Decision No. 1271/QD-BYT 2020 temporary guidance for treatment of COVID-19 in pregnant women and newborns

DECISION

Promulgating the temporary Guidance for the prevention and treatment of acute respiratory infections caused by the SARS-CoV-2 virus (COVID-19) in pregnant women and newborns

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THE MINISTER OF HEALTH

Pursuant to the Government s Decree No. 75/2017/ND-CP dated June 20, 2017 on defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Department of Children - Mother Health, Ministry of Health,

DECIDES:

Article 1.To issue together with this Decision the temporary Guidance for the prevention and treatment of acute respiratory infections caused by the SARS-CoV-2 Virus (COVID-19) in pregnant women and newborns.

Article 2.This Decision takes effect on the date of its signing.

Article 3.Mr./Ms.: The Chief of Ministry office; the Chief of Inspectorate of Ministry; Directors and General Directors of Departments and Directorates of the Ministry of Health; Directors of hospitals of the Ministry of Health; Directors of Health Departments; Heads of medical units of ministries and branches; Heads of relevant units are responsible for the implementation of this Decision./.

TEMPORARY GUIDANCE

For the prevention and treatment of acute respiratory infections caused by the SARS-CoV-2 Virus (COVID-19) in pregnant women and newborns
Attached to the Decision No. 1271/QD-BYT dated March 21, 2020 of the Minister of Health

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1. Conspectus

1.1. Virus

Coronavirus (CoV) is a large family of viruses in animals and humans. Coronavirus is divided into 4 varieties, including 2 alpha and 2 beta strains that cause disease in humans, with symptoms ranging from common flu to more serious cases such as severe acute respiratory infection syndrome SARS-CoV and Middle East respiratory syndrome (MERS-CoV), causing severe pneumonia that can be fatal.

Coronavirus is spherical with diameters of about 125 nm, with surface proteins emerging as spines. The virus contains four main structural proteins. These are the spike (S), membrane (M), envelope (E), and nucleocapsid (N) proteins. Within the envelope of the virion is a single-stranded, symmetric spiral nucleocapsid. The Coronavirus has the single-stranded and unbroken RNA genomes, of about 30 kilobase (kb).

1.2. Transmission

SARS-COV-2 is a new strain of Coronavirus that causes COVID-19 pandemic, identified for the first time in Wuhan City, China. This strain of virus can be transmitted from animals to humans and directly from person to person through droplets, respiratory tract and close contact.

For pregnant women, according to experts, there is no scientific basis to confirm that the fetus is capable of transmitting the SARS-COV-2 virus through the placenta during pregnancy. According to the recent studies of author Chen and colleagues published in early 2020, when testing amniotic fluid, umbilical cord blood, placenta, vaginal fluids and breast milk of women infected with COVID-19, the results were negative for SARS-COV-2 virus. The results of a pharyngeal test in babies born to mothers infected with COVID-19 also give a negative result for this virus.

1.3. The effects of COVID-19 on pregnant women and their unborn babies

As with other subjects, the majority of pregnant women infected with COVID-19 have mild or moderate clinical manifestations (upper respiratory tract infection or mild pneumonia), with very few serious illnesses. Only one case has been reported so far is a 30-week-old pregnant woman with severe COVID-19 infection with mechanical ventilation who had undergone an emergency cesarean section and recovered well.

For the fetus, the recent researches about COVID-19 as well as the previous researches about SARS-CoV and MERS-CoV diseases show that there is no evidence to prove a link between these diseases and the miscarriage. There is no scientific basis for the relationship between COVID-19 in pregnant women and the fetus s infection in intrauterine or fetus having congenital malformations due to the SARS-COV-2 virus. However, there is also evidence to prove that pneumonia due to virus in pregnant women is related to an increased risk of preterm birth, delayed fetal development and perinatal death, etc.

2. Prevention and control of infection

2.1. Health establishments providing obstetric and newborn care services:

- To prepare human resources, infrastructure, facilities, medical equipment and supplies to perform the principles of preventions and measures to control the transmission in the health establishments in accordance with current regulations of the Ministry of Health.

- To ensure adequate means for prevention, especially personal protective clothing, hand sanitizer, and medical masks.

- Ramification requirements:

+ To organize a screening, early detection and control of infected or suspected COVID-19 patients at reception.

+ To arrange separate areas to receive, screen and separate pregnant women that go for medical examination. If there is any suspected sign, they shall be transferred to the quarantine area for medical examination.

+ To perform routine antenatal check-ups and coordinate with preventive health facilities to take samples for testing and diagnosis for suspected cases of COVID-19 infection.

+ To arrange a separate room for suspected and infected pregnant women.

- Health establishments are required to implement the “Investigation, supervision and report of infected cases” in accordance with the Guidance on the diagnosis and treatment of the acute pneumonia caused by new a strain of Coronavirus attached to the Decision No. 322/QD-BYT dated February 06, 2020 of the Minister of Health.

- Health establishments need to arrange separately caregivers for people infected or suspected to be infected with COVID-19. In the process of taking care of people infected or suspected to be infected with COVID-19, such medical staff should not take care of other patients.

2.2. Pregnant women and postpartum mothers coming for medical examination (patients):

- To guide patients and their relatives to wear medical masks and go to the quarantine areas.

- To keep a distance of at least 2m between each patient.

- To guide patients to cover their noses and mouths when coughing and sneezing and wash their hands immediately after touch the respiratory fluids.

- To restrict the movement of patients in medical facilities.

- Relatives of people infected or suspected to be infected with COVID-19 should be considered as exposed to COVID-19 and must also be screened until the end of the prescribed follow-up period for the early diagnosis and prevention of COVID-19.

2.3. Medical staffs:To comply with the standard preventive and transmission-based prevention practices, apply measures to prevent droplets, contact precautions and airborne transmission in accordance with current regulations of the Ministry of Health.

3. Treatment for a pregnant woman infected or suspected to be infected with COVID-19

3.1. Early diagnosis and detection of people infected or suspected to be infected with COVID-19:To comply with the Decision No. 322/QD-BYT dated February 06, 2020 of the Minister of Health on promulgating the Guidance on the diagnosis and treatment of the acute pneumonia caused by new a strain of Coronavirus and relevant guidance of the Ministry of Health.

3.2. Treatment

3.2.1. Treatment principles

- Priority is given to internal medical treatment first.

- Clinical classification and treatment in accordance with the Decision No. 322/QD-BYT dated February 06, 2020 of the Minister of Health on promulgating the Guidance on the diagnosis and treatment of the acute pneumonia caused by new a strain of Coronavirus.

- To limit obstetric interventions during the COVID-19 suspected/ infected period, unless indicated emergency intervention (placenta praevia/ accreta increta percreta with heavy bleeding, abruptio placentae, fetal failure, etc.) or subacute (rupture of membranes, delivery, etc.).

- To consider the benefits between mother and fetus.

3.2.2. Treatment for a pregnant woman infected or suspected to be infected with COVID-19

a. Prenatal care:

- To carry out prenatal care according to the National guidance on reproductive health care services issued in the Decision No. 4128/QD-BYT dated July 29, 2016 of the Minister of Health.

- Measures to prevent COVID-19 infection shall be consulted when carrying out the prenatal care.

- If a pregnant woman infected or suspected to be infected with COVID-19 should have a diagnostic test as soon as possible; and the COVID-19 diagnostic assay cannot be tested, it is required to contact the testing facility authorized by the Ministry of Health.

b. Treatment for a pregnant woman that:

- Suspected to be infected with COVID-19:

+ To transfer her to the concentrated quarantine establishment of area and carry out the isolation in accordance with current regulations of the Ministry of Health.

+ To transfer her to the local health facility that in charge of treatment of COVID-19 if the COVID-19 testing result is positive.

+ To transfer her to an obstetric facility if there is any abnormal sign or any signs of delivery.

- Infected with COVID-19:

+ To give priority for treatment of COVID-19 first, obstetric intervention only when there is an emergency obstetric symptom or when the mother s condition is bad need specialist consultation involved.

+ A pregnant woman infected with COVID-19 without clinical symptom or showing mild clinical manifestations (upper respiratory tract infection and mild pneumonia) shall be treated in accordance with the Guidance of the Ministry of Health (issued together with the Decision No. 322/QD-BYT dated February 06, 2020 of the Minister of Health), obstetric intervention only when there is an emergency obstetric symptom such as abdominal pain, vaginal bleeding and rupture of membranes, etc.

+ COVID-19-infected women with severe form (severe pneumonia, progressive acute respiratory distress syndrome, sepsis and septic shock, etc.), shall be treated under the Guidance of the Ministry of Health (issued together with the Decision No. 322/QD-BYT dated February 06, 2020 of the Minister of Health), consultation on each case with the infectious/resuscitation/neonatal specialties, etc.

+ To carry out diagnostic imaging techniques such as X-ray and chest CT as for non-pregnant women, paying attention to using fetal protection facilities.

+ COVID-19-infected women whether cured or not, shall be managed every 2 to 4 weeks for early detection of impaired fetal development in the uterus.

c. Obstetric interventions:

- Treatment of threatened abortion and premature labor should be based on the condition of the pregnant woman and the fetus and should be consulted with infectious/resuscitation/neonatal specialties, etc.

- When using Corticosteroid to help mature the lungs of the fetus in women infected with COVID-19 at risk of premature labor should note:

+ It s allowed to use Corticosteroid for a COVID-19 infected pregnant woman with mild clinical manifestations.

+ For a COVID-19-infected woman with severe clinical manifestations, it is required to consult with specialties (infectious/resuscitation/neonatal, etc.) before using Corticosteroid.

- To continue to monitor the fetus, not to indicate the suspension of pregnancy due to COVID-19-infected mother without clinical manifestations or clinical manifestations in mild forms.

- In case there are no emergency symptoms of obstetrics but the pregnancy is beyond the expected date of delivery, it’s required to consult a specialist to decide whether to take the baby out and choose the method of birth. If there is no abortion, advise the patient and her family to delay delivery, carry out the obstetric monitor on a daily basis.

3.2.3. Handling of delivery

- To monitor the delivery according to the National guidance on reproductive health care services issued in the Decision No. 4128/QD-BYT dated July 29, 2016 of the Minister of Health.

- There should be a combination of monitoring and treatment of obstetricians, infectious/resuscitation/internal medicine specialists, etc. In case of necessity, consult with specialized hospitals at higher levels.

-To strengthen to monitor with obstetric monitors to reduce contact between patients and medical staff.

3.2.4. Cesarean section

- Indication:

+ In accordance with specialized guidance of obstetric specialization.

+ To consider to cesarean section if the mother with severe COVID-19 infection seriously affecting respiratory function.

- The indications for cesarean section for women infected with COVID-19 are based on the maternal pathology, fetal status, gestational age and need to be consulted with specialists (obstetrics and infections/anesthesia/resuscitation health/ internal medicine/paediatrics, etc.).

In cases where an elective cesarean section is indicated, the treatment of COVID-19 should be prioritized, at the same time; such women should be monitored for cesarean section when indicated.

3.2.5. Pain relief during and after surgery

- There is no contraindication to pain relief with spinal anesthesia or epidural pain relief for people infected with COVID-19.

- If there is no contraindication, the pain relief with spinal anesthesia shall be given priority.

- Only using the general anesthesia method when it is really necessary (the mother has severe respiratory distress, the emergency situation of the pregnant woman/fetus or due to placenta praevia, etc.) because this technique increases the spread of virus. Priority is given to one-time use of air conduction system, endotracheal intubation (if available) and endotracheal intubation technique by experienced resuscitation anesthetist.

3.2.6. Take care of mother and newborns during and immediately after delivery

- For a pregnant woman suspected to be infected with COVID-19: A healthy newborn can share a room with his/her mother and their beds need to be at least 2m away from maternity beds. To discuss/consult with the mother and her family about the benefits of breastfeeding and how to prevent the risk of close contact with the mother when breastfeeding. If the mother chooses the breastfeeding, she needs to use preventive measures to limit the transmission of the virus for the baby. To wash the hands before taking care of the baby, before using a breast pump or feeding devices; to wear medical masks when feeding the baby; to clean the breast pump after using, etc.

- For a pregnant woman infected with COVID-19: To isolate the newborn and his/her mother according to the general guidance on isolation of the Ministry of Health. During the isolation period, the mother who chooses the breastfeeding needs to express milk for their baby, guide the mother on how to practice measures to prevent infection during the milking process. A mother who does not choose the breastfeeding may use milk from the breast milk bank or be instructed on how to make formula milk and feed her baby properly.

3.2.7. Take care of newborns

- A newborn from a mother infected or suspected to be infected with COVID-19 shall be tested for COVID-19 infection. The testing is regularly carried out after the child is settled and routine care is completed. To monitor until the end of the time limit as prescribed.

- To take care and treat the newborn according to the National guidance on reproductive health care services issued in the Decision No. 4128/QD-BYT dated July 29, 2016 of the Minister of Health.

- For a newborn infected with COVID-19:

+ The extent of care and treatment for a child depends on the clinical manifestations assessed and determined by neonatologists according to the National guidance on reproductive health care services and Guidance on the diagnosis and treatment of the acute pneumonia caused by new a strain of Coronavirus.

+ If the child has a fever or signs of breathing, it is necessary to monitor the living functions continuously. If the child has no symptoms, it is required to monitor his/her every 2-4 hours.

+ In case of respiratory distress syndrome (RDS) or ARDS: Surfactant and iNO may be used.

+ Only use antibiotics when there is pneumonia. Using broad-spectrum antibiotics early if there are septicemia and septic shock.

+ To consider to use ECMO if not responding to the treatment.

+ In case of septic shock and/or multiple organ dysfunction: continuous dialysis is possible.

+ There is no specific antiviral medicine for COVID-19.  Antiviral therapies, corticosteroids and intravenous immunoglobulin are not recommended and should be considered in each case.

3.2.8. Follow-up care for the mother infected with COVID-19 and newborns

All mothers and newborns shall continue to be closely examined and monitored by neonatal doctors and nurses according to the National guidance on reproductive health care services issued in the Decision No. 4128/QD-BYT dated July 29, 2016 of the Minister of Health and current regulations on prevention and treatment for the acute pneumonia caused by the COVID-19.

3.2.9. Discharge from hospital and follow up

The mother and newborn discharge requirements: After 14 days of isolation, he/she is stable, has no fever (if any) at least 3 days, the SARS-CoV 2 test is negative on 2 samples taken at least 1 day apart.

- The mother and newborn shall check the temperatures at home at least twice a day after hospital discharge, if the temperature is more than 38^oC at 2 consecutive measurements or show other abnormalities, he/she must be re-examined at the health facilities. For a child infected with COVID-19, he/she need to re-examine to check for long-term complications.

4. Organization of health facilities to meet the needs of caring for pregnant women, mothers and newborns in the COVID-19 pandemic context

4.1. The concentrated quarantine areas:To contact the provincial obstetric facilities for professional technical assistance when there are pregnant women.

4.2. Health facilities:

- Hospitals directing obstetrics and pediatrics:Hospitals assigned by the Ministry of Health to direct obstetrics and pediatrics fields shall prepare facilities (prepare negative-pressure isolation rooms under allowable conditions), equipment (especially protective equipment for health staffs) human resources ready to receive and handle cases of pregnant women, mothers and newborns suspected of being infected or infected with COVID-19; at the same time, to prepare human resources and professional technical support equipment for the downline in necessary cases.

- Hospitals for obstetrics, pediatrics, obstetrics and pediatrics, provincial general hospitals (for provinces without obstetric and pediatric hospitals):To prepare adequate facilities (prepare negative-pressure isolation rooms under allowable conditions), equipment and human resources ready to receive and handle cases of pregnant women, mothers and newborns suspected of being infected or infected with COVID-19.

FOR THE MINISTER
THE DEPUTY MINISTER

THE DEPUTY HEAD OF NATIONAL STEERING COMMITTEE FOR EPIDEMIC PREVENTION AND CONTROL

Nguyen Truong Son