which most influenced the preference of these Italian women was their obstetrician, followed by friends or relatives.Conclusion: Four in five Italian women would prefer to deliver vaginally if they could opt. Factors associated with a higher preference for cesarean delivery were youth, nulliparity, lower education and a previous cesarean.Universidade Federal de São Paulo, Dept Obstet, São Paulo, BrazilWHO, Dept Reprod Hlth & Res, CH-1211 Geneva, SwitzerlandOsservatorio Nazl Salute Donna, ONDa, Milan, ItalyInst Clin Effectiveness & Hlth Policy, Buenos Aires, DF, ArgentinaUniv Florence, Meyer Children Hosp, I-50121 Florence, ItalyUniversidade Federal de São Paulo, Dept Obstet, São Paulo, BrazilWeb of Scienc

COVID-19 and pregnancy: An umbrella review of clinical presentation, vertical transmission, and maternal and perinatal outcomes

Background We conducted an overview of systematic reviews (SRs) summarizing the best evidence regarding the effect of COVID-19 on maternal and child health following Cochrane methods and PRISMA statement for reporting (PROSPERO-CRD42020208783). Methods We searched literature databases and COVID-19 research websites from January to October 2020. We selected relevant SRs reporting adequate search strategy, data synthesis, risk of bias assessment, and/or individual description of included studies describing COVID-19 and pregnancy outcomes. Pair of reviewers independently selected studies through COVIDENCE web-software, performed the data extraction, and assessed its quality through the AMSTAR-2 tool. Discrepancies were resolved by consensus. Each SR’s results were synthesized and for the most recent, relevant, comprehensive, and with the highest quality, by predefined criteria, we presented GRADE evidence tables. Results We included 66 SRs of observational studies out of 608 references retrieved and most (61/66) had "critically low" overall quality. We found a relatively low degree of primary study overlap across SRs. The most frequent COVID-19 clinical findings during pregnancy were fever (28–100%), mild respiratory symptoms (20–79%), raised C-reactive protein (28–96%), lymphopenia (34–80%), and pneumonia signs in diagnostic imaging (7–99%). The most frequent maternal outcomes were C-section (23–96%) and preterm delivery (14–64%). Most of their babies were asymptomatic (16–93%) or presented fever (0–50%), low birth weight (5–43%) or preterm delivery (2–69%). The odds ratio (OR) of receiving invasive ventilation for COVID-19 versus non-COVID-19 pregnant women was 1.88 (95% Confidence Interval [CI] 1.36–2.60) and the OR that their babies were admitted to neonatal intensive care unit was 3.13 (95%CI 2.05–4.78). The risk of congenital transmission or via breast milk was estimated to be low, but close contacts may carry risks. Conclusion This comprehensive overview supports that pregnant women with COVID-19 may be at increased risk of adverse pregnancy and birth outcomes and low risk of congenital transmission.Fil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Bardach, Ariel Esteban. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Comandé, Daniel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Berrueta, Mabel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Argento, Fernando J.. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Rodriguez Cairoli, Federico. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Zamora, Natalia. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Santa María, Victoria. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Xiong, Xu. University of Tulane; Estados UnidosFil: Zaraa, Sabra. University of Washington; Estados UnidosFil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Buekens, Pierre. University of Tulane; Estados Unido

Ecografía para prevenir lesiones del nervio sural en la reparación del tendón de Aquiles. Estudio cadavérico

Introducción: Las técnicas mínimamente invasivas son las preferidas para tratar las roturas agudas del tendón de Aquiles. Representan una opción para evitar las complicaciones tegumentarias, y la lesión del nervio sural es uno de sus principales problemas. El objetivo de este estudio fue comprobar la utilidad de la ecografía para prevenir la lesión del nervio sural durante la reparación del tendón de Aquiles con técnicas percutáneas. Materiales y Métodos: Estudio en 12 piezas cadavéricas. Se recreó una lesión en el tendón de Aquiles 5 cm proximales de su inserción distal. En uno de los miembros del cadáver, se identificó el nervio sural o su vena satélite mediante ecografía. Se reparó el nervio sural por vía percutánea con dos agujas proximales y dos agujas distales a la lesión, y se representó el recorrido del nervio sural. En el miembro contralateral, no se identificó el nervio sural mediante ecografía. Se efectuó la reparación percutánea de las lesiones mediante la técnica de Ma y Griffith. Resultados: En el grupo ecográfico, no se identificaron lesiones del nervio sural. En el grupo de control, se observaron dos lesiones del nervio sural (p = 0,6). En todos los casos, la identificación del nervio sural mediante ecografía fue correcta. Conclusión: La asistencia ecográfica en el tratamiento percutáneo de las lesiones del tendón de Aquiles es un método eficaz y confiable para evitar las lesiones del nervio sural

A Color-Coded Tape for Uterine Height Measurement: A Tool to Identify Preterm Pregnancies in Low Resource Settings

Introduction Neonatal mortality associated with preterm birth can be reduced with antenatal corticosteroids (ACS), yet <10% of eligible pregnant women in low-middle income countries. The inability to accurately determine gestational age (GA) leads to under-identification of high-risk women who could receive ACS or other interventions. To facilitate better identification in low-resource settings, we developed a color-coded tape for uterine height (UH) measurement and estimated its accuracy identifying preterm pregnancies. Methods We designed a series of colored-coded tapes with segments corresponding to UH measurements for 20–23.6 weeks, 24.0–35.6 weeks, and >36.0 weeks GA. In phase 1, UH measurements were collected prospectively in the Democratic Republic of Congo, India and Pakistan, using distinct tapes to address variation across regions and ethnicities. In phase 2, we tested accuracy in 250 pregnant women with known GA from early ultrasound enrolled at prenatal clinics in Argentina, India, Pakistan and Zambia. Providers masked to the ultrasound GA measured UH. Receiver operating characteristics (ROC) analysis was conducted. Results 1,029 pregnant women were enrolled. In all countries the tapes were most effective identifying pregnancies between 20.0–35.6 weeks, compared to the other GAs. The ROC areas under the curves and 95% confidence intervals were: Argentina 0.69 (0.63, 0.74); Zambia 0.72 (0.66, 0.78), India 0.84 (0.80, 0.89), and Pakistan 0.83 (0.78, 0.87). The sensitivity and specificity (and 95% confidence intervals) for identifying pregnancies between 20.0–35.6 weeks, respectively, were: Argentina 87% (82%–92%) and 51% (42%–61%); Zambia 91% (86%–95%) and 50% (40%–60%); India 78% (71%–85%) and 89% (83%–94%); Pakistan 63% (55%–70%) and 94% (89%–99%). Conclusions We observed moderate-good accuracy identifying pregnancies ≤35.6 weeks gestation, with potential usefulness at the community level in low-middle income countries to facilitate the preterm identification and interventions to reduce preterm neonatal mortality. Further research is needed to validate these findings on a population basis

A multifaceted intervention to improve syphilis screening and treatment in pregnant women in Kinshasa, Democratic Republic of the Congo and in Lusaka, Zambia: a cluster randomised controlled trial

Background: Despite international recommendations, coverage of syphilis testing in pregnant women and treatment of those found seropositive remains limited in sub-Saharan Africa. We assessed whether combining the provision of supplies with a behavioural intervention was more effective than providing supplies only, to improve syphilis screening and treatment during antenatal care. Methods: In this 18-month, cluster randomised controlled trial, we randomly assigned (1:1) 26 urban antenatal care clinics in Kinshasa, Democratic Republic of the Congo, and Lusaka, Zambia, to receive a behavioural intervention (opinion leader selection, academic detailing visits, reminders, audits and feedback, and supportive supervision) plus supplies for syphilis testing and treatment (intervention group) or to receive supplies only (control group). The primary outcomes were proportion of pregnant women who had syphilis screening out of the total who attended the clinic; and the proportion of women who had treatment with benzathine benzylpenicillin out of those who tested positive for syphilis at their first antenatal care visit. This trial is registered at ClinicalTrials.gov, number NCT02353117. Findings: The 18-month study period was Feb 1, 2016, to July 14, 2017. 18 357 women were enrolled at the 13 intervention clinics and 17 679 women were enrolled at the 13 control clinics at their first antenatal care visit. Syphilis screening was done in a median of 99·9% (IQR 99·0–100·0) of women in the intervention clinics and 93·8% (85·0–98·9) in the control clinics (absolute difference 6·1% [95% CI 1·1–14·1]; p=0·00092). Syphilis treatment at the first visit was done in a median of 100% (IQR 99·7–100·0) of seropositive women in intervention clinics and 43·2% (2·6–83·2) of seropositive women in control clinics (absolute difference 56·8% [12·8–99·0]; p=0·0028). Interpretation: A behavioural intervention, together with the provision of supplies, can lead to more than 95% of women being screened and treated for syphilis. The sole provision of supplies is sufficient to reach such levels of screening coverage but is not sufficient to ensure high levels of treatment. Funding: Bill & Melinda Gates Foundation.Fil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina. Organizacion Mundial de la Salud; ArgentinaFil: Chomba, Elwyn. University Teaching Hospital of Lusaka; ZambiaFil: Tshefu, Antoinette K. University of Kinshasa; República Democrática del CongoFil: Banda, Ernest. University Teaching Hospital of Lusaka; ZambiaFil: Belizán, María Melina Eleonora. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Bergel, Eduardo. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Berrueta, Amanda Mabel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Bertrand, Jane. University of Tulane; Estados UnidosFil: Bose, Carl. University of North Carolina; Estados UnidosFil: Cafferata, Maria Luisa. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Carlo, Waldemar A. University of Alabama at Birmingahm; Estados UnidosFil: Ciganda, Alvaro. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Donnay, France. University of Tulane; Estados UnidosFil: Garcia Elorrio, Ezequiel. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Gibbons, Luz. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Klein, Karen. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Liljestrand, Jerker. Bill And Melinda Gates Foundation; Estados UnidosFil: Lusamba, Paul D. University of Kinshasa; República Democrática del CongoFil: Mavila, Arlette K. University of Kinshasa; República Democrática del CongoFil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Nkamba, Dalau M. University of Kinshasa; República Democrática del CongoFil: Mwanakalanga, Friday H. University Teaching Hospital Lusaka; ZambiaFil: Mwapule Tembo, Abigail. University Teaching Hospital Lusaka; ZambiaFil: Mwenechanya, Musaku. University Teaching Hospital Lusaka; ZambiaFil: Pyne Mercier, Lee. Bill And Melinda Gates Foundation; Estados UnidosFil: Spira, Cintia. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Wetshikoy, Jean D. University of Kinshasa; República Democrática del CongoFil: Xiong, Xu. University of Tulane; Estados UnidosFil: Buekens, Pierre. University of Tulane; Estados Unido

Safety of COVID-19 vaccines, their components or their platforms for pregnant women: A rapid review.

BACKGROUND: Pregnant women with COVID-19 are at an increased risk of severe COVID-19 illness as well as adverse pregnancy and birth outcomes. Many countries are vaccinating or considering vaccinating pregnant women with limited available data about the safety of this strategy. Early identification of safety concerns of COVID-19 vaccines, including their components, or their technological platforms is therefore urgently needed. METHODS: We conducted a rapid systematic review, as the first phase of an ongoing full systematic review, to evaluate the safety of COVID-19 vaccines in pregnant women, including their components, and their technological platforms (whole virus, protein, viral vector or nucleic acid) used in other vaccines, following the Cochrane methods and the PRISMA statement for reporting (PROSPERO-CRD42021234185).We searched literature databases, COVID-19 and pregnancy registries from inception February 2021 without time or language restriction and explored the reference lists of relevant systematic reviews retrieved. We selected studies of any methodological design that included at least 50 pregnant women or pregnant animals exposed to the vaccines that were selected for review by the COVAX MIWG in August 2020 or their components or platforms included in the COVID-19 vaccines, and evaluated adverse events during pregnancy and the neonatal period.Pairs of reviewers independently selected studies through the COVIDENCE web software and performed the data extraction through a previously piloted online extraction form. Discrepancies were resolved by consensus. RESULTS: We identified 6768 records, 256 potentially eligible studies were assessed by full-text, and 37 clinical and non-clinical studies (38 reports, involving 2,397,715 pregnant women and 56 pregnant animals) and 12 pregnancy registries were included.Most studies (89%) were conducted in high-income countries. The most frequent study design was cohort studies (n=21), followed by surveillance studies, randomized controlled trials, and registry analyses. Most studies (76%) allowed comparisons between vaccinated and unvaccinated pregnant women (n=25) or animals (n=3) and reported exposures during the three trimesters of pregnancy.The most frequent exposure was to AS03 adjuvant in the context of A/H1N1 pandemic influenza vaccines (n=24), followed by aluminum-based adjuvants (n=11). Aluminum phosphate was used in Respiratory Syncytial Virus Fusion candidate vaccines (n=3) and Tdap vaccines (n=3). Different aluminum-based adjuvants were used in hepatitis vaccines. The replication-deficient simian adenovirus ChAdOx1 was used for a Rift Valley fever vaccine. Only one study reported exposure to messenger RNA (mRNA) COVID-19 vaccines that also used lipid nanoparticles. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03) - corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns. CONCLUSION: This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines that were selected for review by the COVAX MIWG or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted given their novelty. Our findings support current WHO guidelines recommending that pregnant women may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease