ISUOG Interim Guidance on 2019 novel coronavirus infection during pregnancy and puerperium: information for healthcare professionals.

Abstract

In response to the World Health Organization (WHO) statements and international concerns regarding the novel coronavirus infection (COVID-19) outbreak, the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) is issuing the following guidance for management during pregnancy and puerperium. With the current uncertainty regarding many aspects of the clinical course of COVID-19 infection in pregnancy, potentially valuable information is likely to be obtained by obstetricians and ultrasound practitioners that may help in counseling pregnant women and further improve our understanding of the pathophysiology of COVID-19 infection in pregnancy. This statement is not intended to replace previously published interim guidance on evaluation and management of COVID-19-exposed pregnant women. It should, therefore, be considered in conjunction with other relevant advice from organizations such as: WHO: https://www.who.int/emergencies/diseases/novel-coronavirus-2019 Centers for Disease Control and Prevention (CDC): https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/pregnancy-faq.html Pan American Health Organization (PAHO): http://www.paho.org European Centre for Disease Prevention and Control (ECDC): https://www.ecdc.europa.eu Public Health England: https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public National Health Commission of the People's Republic of China: http://www.nhc.gov.cn Perinatal Medicine Branch of Chinese Medical Association: https://mp.weixin.qq.com/s/11hbxlPh317es1XtfWG2qg Indicazioni ad interim della Societa Italiana di Neonatologia (SIN): https://www.policlinico.mi.it/uploads/fom/attachments/pagine/pagine_m/79/files/allegati/539/allattamento_e_infezione_da_sars-cov-2_indicazioni_ad_interim_della_societ___italiana_di_neonatologia_sin__2_.pdf Santé Publique France https://www.santepubliquefrance.fr/ Sociedad Española de Ginecología y Obstetricia S.E.G.O.: https://mcusercontent.com/fbf1db3cf76a76d43c634a0e7/files/1abd1fa8-1a6f-409d-b622-c50e2b29eca9/RECOMENDACIONES_PARA_LA_PREVENCIO_N_DE_LA_INFECCIO_N_Y_EL_CONTROL_DE_LA_ENFERMEDAD_POR_CORONAVIRUS_2019_COVID_19_EN_LA_PACIENTE_OBSTE_TRICA.pdf Royal College of Obstetricians and Gynaecologists (RCOG): https://www.rcog.org.uk/en/guidelines-research-services/guidelines/coronavirus-pregnancy/ The novel coronavirus infection (COVID-19), also termed SARS-CoV-2, is a global public health emergency. Since the first case of COVID-19 pneumonia was reported in Wuhan, Hubei Province, China, in December 2019, the infection has spread rapidly to the rest of China and beyond1-3. Coronaviruses are enveloped, non-segmented, positive-sense ribonucleic acid (RNA) viruses belonging to the family Coronaviridae, order Nidovirales4. The epidemics of the two β-coronaviruses, severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV), have caused more than 10 000 cumulative cases in the past two decades, with mortality rates of 10% for SARS-CoV and 37% for MERS-CoV5-9. COVID-19 belongs to the same β-coronavirus subgroup and it has genome similarity of about 80% and 50% with SARS-CoV and MERS-CoV, respectively10. COVID-19 is spread by respiratory droplets and direct contact (when bodily fluids touch another person's eyes, nose or mouth, or an open cut, wound or abrasion). The Report of the World Health Organization (WHO)-China Joint Mission on Coronavirus Disease 2019 (COVID-19)11 estimated a high R0 (reproduction number) of 2–2.5. The latest report from WHO12, on March 3rd, estimated the global mortality rate of COVID-19 infection to be 3.4%. Huang et al.1 first reported on a cohort of 41 patients with laboratory-confirmed COVID-19 pneumonia. They described the epidemiological, clinical, laboratory and radiological characteristics, as well as treatment and clinical outcome of the patients. Subsequent studies with larger sample sizes have shown similar findings13, 14. The most common symptoms reported are fever (43.8% of cases on admission and 88.7% during hospitalization) and cough (67.8%)15. Diarrhea is uncommon (3.8%). On admission, ground-glass opacity is the most common radiologic finding on computed tomography (CT) of the chest (56.4%). No radiographic or CT abnormality was found in 157 of 877 (17.9%) patients with non-severe disease and in five of 173 (2.9%) patients with severe disease. Lymphocytopenia was reported to be present in 83.2% of patients on admission15. Pregnancy is a physiological state that predisposes women to respiratory complications of viral infection. Due to the physiological changes in their immune and cardiopulmonary systems, pregnant women are more likely to develop severe illness after infection with respiratory viruses. In 2009, pregnant women accounted for 1% of patients infected with influenza A subtype H1N1 virus, but they accounted for 5% of all H1N1-related deaths16. In addition, SARS-CoV and MERS-CoV are both known to be responsible for severe complications during pregnancy, including the need for endotracheal intubation, admission to an intensive care unit (ICU), renal failure and death9, 17. The case fatality rate of SARS-CoV infection among pregnant women is up to 25%9. Currently, however, there is no evidence that pregnant women are more susceptible to COVID-19 infection or that those with COVID-19 infection are more prone to developing severe pneumonia. Over and above the impact of COVID-19 infection on a pregnant woman, there are concerns relating to the potential effect on fetal and neonatal outcome; therefore, pregnant women require special attention in relation to prevention, diagnosis and management. Based on the limited information available as yet and our knowledge of other similar viral pulmonary infections, the following expert opinions are offered to guide clinical management. Case definitions are those included in the WHO's interim guidance, ‘Global surveillance for COVID-19 disease caused by human infection with the 2019 novel coronavirus’18. A suspected case for which laboratory testing for COVID-19 is inconclusive. A person with laboratory confirmation of COVID-19 infection, irrespective of clinical signs and symptoms. It is plausible that a proportion of transmissions occurs from cases with mild symptoms that do not provoke healthcare-seeking behavior. Under these circumstances, in areas in which local transmission occurs, an increasing number of cases without a defined chain of transmission is observed19 and a lower threshold for suspicion in patients with severe acute respiratory infection may be recommended by health authorities. Any suspected case should be tested for COVID-19 infection using available molecular tests, such as quantitative reverse transcription polymerase chain reaction (qRT-PCR). Lower-respiratory-tract specimens likely have a higher diagnostic value compared with upper-respiratory-tract specimens for detecting COVID-19 infection. The WHO recommends that, if possible, lower-respiratory-tract specimens, such as sputum, endotracheal aspirate or bronchoalveolar lavage, be collected for COVID-19 testing. If patients do not have signs or symptoms of lower-respiratory-tract disease or specimen collection for lower-respiratory-tract disease is clinically indicated but collection is not possible, upper-respiratory-tract specimens of combined nasopharyngeal and oropharyngeal swabs should be collected. If initial testing is negative in a patient who is strongly suspected of having COVID-19 infection, the patient should be resampled, with a sampling time interval of at least 1 day and specimens collected from multiple respiratory-tract sites (nose, sputum, endotracheal aspirate). Additional specimens, such as blood, urine and stool, may be collected to monitor the presence of virus and the shedding of virus from different body compartments. When qRT-PCR analysis is negative for two consecutive tests, COVID-19 infection can be ruled out. The WHO has provided guidance on the rational use of PPE for COVID-19. When conducting aerosol-generating procedures (e.g. tracheal intubation, non-invasive ventilation, cardiopulmonary resuscitation, manual ventilation before intubation), healthcare workers are advised to use respirators (e.g. N95, FFP2 or equivalent standard) with their PPE20, 21. CDC additionally considers procedures that are likely to induce coughing (e.g. sputum induction, collection of nasopharyngeal swabs and suctioning) as aerosol-generating procedures and CDC guidance includes the option of using a powered air-purifying respirator (PAPR). Chest imaging, especially CT scan, is essential for evaluation of the clinical condition of a pregnant woman with COVID-19 infection22-24. Fetal growth restriction (FGR), microcephaly and intellectual disability are the most common adverse effects from high-dose (> 610 mGy) radiation exposure25-27. According to data from the American College of Radiology and American College of Obstetricians and Gynecologists, when a pregnant woman undergoes a single chest X-ray examination, the radiation dose to the fetus is 0.0005–0.01 mGy, which is negligible, while the radiation dose to the fetus is 0.01–0.66 mGy from a single chest CT or CT pulmonary angiogram28-30. Chest CT scanning has high sensitivity for diagnosis of COVID-1924. In a pregnant woman with suspected COVID-19 infection, a chest CT scan may be considered as a primary tool for the detection of COVID-19 in epidemic areas24. Informed consent should be acquired (shared decision-making) and a radiation shield be applied over the gravid uterus. Suspected, probable and confirmed cases of COVID-19 infection should be managed initially by designated tertiary hospitals with effective isolation facilities and protection equipment. Suspected/probable cases should be treated in isolation and confirmed cases should be managed in a negative-pressure isolation room. A confirmed case that is critically ill should be admitted to a negative-pressure isolation room in an ICU31. Designated hospitals should set up a dedicated negative-pressure operating room and a neonatal isolation ward. All attending medical staff should don PPE (respirator, goggle, face protective shield, surgical gown and gloves) when providing care for confirmed cases of COVID-19 infection32. However, in areas with widespread local transmission of the disease, health services may be unable to provide such levels of care to all suspected, probable or confirmed cases. Pregnant women with a mild clinical presentation may not initially require hospital admission and home confinement can be considered, provided that this is possible logistically and that monitoring of the woman's condition can be ensured33. If negative-pressure isolation rooms are not available, patients should be isolated in single rooms, or grouped together once COVID-19 infection has been confirmed. For transfer of confirmed cases, the attending medical team should don PPE and keep themselves and their patient a minimum distance of 1–2 meters from any individuals without PPE. Currently, there are limited data on the impact on the fetus of maternal COVID-19 infection. It has been reported that viral pneumonia in pregnant women is associated with an increased risk of preterm birth, FGR and perinatal mortality43. Based on nationwide population-based data, it was demonstrated that pregnant women with other viral pneumonias (n = 1462) had an increased risk of preterm birth, FGR and having a newborn with low birth weight and Apgar score < 7 at 5 min, compared with those without pneumonia (n = 7310)44. In 2004, a case series of 12 pregnant women with SARS-CoV in Hong Kong, China, reported three maternal deaths, that four of seven patients who presented in the first trimester had spontaneous miscarriage, four of five patients who presented after 24 weeks had preterm birth and two mothers recovered without delivery but their ongoing pregnancies were complicated by FGR9. Pregnant women with suspected/probable COVID-19 infection, or those with confirmed infection who are asymptomatic or recovering from mild illness, should be monitored with 2–4-weekly ultrasound assessment of fetal growth and amniotic fluid volume, with umbilical artery Doppler if necessary45. At present, it is uncertain whether there is a risk of vertical mother-to-baby transmission. In a study by Chen et al.46, of nine pregnant women with COVID-19 in the third trimester, amniotic fluid, cord blood and neonatal throat-swab samples collected from six patients tested negative for COVID-19, suggesting there was no evidence of intrauterine infection caused by vertical transmission in women who developed COVID-19 pneumonia in late pregnancy. However, there are currently no data on perinatal outcome when the infection is acquired in the first and early second trimester of pregnancy, and these pregnancies should be monitored carefully after recovery. Following ultrasound examination, ensure surfaces of transducers are cleaned and disinfected according to manufacturer specifications, taking note of the recommended ‘wet time’ for wiping transducers and other surfaces with disinfection agents47. Consider using protective covers for probes and cables, especially when there are infected skin lesions or when a transvaginal scan is necessary. In the case of high infectivity, a ‘deep clean’ of the equipment is necessary. A bedside scan is preferred; if the patient needs to be scanned in the clinic, this should be done at the end of the list, as the room and equipment will subsequently require a deep clean. Reprocessing of the probes should be documented for traceability47. Fever is common in COVID-19-infected patients. Previous data have demonstrated that maternal fever in early pregnancy can cause congenital structural abnormalities involving the neural tube, heart, kidney and other organs56-59. However, a recent study60, including 80 321 pregnant women, reported that the rate of fever in early pregnancy was 10%, while the incidence of fetal malformation in this group was 3.7%. Among the 77 344 viable pregnancies with data collected at 16–29 weeks of gestation, in the 8321 pregnant women with a reported temperature > 38°C lasting 1–4 days in early pregnancy, compared to those without a fever in early pregnancy, the overall risk of fetal malformation was not increased (odds ratio = 0.99 (95% CI, 0.88–1.12))60. Previous studies have reported no evidence of congenital infection with SARS-CoV61, and currently there are no data on the risk of congenital malformation when COVID-19 infection is acquired during the first or early second trimester of pregnancy. Nonetheless, a detailed morphology scan at 18–24 weeks of gestation is indicated for pregnant women with suspected, probable or confirmed COVID-19 infection. Currently, there are no effective drugs or vaccines to prevent COVID-19. Therefore, personal protection should be considered in order to minimize the risk of contracting the virus62. This Interim Guidance was produced by: L. C. Poon, Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Hong Kong SAR H. Yang, Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing, China J. C. S. Lee, Department of Obstetrics and Gynaecology, KK Women's and Children's Hospital, Singapore J. A. Copel, Department of Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, New Haven, CT, USA T. Y. Leung, Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Hong Kong SAR Y. Zhang, Department of Obstetrics and Gynaecology, Zhongnan Hospital of Wuhan University, Wuhan, China D. Chen, Department of Obstetrics and Gynaecology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China F. Prefumo, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy This Interim Guidance should be cited as: Poon LC, Yang H, Lee JCS, Copel JA, Leung TY, Zhang Y, Chen D, Prefumo F. ISUOG Interim Guidance on 2019 novel coronavirus infection during pregnancy and puerperium: information for healthcare professionals. Ultrasound Obstet Gynecol 2020; 55: 700–708. Appendix 1 2007 Infectious Diseases Society of America/American Thoracic Society criteria for defining severe community-acquired pneumonia. Validated definition includes either one major criterion or three or more minor criteria. Appendix 2 Example of symptoms and TOCC (travel history, occupation, significant contact and cluster) checklist Droplet precautions: put a mask on the patient; single room; healthcare worker uses PPE appropriately, including a mask, upon entry to room64. Contact precautions: single room; healthcare worker uses PPE appropriately upon entry to room, including gloves and gown; use disposable equipment64. Airborne precautions: put a mask on the patient; negative-pressure isolation room; healthcare worker uses PPE appropriately upon entry to room, including wearing a fit-test-approved respirator, gloves, gown, face and eye protection; restrict susceptible healthcare workers from entering the room; use disposable equipment64.