MINISTRY OF HEALTH | SOCIALISTREPUBLIC OF VIETNAM |
No. 3982/QD-BYT | Hanoi, August 18, 2021 |
MINISTER OF HEALTH
Pursuant to the Government’s Decree No.75/2017/ND-CP dated June 20, 2017 on functions, duties, powers and organizational structure of the Ministry of Health;
At the request of Director General of the Maternal and Child Health Department, Ministry of Health,
HEREBY DECIDES:
Article 1.Promulgated together with this Decision are the interim guidelines for prevention and treatment of COVID-19 in pregnant women and newborns.
Article 2. This Decision takes effect from the date on which it is signed. Decision No. 1271/QD-BYT dated 21/3/2020 by the Minister of Health introducing interim guidelines for prevention and treatment of COVID-19 in pregnant women and newborns is annulled.
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P.P THE MINISTER
THE DEPUTY MINISTER
Nguyen Truong Son
Head of Treatment Subcommittee
National Steering Committee for COVID-19 Prevention and Control
PREVENTION AND TREATMENT OF COVID-19 IN PREGNANT WOMEN AND NEWBORNS
Enclosed with Decision No. 3982/QD-BYT dated August 18, 2021 by Minister of Health
1. The virus
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Coronaviruses are spherical with diameters of approximately 125 nm and spike-shaped proteins projecting from the surface. They contain four main structural proteins, which are the spike (S), membrane (M), envelope (E), and nucleocapsid (N) proteins. Inside the envelop is the single-stranded and helically symmetrical nucleocapsid. Coronaviruses have positive-sense, single-stranded and non-segmented RNAs of about 30 kb.
2. Transmission
SARS-CoV-2 is a new strain of coronavirus that causes COVID-19 and was first detected in Wuhan City, China. This strain of virus is capable of animal to human transmission and direct human to human transmission via the droplet, respiratory and close contact routes.
For pregnant women, to date, many studies indicate that there is a very low chance of SARS CoV-2 transmission via the placenta during pregnancy. Chinese and American studies show that the majority of amniotic fluid, core blood, placenta, vaginal discharge and milk samples from pregnant COVID-19 patients tests negative for SARS CoV-2; concurrently, most nasal/throat swabs from babies born to mothers with COVID-19 collected immediately after birth test negative for the virus. Droplet transmission is considered to be the primary route of transmission from caregivers with COVID-19 to babies.
3. Effects of COVID-19 on pregnant women and fetuses
Available data suggests that symptomatic pregnant COVID-19 patients face higher risk of severe illness than non-pregnant patients. Despite low risk of severe illness, available data indicates that symptomatic pregnant COVID-19 patients have higher risk of ICU admission, mechanical ventilation and ECMO and fatality than symptomatic non-pregnant patients.
For fetuses, recent studies on COVID-19 as well as past studies on SARS-CoV and MERS-CoV show that there is no proof of a connection between these diseases and congenital malformations. However, some evidences suggest that viral pneumonia in pregnant women is related to an increased risk of premature birth, slow fetal growth, neonatal death, etc..
4. Effects of COVID-19 on newborns
A study consolidated from scientific reports of many countries involving close to 7500 pediatric SARS-CoV-2 infections, including 25 neonatal infections, reveals that most children experienced moderate and mild symptoms, with 2% of the children needing ICU admission and a case fatality proportion of 0,08%. A study consolidated from 74 reports on 176 neonatal SARS-CoV-2 infections found that 5,1% and 38% of the newborns required neonatal resuscitation and ICU admission respectively; however, most of these babies were quarantined due to procedural reason, not critical illness requiring intensive care. Average length of ICU stay was 8 days. No COVID-19 death was reported. Neonatal COVID-19 patients were reported to have fever, lethargy, cough, rapid breathing, labored breathing, stopped breathing, vomit, diarrhea and feeding problems. Some symptoms were hard to differentiate from those of common neonatal conditions such as slow lung fluid absorption, hyaline membrane disease and neonatal infection. A study in New York City on 116 mothers with COVID-19 and 120 newborns of these mothers showed that all babies tested negative for SARS-CoV-2 within 24 hours after birth. 82 babies were monitored until they reached 5-7 days of age and 68 babies stayed in the same rooms as their mothers. All mothers were breastfeeding. 79 babies tested negative for the virus on the 5th to 7th day after birth, 72 babies tested negative for the virus on the 14th day after birth and none of the babies had clinical symptoms of COVID-19.
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II. Prophylaxis and infection control
1. For healthcare establishments providing obstetric and neonatal care services:
- Prepare personnel, facilities, medical materials and equipment to follow prophylaxis rules and adopt infection control measures in healthcare establishments according to existing regulations of the Ministry of Health.
- Ensure sufficient prophylaxis equipment, especially personal protective equipment, hand sanitizer and medical masks.
- Classification requirements:
+ Organize screening, early detection and management of confirmed or suspected COVID-19 cases at reception point.
+ Prepare a separate area to receive, screen and classify pregnant women.
+ Based on actual local situation, carry out screening via rapid testing or risk screening via health declaration.
+ Prepare an anteroom for pregnant women whose SARS-CoV-2 PCR test results are not yet available requiring emergency aid and an anteroom for newborns needing emergency aid when their mothers' PCR test results are not yet available.
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2. For pregnant women and mothers visiting for checkups (hereinafter referred to as “patients”):
- Instruct patients and their family to wear face masks, wash their hands using hand sanitizer and visit the quarantine area.
- Request patients to keep a distance of at least 2 meters.
- Patients should avoid walking around the healthcare facility.
- Any family member accompanying a confirmed or suspected COVID-19 case shall be considered to have been exposed to COVID-19 and must be monitored throughout the required period to facilitate early diagnosis and prevention of COVID-19.
- Health officials should advise pregnant women on risks posed by COVID-19 and COVID-19 preventive measures, specifically:
+ Get vaccinated against COVID-19 during pregnancy (fetus ≥ 13 weeks) or postpartum period, including when they are breastfeeding according to existing regulations of the Ministry of Health.
+ Take COVID-19 preventive measures such as washing hands regularly, wearing face masks, keeping safe distance and avoiding contact.
- For pregnant women living in quarantined areas:
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+ Limit number of people in the waiting room, set up appointments in advance and request pregnant women to keep a distance of more than 2 meters.
+ Group pregnancies with similar gestational age to have the pregnant women visit for examination and take tests at the same time, limiting their contact with multiple healthcare workers.
+ Limit testing and follow indications strictly necessary.
+ Use some interim diagnostic methods instead of diagnostic methods included in pregnancy monitoring regimens promulgated by the Ministry of Health such as diagnosing gestational diabetes by combining blood glucose and HbA1c; and screening common aneuploidies by NIPS.
- Women shall receive tetanus vaccine during pregnancy and postpartum period according to vaccination schedule.
3. For healthcare workers: apply standard precautions, transmission-based precautions and precautions against droplet, contact and airborne transmission according to existing regulations of the Ministry of Health.
III. Handling of pregnant women suspected or confirmed to have COVID-19
1. Diagnosis: implement Decision No. 3416/QD-BYT dated 14/07/2021 by the Minister of Health on COVID-19 diagnosis and treatment guidelines and updates thereof (if any) of the Ministry of Health.
2. Handling
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- Prioritize internal medicine treatments.
- Determine severity and provide treatment according to Decision No. 3416/QD-BYT dated 14/07/2021 by the Minister of Health on COVID-19 diagnosis and treatment guidelines and updates thereof (if any) of the Ministry of Health.
- Avoid obstetric interventions when the mother is suspected or confirmed to have COVID-19, unless emergency interventions (anterior placenta/placenta accreta with heavy bleeding, placental abruption, fetal distress, etc.) or subacute care (water breaking, labor, etc.) are/is indicated or there are signs that the mother’s condition is worsening.
- Consider the benefits of respiratory failure treatment for the mother against that of obstetric intervention when the mother is having COVID-19 based on COVID-19 severity, gestational age, fetal condition and indications for emergency obstetric interventions.
2.2. Handling of pregnant women suspected or confirmed to have COVID-19
2.2.1. Antenatal care:
- During antenatal care, advise on risks faced by the mother and the fetus together with necessary preventive measures.
- Provide antenatal care according to the national guidelines for reproductive healthcare services promulgated together with Decision No. 4128/QD-BYT dated 29/7/2016 by the Minister of Health. The antenatal care schedule may be changed depending on fetal condition, maternal health and maternal comorbidity; antenatal care may be provided remotely.
- Reduce number of physical examinations, reduce number of healthcare workers having contact with the mother, reduce duration of each physical examination and use suitable personal protective equipment when performing physical examination.
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- Instruct pregnant women on using face masks, disinfection, avoiding contact and safe distancing.
2.2.2. Handling of pregnant women:
- For pregnant women suspected to have COVID-19: place them under quarantine according to existing regulations of the Ministry of Health and local specific provisions.
- For pregnant women confirmed to have COVID-19:
+ Care for, monitor and treat pregnant patients in COVID-19 treatment facilities or temporary hospitals or at home according to existing regulations of the Ministry of Health and local specific provisions.
+ Prioritize COVID-19 treatment; only make obstetric intervention when the mother shows signs that she needs emergency obstetric aid or her condition worsens, requiring consultation with relevant departments.
+ Perform imaging techniques such as X-ray, chest CT scanning, ultrasound and prenatal screening applicable to non-pregnant women, use these imaging techniques only where strictly necessary and with low radiation dose, and ensure that the fetus is protected during use.
+ Pregnant women with COVID-19 (including those having recovered) should undergo fetal management every 2-4 weeks to detect pre-eclampsia, slow fetal growth and threatened premature birth/premature birth early on.
+ Consider the use of antiviral drugs, anticoagulant drugs and other types of drugs for pregnant COVID-19 patients according to existing regulations of the Ministry of Health. Note: monitor liver and kidney functions if using antiviral drugs; stop using anticoagulants 12-24 hours before C-section.
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a) Treat threatened miscarriage and threatened premature birth based on maternal and fetal conditions and consultation with infection/ICU/neonatal departments.
- Use of Corticosteroids:
+ Pregnant COVID-19 patients may use Corticosteroids according to existing regulations of the Ministry of Health.
+ Use Corticosteroids for lung maturation: Dexamethasone 6mg, intravenous injection, every 12 hours for 48 hours (04 doses).
b) For birth time and method: consider birth time on a case-by-case basis based on maternal condition, fetal condition and gestational age and after consultation with relevant departments and discussion with the mother and the family:
- For COVID-19 patients with no or mild symptoms:
+ If the fetus is at 39 weeks or older, consider ending the pregnancy.
+ If the fetus is at 37 weeks - 38 weeks 7 days and there is no other obstetric indications, consider regular fetal monitoring until the 14th day after the mother tests positive for COVID-19 or 7th day after symptom onset or 3rd day after symptom improvement.
- For COVID-19 cases that are severe or predicted to become severe/critical in the next 24 hours:
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+ If the mother is ventilated:
* If the fetus is older than 32 weeks, consider C-section.
* If the fetus is at 32 weeks or younger and capable of surviving, delay birth if maternal condition is stable or has improved; otherwise, perform C-section;
* Consider C-section if the fetal is younger than 30 weeks.
+ Consider ending the pregnancy if the mother is severely ill and her respiratory function is heavily impaired after consultation with obstetric, ICU, anesthesia-resuscitation and neonatal departments.
2.3. Pain control during and after surgery
- There is no contraindication for pain control via spinal or epidural anesthesia for COVID-19 patients.
- Prioritize spinal anesthesia if there is no contraindication.
- Use general anesthesia only where strictly necessary (when the mother has severe respiratory failure, the mother/fetus requires emergency aid, there is anterior placenta, etc.) as this technique facilitates the spread of the virus. Prioritize use of single-use breathing systems, endotracheal intubation via camera (if available) and endotracheal intubation by experienced anesthesia-resuscitation doctors.
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- Follow procedures for essential care of mothers and newborns during and immediately after birth/C-section promulgated together with Decision No. 4673/QD-BYT dated 20/11/2014 and Decision No. 6734/QD-BYT dated 15/11/2016 by the Minister of Health even when the mother is suspected or confirmed to have COVID-19. The mother and her baby should have skin-to-skin contact immediately after birth, stay in the same room during the day and at night if the mother’s condition allows it and be supported with breastfeeding within 90 minutes after birth. For premature and underweight babies, provide Kangaroo care and take necessary precautions against infection.
- Advise the mother and her family that the benefits of skin-to-skin contact and breastfeeding outweigh the risk of COVID-19 transmission. Concurrently, before birth, provide advice on prevention of virus transmission to babies during close contact, specifically:
+ Always wear a medical mask when having contact with the baby, including breastfeeding.
+ Replace medical mask immediately if the mask is damp and discard the mask in a garbage bin with lid. Do not reuse medical masks or touch the front of the mask.
+ Regularly wash hands with soap and water for at least 20 seconds or hand sanitizer containing at least 60% alcohol, especially before touching, caring for or feeding the baby.
+ Regularly clean and disinfect surfaces touched by the mother by wiping them with a disinfectant solution.
2.4.1. For mothers with asymptomatic, mild and moderate COVID-19:
- Follow procedures for essential care of mothers and newborns during and immediately after birth/C-section. Carry out other regular care activities such as Vitamin K1 injection and hepatitis B vaccination within 24 hours after birth.
- Monitor vital signs and fluid intake and output every 4 hours for 24 hours (after vaginal birth) and for 48 hours (after C-section). Monitor SpO2 for the first 24 hours or until signs and symptoms improve if the mother has moderate COVID-19 (whichever period is longer).
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- For babies who are premature and weighing <2000 grams, assist the mother or a family member with providing Kangaroo care for the baby.
2.4.2. For mothers having COVID-19 with severe pneumonia or in critical condition
- If the mother is in poor health and unable to take care of her baby, the baby should be cared for by a healthy family member. Take the following precautions:
+ Let the baby and the family member stay in a separate room or together with persons facing similar risk of exposure to COVID-19.
+ Healthcare workers shall provide support and monitor the baby or care for the baby directly if no family member is available.
- Assist the mother with breastfeeding her baby in the safest and most convenient manner. To be specific:
+ Healthcare workers shall assist the mother with collecting breast milk for the baby.
+ Use pasteurized milk from the breast milk bank if unable to collect the mother’s milk.
+ If the mother’s milk cannot be collected and there is no breast milk bank, care for the baby according to indications of health officials and instruct the family on how to feed the baby.
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- Health officials shall receive training in essential early newborn care, infection control and breastfeeding advice and assistance.
- Consider administering anticoagulant drugs with prophylactic dosage to mothers with severe/critical COVID-19 after birth if there is no contraindication and stop such administration when the mother is discharged.
- Differentiate postpartum fever in COVID-19 patients from infections such as postpartum endometritis, post-cesarean wound infection, breast infection or abscess, etc.
2.5 Neonatal care:
- Babies born to mothers suspected or confirmed to have COVID-19 must be tested for COVID-19, usually after the baby’s condition has stabilized and regular care activities are completed, as follows:
+ Babies born to mothers with COVID-19 shall have the first test within 2 to 24 hours after birth; remember to clean or wipe their faces before sample collection. Collect a sample from the throat or nose. The second, third and fourth tests shall take place 48 hours, 7 days and 14 days after birth respectively.
+ Babies who have close contact with a COVID-19 patient or whose mothers have COVID-19 after birth shall be tested and monitored as applicable to adults.
+ For areas with limited resources, prioritize testing of newborns having COVID-19 symptoms, newborns exposed to SARS-CoV-2 and requiring intensive care or newborns expected to have prolonged hospital stay.
+ Newborns with positive COVID-19 test results may stay with their mothers if both mother and baby do not require special care and the mother and the family are informed about the benefits and risks.
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- For newborns with COVID-19, take note of the following matters:
+ Levels of care and treatment for the baby shall depend on clinical manifestations as evaluated and decided by neonatologists.
+ If the baby shows signs of respiratory failure, monitor vital functions continuously via monitors. If the baby has no symptom or mild symptoms, monitor vital functions every 4-6 hours.
+ Only use antibiotics when there is comorbid infection. Use broad-spectrum antibiotics if there are sepsis and septic shock.
+ Cases with septic shock and/or multi-organ failure may receive continuous renal replacement therapy.
+ Consider using ECMO if the patient does not respond to treatment.
+ There is no effective antiviral drug for COVID-19. Intravenous immunoglobulin, corticosteroid and antiviral therapies must be considered on a case-by-case basis.
- For newborns requiring long-term hospitalization, the caregiver should use suitable personal protective equipment until the baby is discharged or has two consecutive negative test results produced at least 24 hours apart. RT-PCR testing is optimal for ill and premature babies as the exposure time is unknown.
- Newborns with COVID-19 receiving respiratory support should stay in an incubator or a private room. The cots of ill babies shall be placed 2 meters apart to prevent cross-contamination.
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All mothers and babies shall have checkups and be closely monitored by neonatal doctors and nurses according to the national guidelines for reproductive healthcare services promulgated together with Decision No. 4128/QD-BYT dated 29/7/2016 by the Minister of Health and existing regulations on COVID-19 prevention and handling.
2.7. Discharge and monitoring:
- Apply discharge standards in Decision No. 3416/QD-BYT and existing regulations of the Ministry of Health. Based on the COVID-19 situation and actual local condition, consider transferring patients to hospitals at lower levels of care for further monitoring and treatment (temporary hospitals, quarantine and treatment facilities of district-level hospitals, etc.) or back home for home quarantine (if possible).
- Post-discharge monitoring: there shall be no follow-up examination after normal C-section or birth; continue to undergo home quarantine under the supervision of grassroots healthcare facility and local CDC for 14 days and take body temperature twice a day; if temperature is higher than 38o5C at both times or there is any unusual clinical sign, visit a healthcare facility for timely examination and handling.
- Babies recently infected with COVID-19 need checkups to monitor long-term effects.
1. For centralized quarantine facilities: contact provincial obstetric facilities to provide pregnant women with professional support.
2. For healthcare facilities:
- Hospitals providing guidance onobstetric and pediatric care: hospitals assigned to provide guidance on obstetric and pediatric care by the Ministry of Health shall prepare facilities (prepare negative pressure rooms within capacity), equipment (especially protective equipment for healthcare workers) and personnel to receive and handle pregnant women, mothers and newborns confirmed or suspected to have COVID-19; concurrently, prepare personnel and equipment to provide professional support for lower levels of care where necessary.
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