Decision 3982/QD-BYT Interim Guidance for the prevention and treatment of COVID-19 in pregnant women and newborns

INTERIM GUIDANCE

FOR THE PREVENTION AND TREATMENT OF COVID-19 CAUSED BY THE SARS-COV-2 VIRUS IN PREGNANT WOMEN AND NEWBORNS

Attached to the Minister of Health’s Decision No. 3982/QD-BYT
dated August 18, 2021

I. Outline

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 diseases such as severe acute respiratory infection syndrome SARS-CoV and the 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: 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 positive single-stranded and unbroken RNA genomes, of about 30 kilobases (kb).

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, many recent studies indicate that the possibility of transmission of SARS-COV-2 virus through the placenta during pregnancy is very low. Studies from China and the US show that most samples of amniotic fluid, umbilical cord blood, placenta, vaginal fluid and breast milk of pregnant women infected with COVID-19 have negative results for SARS CoV-2 virus. At the same time, most of the test results of nasopharyngeal/pharyngeal fluid taken immediately after birth in babies born to mothers infected with COVID-19 also showed negative results for this virus. Droplet transmission is believed to be the main route of transmission when newborns come into contact with caregivers infected with SARS-CoV-2.

3. The impacts of COVID-19 on pregnant women and their unborn babies

Available data suggest that symptomatic pregnant women with COVID-19 are at increased risk of more severe illness compared with non-pregnant peers. Although the absolute risk for severe COVID-19 is low, available data indicate an increased risk of intensive care unit admission, need for mechanical ventilation and ventilatory support (ECMO), and death reported in pregnant women with symptomatic COVID-19 infection, when compared with symptomatic non-pregnant women.

For the fetus, the recent studies about COVID-19 as well as the previous studies about SARS-CoV and MERS-CoV diseases show that there is no evidence to prove a link between these diseases and congenital malformations. 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.

4. The impacts of COVID-19 on newborns

In a systematic review from scientific reports carried out in many countries with nearly 7,500 children, including 25 newborns infected with SARS-CoV-2, most children have moderate and mild symptoms, about 2% of them were admitted to intensive care unit and 0.08% of them died. According to a systematic review from 74 reports studied on 176 newborns infected with SARS-CoV-2, there are 5,1% of them needed intensive care after birth, 38% of them were admitted to intensive care unit, however, most of them were isolated according to protocol and not because of a critical illness requiring intensive care. The average length of stay in the intensive care unit was 8 days, and no death due to COVID-19 was recorded. It is reported that newborns infected with SARS-CoV-2 may show the following symptoms: fever, lethargy, cough, tachypnea, labored breathing, apnoea, vomiting, diarrhea, and poor feeding. Some symptoms are difficult to distinguish from common neonatal diseases such as alveolar resorption, endothelial disease, and neonatal sepsis.         The New York City study of 116 mothers infected with SARS-CoV-2 and their 120 newborns found that all newborns tested negative for SARS-CoV-2 within the first 24 hours of birth. 82 newborns were monitored until they are 5 - 7 days old, and 62 were placed in the same room as their mothers. All mothers were allowed to breast-feeding, 79 newborns were tested on the 5^th - 7^th day after birth and all showed negative results, 72 newborns were tested on the 14^th day and their results were also negative, no one showed clinical symptoms of COVID-19.

Essential early neonatal care including skin-to-skin contact and breastfeeding has been shown to reduce the incidence of hypothermia, hypoglycemia, respiratory distress, neonatal infections, psychological trauma, mortality and morbidity for mothers and newborns. And at the same time, there is no scientific evidence that mother-child isolation reduces the risk of SARS-CoV-2 infection for newborns. The World Health Organization recommends that remaining the first hug after birth, early essential neonatal care, and exclusive breastfeeding reduce morbidity and mortality for mothers and newborns.

II. Prevention and control of infection

1. Medical examination and treatment establishments providing obstetric and neonatal care services:

- To prepare human resources, infrastructure, means, medical equipment and supplies to perform the principles of prevention and measures to control the transmission in the medical examination and treatment establishments in accordance with available regulations of the Ministry of Health.

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

- Split-flow requirements:

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

+ To arrange separate areas to receive, screen and separate pregnant women that visit for medical examination.

+ Based on actual conditions of the locality, establishments may carry out screening by rapid test or health declaration.

+ To arrange a buffer area for pregnant women whose SARS-CoV-2 PCR test results are not available but requiring urgent intervention and a buffer area for newborns that need emergency treatment when their mothers’ PCR results are not available.

+ To arrange a separate area for providing care, treatment, monitoring for pregnant women infected or suspected of being infected with COVID-19. If possible, medical examination and treatment establishments may arrange delivery rooms and negative pressure operating rooms.

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

- To guide patients and their families to wear medical masks, disinfect by hand sanitizer and go to the quarantine areas.

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

- To restrict the movement of patients in health establishments.

- Family members accompanied with people infected or suspected of being infected with COVID-19 should be considered as exposed to COVID-19 and must also be screened until the end of the prescribed monitoring period for the early diagnosis and prevention of COVID-19.

- Health officers should advise pregnant women about COVID-19 risks and preventive measures, including:

+ Vaccinate against COVID-19 during pregnancy (pregnant ≥ 13 weeks) or in the postpartum period, even while breastfeeding according to available regulations of the Ministry of Health.

+ Taking of measures to prevent COVID-19 infection such as regularly washing hands, wearing masks, keeping a safe distance and avoiding contact with others.

- Pregnant women in blockade areas:

+ To reduce the number of direct visits, reduce the duration of each antenatal check-up, and increase the number of visits through the telemedicine system.

+ To limit the number of people coming for medical examinations sitting in the waiting room. It is recommended to make an appointment before visiting and keep a distance of more than 2 meters between pregnant women.

+ To group pregnancies of the same gestational age to schedule appointments and perform tests at the same time, in order to reduce exposure to many health staff.

+ To limit tests, only conduct those that are absolutely necessary.

+ To take some temporary diagnostic methods to replace the diagnostic methods already in the pregnancy monitoring protocol issued by the Ministry of Health, such as diagnosing gestational diabetes by combining blood glucose and HbA1c; screening for common aneuploidies by NIPS.

- Pregnant women or postpartum mothers should continue to receive tetanus vaccination according to the immunization schedule.

3. Health staff: To comply with the standard preventive and transmission-based prevention practices, take measures to prevent droplets, contact precautions and airborne transmission in accordance with available regulations of the Ministry of Health.

III. Treatment for a pregnant woman infected or suspected of being infected with COVID-19

1. Diagnosis: To comply with the Minister of Health's Decision No. 3416/QD-BYT dated July 14, 2021, on promulgating the Guidance on the diagnosis and treatment of acute pneumonia caused by the SARS-CoV-2 virus and updating documents of the Ministry of Health (if any) .

2. Treatment

2.1. Treatment principles

- Priority is given to internal medical treatment.

- To classify clinical severity and provide treatment according to the Minister of Health's Decision No. 3416/QD-BYT dated July 14, 2021, on promulgating the Guidance on the diagnosis and treatment of acute pneumonia caused by the SARS-CoV-2 virus and updating documents of the Ministry of Health (if any) .

- 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.) or when the mother show serve symptoms.

- To consider the benefits between maternal respiratory failure treatment and obstetric intervention when the pregnant women are infected with COVID-19: degree of COVID-19 infection, gestational age, gestational status, indications for emergency obstetric intervention.

2.2. Treatment for a pregnant woman infected or suspected of being infected with COVID-19

2.2.1. Antenatal care:

- During antenatal care, it is necessary to consult the risks for the mother and the fetus, in combination with the necessary measures to prevent infection and personal protection.

- To carry out antenatal care according to the National Guidance on reproductive health care services issued in the Minister of Health's Decision No. 4128/QD-BYT dated July 29, 2016. The schedule of antenatal care may change depending on the pregnancy status, maternal health and comorbid conditions of the pregnant woman; Examination through the telemedicine system can be used.

- To limit the number of medical examinations, the number of health staff in contact with patients, shorten the medical examination and test duration, use appropriate personal protective equipment when examining patients.

- To classify the clinical severity in pregnant women infected with COVID-19 according to the Decision 3416/QD-BYT and available regulatory documents (if any) of the Ministry of Health and obstetric problems such as vaginal bleeding, rupture of amniotic fluid, fetal movement decreased or no fetal movement, etc.

- To guide pregnant women to wear masks, disinfect, limit contact, and keep a safe distance.

2.2.2. Treatment for pregnant women:

- Pregnant women suspected of being infected with COVID-19: To quarantine according to available instructions of the Ministry of Health and specific local regulations.

- Pregnant women infected with COVID-19:

+ To provide care, monitoring and treatment at health establishments for COVID-19 treatment, field hospitals or at home according to current guidelines of the Ministry of Health and specific local regulations.

+ To give priority for the treatment of COVID-19, obstetric intervention only when there is an emergency obstetric symptom or when the mother's condition is severe and requires consultation with relevant specialists.

+ To perform imaging techniques such as chest X-ray and CT Scan, ultrasound, prenatal screening for non-pregnant people, use such imaging tool only when absolutely necessary with low dose radiation; pay attention to the use of means to protect the fetus.

+ COVID-19-infected pregnant women whether cured or not, shall be managed every 2 to 4 weeks for early detection of preeclampsia, intrauterine growth retardation, and threatened preterm/preterm birth.

+ Antiviral, anti-dynamic and other drugs for pregnant women infected with COVID-19 should be considered when using according to available guidelines of the Ministry of Health. Note: If taking antiviral drugs, it is necessary to monitor liver and kidney function. If a cesarean section is planned, stop anticoagulation 12-24 hours before surgery.

2.2.3. Obstetric interventions:

a) Treatment of threatened miscarriage, threatened preterm labor should be based on the condition of the pregnant woman and the fetus and should be consulted with infectious/resuscitation/neonatal specialties.

- Using Corticosteroid:

+ Pregnant women infected with COVID-19 can use corticosteroids according to available regulations of the Ministry of Health.

+ Use of corticosteroids for lung maturation purposes: Dexamethasone 6mg IV every 12 hours within 48 hours (04 doses).

b) Time and method of birth: The time of delivery should be considered on a case-by-case basis, based on the status of the mother, fetus, and gestational age, after consulting with relevant specialists, discussing with the mother and family:

- For asymptomatic cases or mildly symptomatic cases:

+ If gestational age is 39 weeks or more, consider termination of pregnancy.

+ If gestational age ranges between 37 weeks and 38 weeks 7 days without other obstetric indications: consider routine pregnancy monitoring up to 14 days from the time a pregnant woman has a positive COVID-19 test or 07 days from symptom onset or 3 days from improvement in symptoms.

- For severe cases or severe/critical prognosis within 24 hours:

+ In case of non-ventilation: If maternal condition worsens, consider termination of pregnancy at >32 weeks by induction of labor, monitoring of lower birth canal, or cesarean section.

+ In case of mechanical ventilation:

* If pregnancy > 32 weeks: consider indications for cesarean section.

* If pregnancy is ≤ 32 weeks and is likely to live: delivery should be delayed if the mother's condition is stable or improves. In case the mother's condition worsens: cesarean section;

* Consider cesarean section when gestational age is less than 30 weeks.

+ Consider terminating pregnancy in case of pregnant woman with severe COVID-19 infection that severely affects respiratory function after consultation between obstetrician, resuscitation specialist, anesthesiologist, neonatologist.

2.3. 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 disposable airways, camera intubation (if available) and intubation technique performed by an experienced anesthesiologist.

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

- It is necessary to adhere to the procedure of essential care for mothers and newborns during and immediately after birth/after cesarean section issued according to the Decision No. 4673/QD-BYT dated November 20, 2014 and the Decision No. 6734/QD -BYT dated November 15, 2016 of the Minister of Health even if the mother is infected or suspected of being infected with COVID-19. Mothers and newborns need skin-to-skin contact right after birth, stay in the same room all day and night if the mother's health condition allows, and support breastfeeding within 90 minutes after birth. For premature and low-birth-weight babies, Kangaroo care is carried out, along with the necessary measures to prevent transmission.

- Mothers and family members should be counseled that the benefits of skin-to-skin contact and breastfeeding outweigh the possible risks of COVID-19 transmission. At the same time, it is necessary to give prenatal advice on preventing the spread of the virus to the baby in close contact, including:

+ Wearing a medical mask whenever coming into contact with the baby, including when breastfeeding.

+ Changing wet medical masks immediately and throw them into waste bins with lids. It is not allowed to re-use medical masks or touch the front of the medical masks.

+ Regularly washing hands with soap and clean water for at least 20 seconds or using hand sanitizer containing at least 60% alcohol, especially before touching, taking care of babies or breastfeeding.

+ Regularly cleaning and disinfecting touched surfaces by wiping with an antiseptic solution.

2.4.1. For asymptomatic, mildly symptomatic and moderate infected pregnant women:

- It is necessary to adhere to the procedure of essential care for mothers and newborns during and immediately after birth/after cesarean section. Other routine care such as vitamin K1 injection, hepatitis B vaccine is still given within 24 hours of birth.

- Monitor vital signs and monitor fluid intake and output every 4 hours for 24 hours (after lower-line delivery) and for 48 hours (after cesarean section). Monitor SpO2 for the first 24 hours or until signs and symptoms improve in women with moderate disease (whichever is longer).

- Based on the conditions of the health establishment, the pandemic situation of the locality, the ability to meet the human resources, consider separating or arranging the baby and mother to be in the same room (if possible, arrange mother and baby beds are 2 meters apart). Health staff shall support the mother to breastfeed the baby when being in hospital and after hospital discharge.

- For babies born prematurely and with low birth weight < 2,000g, support mothers or relatives in taking care of babies according to Kangaroo method.

2.4.2. For infected pregnant women with severe or critical pneumonia

- In case the mother is in poor health and cannot take care of the newborn, he/she should be taken care of by a healthy relative. Ensure principles to prevent infection:

+ Arrange separate rooms for newborns and relatives or share rooms with others at the same risk of exposure to COVID-19.

+ Health staff shall be responsible for supporting and monitoring newborns, or in charge of taking care of them, if they have no relatives.

- Mothers should be supported to provide breast milk in the safest, most available and appropriate way, including:

+ Health staff shall help mothers express milk to feed their babies

+ Use pasteurized milk from a breast milk bank if breast milk cannot be expressed

+ If it is not possible to express breast milk and there is no breast milk bank, the child-rearing shall be carried out according to the instructions of the health staff and instructions for the family to properly feed the baby.

- As soon as the mother is stable, the baby should be put in the same room as the mother and breastfed early. Mothers and relatives need to ensure infection prevention principles when caring for newborns.

- Health officers should be trained in early essential neonatal care, infection prevention and breastfeeding counseling.

- Consider prophylactic anticoagulation for postpartum women with severe/critical COVID-19 infection, if there are no contraindications, and stop using anticoagulation when the mother is discharged from hospital.

- It is necessary to differentiate postpartum fever in patients with COVID-19 from infectious conditions such as postpartum endometritis, surgical site infection, inflammation or breast abscess, etc.

2.5. Take care of newborns

- A newborn from a mother infected or suspected of being infected with COVID-19 shall be tested for COVID-19 infection. The testing is regularly carried out after the baby is in stable condition and routine care is completed.

+ For a newborn from an infected mother: He/she shall be tested for the first time when he/she is 2 to 24 hours old, his/her face should be washed or wiped before sampling. Sampling site: Throat or nose. A newborn shall be tested for the second time when he/she is 48 hours old, the third and fourth tests shall be carried out when he/she is 7 and 14 days old, respectively.

+ For a newborn in close contact with an infected person or his/her mother who is infected after birth: procedures for diagnosis and monitoring are the same as those of adults.

+ Where conditions are limited, priority should be given to testing newborns with symptoms of COVID-19 as well as newborns exposed to SARS-CoV-2 requiring care at intensive care unit or expected for prolonged hospitalization.

+ A newborn with a confirmed COVID-19 test may be arranged to sleep with his/her mother if the mother and newborn do not require special care, on the basis of providing sufficient information about the benefits and risks to the mother and family.

- Based on the practical conditions of the health establishment/locality, it is possible to allow family members to support child care. The mother or caregiver must use a mask and wash hands when directly caring for the newborn.

- For a newborn infected with COVID-19:

+ The level of care and treatment of the newborn shall depend on the clinical manifestations and be assessed and decided by the neonatologist.

+ If the baby show signs of respiratory distress, it is necessary to monitor the living functions continuously through the monitor. If the baby shows no symptoms or mild symptoms, record vital functions every 4 - 6 hours.

Antibiotics should only be used when an infection cannot be ruled out. Broad-spectrum antibiotics shall be used if there are septicemia and septic shock.

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

+ Consider using ECMO if not responding to the treatment.

+ Currently, there is not any specific effective antiviral medicine for COVID-19. Antiviral therapies, corticosteroids and intravenous immunoglobulin should be considered in each case.

- For a newborn requiring long-term hospital care, the caregiver should continue to use appropriate personal protective equipment until the baby is discharged from the hospital or when the newborn has two consecutive negative tests that are collected ≥ 24 hours apart. The RT-PCR test is optimal for sick and premature newborns because the duration of infectious virus shedding is unknown.

- Infected newborns who are receiving respiratory support should be kept in an incubator or in a separate room. Note: The distance of 2 meters between sick cots should be kept to limit cross-infection.

2.6. 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 Minister of Health's Decision No. 4128/QD-BYT dated July 29, 2016 and available regulations on prevention and treatment for acute pneumonia caused by the COVID-19.

2.7. Discharge from hospital and monitoring:

- Comply with criteria for discharge from hospital provided in the Decision No. 3416/QD-BYT and available regulations of the Ministry of Health. Based on the pandemic situation and practical conditions of the locality to consider transferring patients to lower-level hospitals for further monitoring and treatment (field hospital, quarantine areas provided treatment of district-level hospitals, etc.) or transfer them for home quarantine (if eligible).

- Post-discharge follow-up: Follow-up after birth, after routine surgery shall not be conducted. The mothers and newborns shall continue to be quarantined at home under the supervision of the local health establishments and the local Centers for Disease Control for another 14 days. It is required to monitor body temperature twice a day, if the body temperature is higher than 38^o5C at 2 consecutive measurements or there are any abnormal clinical signs, it is necessary to immediately go to a health establishment for examination and timely treatment.

- For a baby infected with COVID-19, he/she need to be re-examined to check for long-term complications.

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

1. Concentrated quarantine areas: To contact the provincial obstetric facilities for professional technical assistance when there are pregnant women.

2. Health establishments:

- Hospitals in charge of directing obstetrics and pediatrics sectors: Hospitals assigned by the Ministry of Health to direct obstetrics and pediatrics sectors shall prepare facilities (prepare negative-pressure quarantine rooms under allowable conditions), equipment (especially protective equipment for health staff) human resources ready to receive and provide treatment for 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 lower levels in necessary cases.

- Maternity, pediatric, obstetric and pediatric hospitals, provincial general hospitals (for provinces without specialized obstetric and pediatric hospitals): It is necessary to prepare adequate facilities (prepare negative-pressure quarantine rooms under allowable conditions), equipment and human resources ready to receive and provide treatment for pregnant women, mothers and newborns suspected of being infected or infected with COVID-19; support quarantine establishments and lower-level health establishments in caring pregnant women, mothers and newborns.