III Methodology
Basic principles
The method used to prepare this guideline was determined by the class to which this
guideline was assigned. The AWMF Guidance Manual (version 1.0) has set out the respective
rules and
requirements for different classes of guidelines. Guidelines are differentiated into
lowest (S1), intermediate (S2), and highest (S3) class. The lowest class is defined
as consisting of a
set of recommendations for action compiled by a non-representative group of experts.
In 2004, the S2 class was divided into two subclasses: a systematic evidence-based
subclass (S2e) and a
structural consensus-based subclass (S2k). The highest S3 class combines both approaches.
This guideline was classified as: S2k
Grading of recommendations
The grading of evidence based on the systematic search, selection, evaluation, and
synthesis of an evidence base which is then used to grade the recommendations is not
envisaged for S2k
guidelines. Individual statements and recommendations are only differentiated by syntax,
not by symbols ([Table 3 ]).
Table 3 Grading of recommendations (based on Lomotan et al., Qual Saf Health Care 2010).
Description of binding character
Expression
Strong recommendation with highly binding character
must/must not
Regular recommendation with moderately binding character
should/should not
Open recommendation with limited binding character
may/may not
Statements
Expositions or explanations of specific facts, circumstances, or problems without
any direct recommendations for action included in this guideline are referred to as
“statements.” It is
not possible to provide any information about the level of evidence for these statements.
Achieving consensus and level of consensus
At structured NIH-type consensus-based conferences (S2k/S3 level), authorized participants
attending the session vote on draft statements and recommendations. The process is
as follows. A
recommendation is presented, its contents are discussed, proposed changes are put
forward, and all proposed changes are voted on. If a consensus (> 75% of votes) is
not achieved, there is
another round of discussions, followed by a repeat vote. Finally, the extent of consensus
is determined, based on the number of participants ([Table 4 ]).
Table 4 Level of consensus based on extent of agreement.
Symbol
Level of consensus
Extent of agreement in percent
+++
Strong consensus
> 95% of participants agree
++
Consensus
> 75 – 95% of participants agree
+
Majority agreement
> 50 – 75% of participants agree
–
No consensus
< 51% of participants agree
Expert consensus
The term “expert consensus” is used to characterize consensus decisions specifically
relating to recommendations/statements issued without a prior systematic search of
the literature (S2k)
or where evidence is lacking (S2e/S3). The term “expert consensus” (EC) used here
is synonymous with terms used in other guidelines such as “good clinical practice”
(GCP) or “clinical
consensus point” (CCP). The strength of the recommendation is graded as previously
described in the chapter Grading of recommendations but without the use of symbols; it is only
expressed semantically (“must”/“must not” or “should”/“should not” or “may”/“may not”).
IV Guideline
1 General comments on the SARS-CoV-2 pandemic
With new virus variants emerging and the infections coming in waves, the dynamics
of the SARS-CoV-2 pandemic are not foreseeable. It can be assumed that COVID-19, the
disease triggered by
SARS-CoV-2, will remain challenging even after the pandemic, whether the disease continues
in its current form or similar. In addition to the recommendations for pregnant women,
parturient
women, women who have recently given birth, and neonates provided in this guideline,
it is important to be aware of additional sources reporting on the treatment of affected
persons and the
management of infection which include the latest findings.
The following sources should be of particular interest (please note that most of these sources are in German):
Recommendations of the RKI on hygiene measures in the context of treating and caring
for patients with SARS-CoV-2 infection: https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Hygiene.html
Extended hygiene measures used in the German healthcare system during the COVID-19
pandemic: https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/erweiterte_Hygiene.html
The German law on preventing and combating infectious diseases in humans (Infection
Protection Law, Infektionsschutzgesetz – IfSG): https://www.gesetze-im-internet.de/ifsg/index.html#BJNR104510000BJNE002305116
Sec. 28a Special protection measures to prevent the spread of the coronavirus 2019
disease (COVID-19)
Sec. 28b Uniform protection measures used across all of Germany to prevent the spread
of the coronavirus 2019 disease (COVID-19) in special occurrences of infection, the
power to
issue statutory instruments
Sec. 28c Power to issue statutory special regulations for vaccinated, tested and comparable
persons
The German-language S2e-guideline with the AWMF registry no. 053-054: “SARS-CoV-2/Covid-19
Information & Practical Help for General Practitioners in Private Practice” [1 ].
The German-language S3-guideline with the AWMF registry no. 113/001: “Recommendations
for the Inpatient Treatment of Patients with COVID-19” [2 ].
The authors have attempted to keep this guideline as short and readable as possible.
The evidence pertaining to some aspects or parts of the guideline is therefore discussed
and summarized
in more detail in the “Recommendations on SARS-CoV-2/COVID-19 in Pregnancy, Birth
and Puerperium – Update November 2021” prepared by the DGGG and DGPM [3 ].
This information is also available on the website of the DGGG and the DGPM together
with the latest, regularly published recommendations and statements which take account
of the current
state of the pandemic and include new findings.
Responsibility for ensuring that the load on the healthcare system is balanced
During the pandemic, the specific healthcare structures of the federal states had
to be coordinated. Many of the federal states in Germany envisaged a decentralized
treatment structure to
deal with persons who were SARS-CoV-2-positive or who developed COVID-19 to make optimum
use of the resources of the healthcare system. When considering the care of obstetric
patients, the
guideline authors are of the opinion that obstetric criteria used when deciding whether
patients need to be treated in hospital and the care level available at the center
treating them are
already sufficient to deal with the issue [4 ], [5 ]. There are no indications that a pregnant woman with only (asymptomatic or
mild) SARS-CoV-2 infection needs to be transferred to a special center of maximum
care with a neonatal intensive care unit. It is the responsibility of every outpatient
and inpatient care
facility to care for patients who have tested positive for SARS-CoV-2 and adapt their
care structures accordingly.
2 Prevention of infection
Pregnant women have a higher risk of COVID-19 taking a more severe course compared
to non-pregnant women of the same age. When attempting to prevent infection, the primary
challenge is how
to deal with asymptomatic infected women who attend hospital appointments. This means
that obstetric and neonatology departments constitute a particularly sensitive area
in healthcare
facilities, and measures must be agreed upon, based on interdisciplinary and interprofessional
cooperation, which will protect fellow patients and the staff treating them. In addition
to
ensuring that rooms are adequately aired and ventilated and that general hygiene measures
such as disinfecting hands are in place, the wearing of a FFP by the staff and patients
and
screening for infectious agents are effective measures which can protect all involved
contact persons [1 ], [2 ], [6 ], [7 ]. The birth-specific aspects in clinical settings, which are important in a pandemic,
are described below.
2.1 Wearing a filtering facepiece (FFP)
Consensus-based recommendation 2.E1
Expert consensus
Level of consensus +++
An FFP must be worn when visiting a hospital.
Consensus-based recommendation 2.E2
Expert consensus
Level of consensus +++
If the test result was negative and the woman giving birth has no typical clinical
symptoms of COVID-19, she must be allowed not to wear an FFP.
Consensus-based recommendation 2.E3
Expert consensus
Level of consensus +++
If the test results have not yet come back or the woman has tested positive or has
typical COVID-19 symptoms, the parturient woman must wear an FFP.
Consensus-based recommendation 2.E4
Expert consensus
Level of consensus +++
The medical staff present at the birth and other persons present should wear an FFP.
Effect of wearing an FFP on transmission of the virus
It was found that wearing an FFP significantly reduced the risk of transmission [8 ]. Medical and hospital staff wearing an FFP (OR 0.11; 95% CI:
0.03 – 0.39; p < 0,001), wearing gloves (OR 0.39; 95% CI: 0.29 – 0.53; p < 0.001),
and wearing medical scrubs (OR 0.59; 95% CI: 0.48 – 0.73; p < 0.001) reduced the transmission
rate [9 ]. According to a study carried out in the USA, if a case-patient and a contact both
wore an FFP, the transmission rate was reduced even further
(from 25.6% to 12.5%) [10 ]. A German scenario study modelled the effect of different protection measures to
prevent the transmission of infection to
medical staff when caring for parturient women. According to the study, if a highly
infectious patient wore an FFP2 mask, the risk of infection for the midwife decreased
from 30% to 7%.
Additional active ventilation of the room further reduced the risk to 0.7%. If the
woman giving birth wore an FFP, the risk decreased even more to 0.3% [11 ]. The guideline authors are of the opinion that the birthing process, especially
the expulsion phase, is an aerosol-forming situation which results in relevant exposure
and
therefore involves a relevant risk of transmission to the medical staff providing
the care.
2.2 Testing and screening for SARS-CoV-2
Consensus-based recommendation 2.E5
Expert consensus
Level of consensus +++
During the pandemic, each female patient must be asked about symptoms and her history of SARS-CoV-2 infection risks prior to receiving
treatment in a healthcare facility
(whether as an outpatient or an inpatient).
Consensus-based recommendation 2.E6
Expert consensus
Level of consensus +++
Diagnostic testing must be carried out if there is a clinical suspicion consistent with SARS-CoV-2 infection
(COVID-19) based on the patientʼs medical history, symptoms,
or findings, irrespective of the patientʼs vaccination status.
Consensus-based recommendation 2.E7
Expert consensus
Level of consensus +++
Screening for SARS-CoV-2 must be carried out prior to every admission to hospital or admission for the birth, in
accordance with the recommendations of the RKI and the
national testing strategy as well as any directives issued by federal states.
Consensus-based recommendation 2.E8
Expert consensus
Level of consensus +++
The results of a SARS-CoV-2 test should be available prior to admission for any elective procedure, e.g., for a planned caesarean
section, cerclage, or induction of
labor.
National testing strategy
The RKI regularly publishes updates of the national testing strategy, which must be
complied with in healthcare facilities during the pandemic: “Testing in inpatient
or outpatient
facilities is basically indicated if there is a clinical suspicion consistent with
a SARS-CoV-2 infection (COVID-19) based on the patientʼs history, symptoms or findings.”
It is also
recommended that “patients should in principle be tested prior to (re-) admission
as well as prior to any outpatient procedures […] with a nose-and-throat swab and
a SARS-CoV-2 PCR test.
[…] The threshold for indicating a diagnostic workup should be low and depends on
the epidemic situation.” (As at 1.11.2021) [12 ]
Special aspects affecting facilities caring for pregnant women
From the perspective of preventing infection, facilities which care for pregnant women,
parturient women, and their newborn infants are a particularly sensitive issue. As
the women are
young and healthy and sometimes asymptomatically infected, identifying them is important
as this allows measures to be taken to protect the staff, fellow patients, and their
families. A
nosocomial infection acquired from a fellow patient in hospital which then requires
a form of quarantine will complicate the infected patientʼs access to follow-up medical
care from
midwives and medical practices. Although the disease may often be asymptomatic, pregnant
women, particularly in the second half of their pregnancy, have a higher risk of suffering
a more
severe course of COVID-19 [13 ] and therefore require special protection.
Prevalence of SARS-CoV-2 infection in pregnancy
Pregnant women do not have a higher risk of being infected with SARS-CoV-2. Screening
has confirmed that the prevalence of infection is similar to that of the general population
with
regards to its regional and temporal course [14 ], [15 ], [16 ], [17 ], [18 ], [19 ], [20 ], [21 ], [22 ], [23 ], [24 ]. However, there are indications that some groups of female patients have a
higher risk of infection based on their ethnicity [25 ], [26 ], [27 ], [28 ], [29 ], [30 ] or socio-economic status [31 ], [32 ]. A population-based British cohort study (3527 SARS-CoV-2 infections in 342 080
pregnant women) showed that SARS-CoV-2 infection occurred more often in
women who were younger and were primipara, belonged to a non-white ethnic group, lived
in disadvantaged areas, or had comorbidities [33 ]. Moreover, the
prevalence of infection appeared to increase as the gestational age increased [34 ], [35 ]. In hospital registries, the
number of infected pregnant women in their 3rd trimester pregnancy dominated, constituting
83% (UKOSS) or 64.3% (CRONOS) of all registered infected pregnant women [36 ], [37 ].
Symptomatic versus asymptomatic female patients
According to studies from New York, London, and Connecticut, the overwhelming (up
to 89%) percentage of women who tested positive on admission to hospital to give birth
were
asymptomatic [38 ] – [40 ]. In Great Britain, out of 1148 pregnant women with SARS-CoV-2 infection cared for
between March
and August 2020 the percentage of asymptomatic patients was 37% [36 ]. This corresponds to the data obtained from German hospitals included in the CRONOS
registry up until 1st October 2020, which recorded 37% of women as asymptomatic [37 ].
CRONOS (as at 24th August 2021): Of the 785 women with known infection around the
time of their due date from week 37 + 0 of gestation, the rate of asymptomatic women
was 55.6%
(437/785; no information about symptoms for 23 women). The circumstances of the positive
SARS-CoV-2 tests were recorded for 657 women. Of the 354 asymptomatic women, 306 (86.4%)
were
identified by screening carried out at the hospital.
3 Monitoring of infected pregnant women
3.1 General obstetric and gynecological care
Consensus-based recommendation 3.E9
Expert consensus
Level of consensus +++
The care of a pregnant woman infected with SARS-CoV-2 should not deviate from obstetric standards and the specifications in the German Maternity Guidelines.
Consensus-based statement 3.S1
Expert consensus
Level of consensus +++
When planning elective prenatal appointments and examinations it is important to consider
whether they could be postponed until the pregnant woman no longer needs to isolate/is
no longer contagious.
3.2 Symptom-based care
3.2.1 Pregnant women who are asymptomatic or have only mild symptoms
Consensus-based recommendation 3.E10
Expert consensus
Level of consensus +++
A pregnant woman who is infected but asymptomatic or has only mild symptoms must be cared for in accordance with the recommended standards given elsewhere in the
guidelines for non-pregnant women. The risk of acute decompensation must be emphasized.
Note: We would like to explicitly refer to the recommendations of the S2e-guideline “SARS-CoV-2/COVID-19
Information & Practical Help for General Practitioners in Private
Practice” (as at 02/2022) [1 ].
3.2.2 Moderately ill pregnant women
Consensus-based recommendation 3.E11
Expert consensus
Level of consensus +++
If a pregnant woman has symptoms which clearly have a negative impact on her general
condition and/or is a higher risk patient in addition to her pregnancy (this particularly
applies to unvaccinated pregnant women and pregnant women with obesity, diabetes,
hypertension, or chronic lung disease), it must be established whether admission to
hospital is indicated.
Note: We would like to explicitly refer to the recommendations of the S2e-guideline “SARS-CoV-2/COVID-19
Information & Practical Help for General Practitioners in Private
Practice” (as at 02/2022) [1 ].
3.2.3 Severely ill pregnant women
Consensus-based statement 3.S2
Expert consensus
Level of consensus +++
When treating a patient in hospital for COVID-19 who is pregnant or has recently given
birth, treatment should follow the S3-guideline “Recommendations for the Inpatient
Treatment of Patients with COVID-19” and additionally focus on the obstetric aspects.
Consensus-based recommendation 3.E12
Expert consensus
Level of consensus +++
If admitted to hospital , the patientʼs vital signs (blood pressure, heart rate, respiratory rate, and oxygen
saturation) must be measured. In addition to taking
the patientʼs vital signs, laboratory and urine diagnostics must also be carried out.
Consensus-based recommendation 3.E13
Expert consensus
Level of consensus +++
The initial laboratory workup should include the following parameters which need to be checked regularly as necessary:
differential blood count, CRP, LDH, AST/ALT,
creatinine as well as D-dimer, prothrombin time, activated partial thromboplastin
time (aPTT), fibrinogen and urine diagnostics (proteinuria/albuminuria, hematuria,
leukocyturia).
Consensus-based recommendation 3.E14
Expert consensus
Level of consensus +++
Imaging must be carried out if the patient presents with respiratory insufficiency or there is
a suspicion of pulmonary embolism. This may require the use of procedures
employing ionizing radiation (e.g., X-rays/CT).
Consensus-based recommendation 3.E15
Expert consensus
Level of consensus +++
Measurement of vital signs and oxygen saturation must be carried out and the patient must be regularly checked to see whether admission
to an intensive care unit is
indicated. For patients with COVID-19 and acute hypoxemic respiratory failure, the
goal is to ensure adequate oxygenation. The aim must be to achieve SpO2
≥ 94%.
Outpatient treatment of SARS-CoV-2 infection/COVID-19
Admission to hospital for monitoring is recommended if symptoms worsen, the patient
reports subjective worsening, or vital signs are abnormal. The Modified Early Obstetric
Warning
Score MEOWS or a similar emergency-care scoring system can be a useful instrument
for an objective evaluation and to provide recommendations for action ([Table 5 ]). There are no published empirical data for COVID-19.
Table 5 Modified Early Obstetric Warning Score (MEOWS), taken from [41 ].
MEOW score
3
2
1
0
1
2
3
MEOWS 0 – 1: normal
MEOWS 2 – 3: stable , report findings to healthcare provider the same day
MEOWS 4 – 5: unstable , urgent evaluation by medical doctor
MEOWS ≥ 6: critical , immediate emergency care
SpO2 (%)
≤ 85
86 – 89
90 – 95
≥ 96
Respiratory rate (/min)
< 10
10 – 14
15 – 20
21 – 29
≥ 30
Pulse (/min)
< 40
41 – 50
51 – 100
101 – 110
110 – 129
≥ 130
Systolic blood pressure (mmHg)
≤ 70
71 – 80
81 – 100
101 – 139
140 – 149
150 – 159
≥ 160
Diastolic blood pressure (mmHg)
≤ 49
50 – 89
90 – 99
100 – 109
≥ 110
Diuresis (mL/h)
0
≤ 20
≤ 35
35 – 200
≥ 200
Central nervous system
agitated
awake
responds to verbal stimuli
responds to pain
no response
Temperature (°C)
≤ 35
35 – 36
36 – 37.4
37.5 – 38.4
≥ 38.5
3.3 Peripartum monitoring of infection
Consensus-based recommendation 3.E16
Expert consensus
Level of consensus +++
Constant monitoring must be carried out during the birth if the pregnant woman is infected with SARS-CoV-2
and must include the measurement of oxygen saturation,
with the aim of achieving SpO2 ≥ 94%. For further details, readers are explicitly referred to the recommendations
in Chapter 5 “Giving Birth”.
For the peripartum monitoring of a pregnancy, please refer to the recommendations
on giving birth and obstetric management in Chapter 5 “Giving birth when positive
for
COVID-19/SARS-CoV-2”.
3.4 Care after SARS-CoV-2 infection
For subsequent monitoring of the pregnancy after a SARS-CoV-2 infection, please refer
to Chapter 4.3 “Care in pregnancy after SARS-CoV-2 infection”.
For the post-COVID period, please refer to the relevant S1-guideline “Post-COVID/Long
COVID” (AWMF registry No. 020/027) [42 ].
4 Monitoring the fetus
4.1 General monitoring during maternal SARS-CoV-2 infection
Consensus-based recommendation 4.E17
Expert consensus
Level of consensus +++
In cases with maternal SARS-CoV-2 infection, fetal monitoring must adhere to current national guidelines and take account of the guidelines issued by
professional medical
societies on the use of ultrasound, Doppler and CTG, and biochemical analysis.
Monitoring the pregnancy and the fetus of mothers with (acute) SARS-CoV-2 infection
is done in accordance with general guidelines and medical guidelines and is based
on the respective
week of gestation [43 ], [44 ], [45 ], [46 ], [47 ], [48 ]. Setting up outpatient infection clinics in doctorʼs offices may make it easier
to implement guideline recommendations
[49 ]. Currently valid prenatal diagnostic methods which comply with these standards should
additionally be available [43 ], [50 ], [51 ], [52 ], [53 ], [54 ], [55 ], [56 ], [57 ]. When planning elective examinations,
postponing these examinations until the pregnant woman no longer needs to isolate/is
no longer contagious should be considered. The decision must be weighed up on a case-by-case
basis
which considers the risks, particularly during a pandemic in which it may sometimes
be more difficult to access healthcare [58 ].
4.2 Monitoring the fetus during maternal COVID-19 infection
Consensus-based recommendation 4.E18
Expert consensus
Level of consensus +++
Maternal monitoring of a pregnant woman who is seriously ill with COVID-19 is decisive
for the prognosis of the fetus. Monitoring must be stepped up if there are signs
that the motherʼs condition is worsening (she may imminently require artificial respiration
or ECMO). Acute respiratory decompensation must be expected and measures to
promptly deliver the unborn child must be discussed.
Consensus-based statement 4.S3
Expert consensus
Level of consensus +++
There is no evidence for an optimal fetal monitoring regimen in pregnant women infected
with SARS-CoV-2. There is no evidence which shows that more intensive fetal monitoring
would improve fetal outcome.
Acute pulmonary decompensation is characteristic of SARS-CoV-2 infection and has also
been observed in pregnant women whose previous course of pregnancy was unremarkable
[59 ], [60 ]. When monitoring a viable fetus, monitoring should include CTG examinations as well
as checking on fetal growth,
carrying out Doppler examinations, and monitoring the amniotic fluid to exclude placental
insufficiency as this can lead to FGR [61 ], [62 ].
4.3 Care in pregnancy after SARS-CoV-2 infection
Consensus-based recommendation 4.E19
Expert consensus
Level of consensus +++
A fetal assessment should be carried out if a pregnant woman is admitted to hospital and/or was treated for
COVID-19 after she has recovered: e.g., fetal biometry, fetal
arterial and venous Doppler, maternal Doppler (uterine arteries), Examinations should
look for visible signs of infection-related fetal damage, especially cerebral signs
of
hypoxia/stroke/porencephalic cysts.
Consensus-based recommendation 4.E20
Expert consensus
Level of consensus +++
Depending on the week of gestation of the pregnant woman with SARS-CoV-2 infection,
additional examinations must be carried out on a case-by-case basis due to the higher
risk of developing preeclampsia/FGR/vasculitis and the higher risk of preterm birth
(e.g., FTS or precise diagnostic workup).
The are no resilient data about the appropriate intervals for clinical monitoring.
For pregnant women who have recovered from a SARS-CoV-2 infection, had only slight,
moderate, or even no
symptoms and did not require admission to hospital, the RCOG recommends an unchanged
regimen of prenatal care after the pregnant woman no longer needs to self-isolate
[63 ]. In cases which take a severe course, maternal hypoxia involves a risk of fetal
hypoxic damage [59 ], [60 ]. It is therefore important that a fetal assessment is carried out at the end of
any hospital treatment for COVID-19 or after severe maternal illness, which
considers the clinical circumstances and manifestations of COVID-19 in the pregnant
woman.
Depending on the extent and type of symptoms of SARS-CoV-2 infection/COVID-19, the
risk of pregnancy-related conditions such as preeclampsia [33 ], [64 ], [65 ], [66 ], [67 ], [68 ], [69 ] and preterm birth [15 ], [68 ] – [74 ] is
higher. A number of studies have reported a higher rate of stillbirths [33 ], [68 ], [75 ] and
placental changes such as intervillous inflammation, focal vascular villitis and clot
formation in fetal vessels [76 ], [77 ], [78 ], [79 ], [80 ]. However, these often unspecific changes are not universally
demonstrable [80 ], [81 ].
5 Giving birth when positive for COVID-19/SARS-CoV-2
5.1 Birth companion during the birth
Consensus-based recommendation 5.E21
Expert consensus
Level of consensus +++
Women giving birth who have tested negative for SARS-CoV-2 (at least one rapid antigen
test within the previous 24 h) or whose infectious status is not yet clear but who
have no
symptoms (e.g., results of the PCR test have not come back yet) must be permitted to have a birth companion during the birth.
Consensus-based recommendation 5.E22
Expert consensus
Level of consensus +++
For reasons of infection control, it is not recommended that women giving birth who
have tested positive for SARS-CoV-2 or have symptoms of COVID-19 have a birth companion.
Should it nevertheless be necessary in individual cases (e.g., difficulties in communicating
with the woman giving birth), the birth companion must have either recovered
from SARS-CoV-2, be vaccinated against SARS-CoV-2 or have tested negative for SARS-CoV-2.
The birth companion must be given suitable protective clothing and comply with
protection measures.
Consensus-based recommendation 5.E23
Expert consensus
Level of consensus +++
Any birth companion must be asymptomatic and have no SARS-CoV-2 infection (at least one negative SARS-CoV-2
antigen test within the previous 24 h before entering the
delivery ward). If possible, the birth companion must not leave the room where the pregnant woman is giving birth and must comply with the existing hygiene
regulations such as the wearing of a FFP.
5.2 Induction of labor and monitoring of the birth
Consensus-based recommendation 5.E24
Expert consensus
Level of consensus +++
A SARS-CoV-2 infection or development of COVID-19 must not , by itself, constitute a reason to deliver the unborn child.
Consensus-based recommendation 5.E25
Expert consensus
Level of consensus +++
If relevant maternal respiratory or general impairments are present, the indication
to deliver the infant should be reviewed regularly based on the gestational age and
the severity of maternal impairment. This implies that close clinical monitoring of
the mother and unborn child must be carried out regularly and include monitoring fetal
vitality as well as interdisciplinary visits by medical staff from the specialist
disciplines involved in the care of mother and child.
Consensus-based recommendation 5.E26
Expert consensus
Level of consensus +++
All specialist disciplines and professions involved in or present at the birth (medical
specialties, nursing care, midwives, obstetrics, anesthesiology, pediatric medicine,
etc.) must be informed at an early stage that a woman with SARS-CoV-2 infection or COVID-19
disease will soon be giving birth as this will make it possible to implement
the necessary protection measures effectively in an emergency.
5.3 Delivery mode for women with SARS-CoV-2
Consensus-based recommendation 5.E27
Expert consensus
Level of consensus +++
Even if the mother has a SARS-CoV-2 infection or COVID-19 disease, the delivery mode
should be chosen based on obstetric criteria.
Consensus-based statement 5.S4
Expert consensus
Level of consensus +++
In addition to the motherʼs medical condition and assumed infectiousness, the decision
on the appropriate birth mode must also take account of logistical conditions, the
available rooms, and available staff at the hospital.
Consensus-based recommendation 5.E28
Expert consensus
Level of consensus +++
If the clinical condition of the pregnant woman worsens during spontaneous vaginal
delivery, changing the birth mode should be considered.
5.4 Analgesia during delivery
Consensus-based recommendation 5.E29
Expert consensus
Level of consensus +++
If the pregnant woman with SARS-CoV-2 infection or COVID-19 disease requests analgesia,
she must be offered neuraxial analgesia (e.g., epidural analgesia) at an early
stage.
Consensus-based recommendation 5.E30
Expert consensus
Level of consensus +++
Because of the increased aerosol formation, the use of nitrous oxide (N2 O) should be avoided when caring for a parturient woman with SARS-CoV-2 infection or
COVID-19 disease in favor of other available alternatives such as neuraxial analgesia.
Consensus-based recommendation 5.E31
Expert consensus
Level of consensus +++
Because of the potential respiratory depression effect, continuous monitoring of SARS-CoV-2-positive
patients (1 : 1 care) must be carried out if opioids, particularly
remifentanil, are administered, including monitoring the oxygen saturation with the
aim of ensuring an oxygen saturation of at least 94% (SpO2 ≥ 94%).
6 Neonates: rooming-in, breastfeeding and testing
Consensus-based recommendation 6.E32
Expert consensus
Level of consensus +++
Rooming-in and bonding with a mother who has tested positive for SARS-CoV-2/has developed
COVID-19 should be supported subject to adequate hygiene measures.
Consensus-based recommendation 6.E33
Expert consensus
Level of consensus +++
Women who are positive for SARS-CoV-2/have COVID-19 disease must be supported to breastfeed. Special hygiene measures should be observed. If the health of the mother
or infant does not permit breastfeeding, the goal should be to use expressed breastmilk to feed the infant.
Consensus-based statement 6.S5
Expert consensus
Level of consensus +++
It is not necessary to test the breastmilk for SARS-CoV-2 virus.
Consensus-based recommendation 6.E34
Expert consensus
Level of consensus +++
General screening of asymptomatic neonates who do not require special neonatal care born to mothers
with SARS-CoV-2 infection/COVID-19 disease must not be carried
out.
Consensus-based recommendation 6.E35
Expert consensus
Level of consensus +++
Testing for SARS-CoV-2 in a neonate not requiring neonatal care may be carried out if, for example, it can be assumed that the mother is contagious.
The SARS-CoV-2
test must be carried out using a nasopharyngeal RT-PCR test.
Consensus-based statement 6.S6
Expert consensus
Level of consensus +++
If a test is carried out to exclude intrauterine transmission, then it must be carried
out within 24 h post partum. It is important to be aware that if testing is done immediately
after the birth, it may result in a false-positive result due to transient contamination
by maternal secretions.
Consensus-based recommendation 6.E36
Expert consensus
Level of consensus +++
Irrespective of any neonatal or maternal symptoms, a neonate requiring neonatal care with evidence of maternal peripartum SARS-CoV-2/maternal contagiousness
must be
tested for SARS-CoV-2 using a RT-PCR test on admission. During the time the infant
is kept in neonatal intensive care or in a peripheral ward, a PCR test should be carried
out on the 3rd day and repeated on the 5th day of treatment due to an average incubation
period of 4 – 5 days. The isolation period should be agreed on a case-by-case basis
with the local hygiene team.
Vertical transmission of SARS-CoV-2 may occur antenatally, during the birth, or postnatally
[82 ]. Intrauterine transmission appears to be possible at any
time during pregnancy [82 ], [83 ], [84 ] but it has only been reported in isolated cases with
severe maternal disease [85 ], [86 ], [87 ]. Transmission to the neonate during the birth through
maternal aerosols or fecal contamination of the birth canal is possible in cases of
acute maternal SARS-CoV-2 infection (from 14 days before to 2 days after the birth,
in very rare cases
even when the infection did not occur recently [82 ], [88 ], [89 ], [90 ].
The professional medical associations which agreed upon and voted for these recommendations
explicitly support both immediate contact between mother and child and breastfeeding,
as long as
appropriate hygiene measures are followed [3 ], [91 ] – [95 ]. Hygiene measures are summarized in
[Table 6 ].
Table 6 Hygiene measures.
Hygiene measures during rooming-in/breastfeeding for mothers who have tested positive
for SARS-CoV-2
Wear FFP during close contact (bonding, breastfeeding)
Avoid mucosal contact: e.g., no kisses
Practice hand hygiene (disinfect or wash with soap for at least 20 sec.) prior to
having any contact with the newborn infant
Practice breast hygiene before breastfeeding
Ensure a distance of 1.5 meters if the mother and child share the same room (e.g.,
between the newborn infantʼs cot and the motherʼs bed) OR place a mobile divider
When expressing milk:
pasteurizing the milk is not necessary
the milk should be given by a (accompanying) person who has tested negative for SARS-CoV-2,
where possible
the mother should be assigned her own breast pump.
General testing of all neonates born to mothers positive for SARS-CoV-2 does not offer
any guaranteed benefits [96 ], [97 ].
The course of neonatal SARS-CoV-2 infections is almost always unproblematic [86 ], [93 ], [98 ]
and often (in 45% of cases, according to a meta-analysis of 176 neonates) asymptomatic
[86 ]. But testing for SARS-CoV-2 may be carried out for other reasons,
for example, for epidemiological reasons or to allow the removal of isolation measures.
As is done in adults and children, a swab taken from around the respiratory tract
(nasopharyngeal,
oropharyngeal, nasal area) is suitable for RT-PCR testing [91 ], [95 ], [98 ]. There are no other
laboratory parameters specific to SARS-CoV-2 infection. Leukopenia, lymphocytopenia
and thrombocytopenia have been observed, as have elevated transaminase levels; CRP
and procalcitonin are
usually in normal ranges in neonates [99 ]. A differential diagnosis may be considered and appropriate examinations carried
out if the neonate presents with
symptoms [95 ].
A possible care algorithm for neonates born to mothers who tested positive for acute
SARS-CoV-2 compiled by the DGPI, DGPM und DGGG and published in March 2020 has proved
to be useful
during the pandemic and is shown in [Fig. 1 ]
[91 ].
Abb. 1 Possible care algorithm for neonates born to mother who have tested positive for
acute SARS-CoV-2 according to the extent of disease of mother and child. [rerif]
7 Thromboprophylaxis
Consensus-based recommendation 7.E37
Expert consensus
Level of consensus +++
The following parameters must be considered when deciding whether VTE prophylaxis during pregnancy/puerperium of
women with SARS-CoV-2 infection/COVID-19 is indicated:
Dynamics of the symptoms of disease (asymptomatic, mild, severe)
The care situation (outpatient vs. inpatient)
The individual VTE risk (pre-existing/acquired factors)
Consensus-based recommendation 7.E38
Expert consensus
Level of consensus +++
If a pregnant woman with asymptomatic SARS-CoV-2 infection and no additional VTE risk factors is receiving outpatient care, she must not be given
anticoagulants.
Consensus-based statement 7.S7
Expert consensus
Level of consensus +++
References: [63 ], [100 ]
In addition to the above-mentioned recommendations for an individual VTE risk assessment,
a points system can be used for patients treated in an outpatient setting (e.g., please
refer to the guideline 015/092 published at the webside of the AWMF or the RCOG Green
Top Guideline 37a). A SARS-CoV-2 infection would be categorized as “systemic infection”
even
though SARS-CoV-2 infection was not anticipated at the time when the points system
was compiled.
Consensus-based recommendation 7.E39
Expert consensus
Level of consensus +++
All pregnant women admitted to hospital with SARS-CoV-2/COVID-19 must receive prophylactic medication against thromboembolisms and medication should be
continued as
long as symptoms continue, unless medication is contraindicated.
Consensus-based recommendation 7.E40
Expert consensus
Level of consensus +++
If thromboprophylaxis is indicated, it must be done using low molecular weight heparin (LMWH).
Unfractionated heparin may be used in an intensive care setting.
Thrombocyte aggregation inhibitors should not be used for thromboprophylaxis.
Consensus-based recommendation 7.E41
Expert consensus
Level of consensus +++
If thromboprophylaxis is indicated due to COVID-19 it should be continued until the patient has no more symptoms.
Consensus-based statement 7.S8
Expert consensus
Level of consensus +++
There is no evidence that thromboprophylaxis only because of COVID-19 should be continued
after the patient no longer has COVID-19 symptoms.
Irrespective of any SARS-CoV-2 infection, the risk of venous thromboembolism (VTE)
is higher during pregnancy, increases with increasing gestational age, and is at its
highest in the first
2 weeks after the birth. The risk of VTE is 2 times higher in the first and second
trimester of pregnancy, 9 times higher in the third trimester, and 60 – 80 times higher
in the first 2 to 6
weeks after the birth compared to non-pregnant women [101 ], [102 ].
Irrespective of whether a woman is pregnant or not, systemic microangiopathies and
thromboembolisms are particularly likely to develop if a woman has severe COVID-19
[103 ], [104 ]. Direct obstetric data about the risk of venous thromboembolisms combined with SARS-CoV-2/COVID-19
are limited but
they do appear to indicate an additional higher risk for infected pregnant women compared
to non-infected pregnant women (0.2 vs. 0.1%; aOR 3.4, 95% CI: 2.0 – 5.8) [105 ], [106 ], [107 ], [108 ].
The indication for VTE prophylaxis in pregnancy/puerperium for women with SARS-CoV-2
infection/COVID-19 is cumulatively justified based on 3 parameters:
The dynamics of the symptoms of disease: asymptomatic, mild, moderate, severe, critical
The care situation: outpatient or inpatient
The individual risk of VTE: pre-existing and acquired risk factors
The decision whether to continue VTE prophylaxis for pregnant women or postpartum
patients on discharge must be made on a case-by-case basis which also considers additional
existing VTE
risk factors and the patientʼs obstetric course. While COVID-19 is assumed to be a
transient risk factor, continuing with VTE prophylaxis medication after COVID symptoms
are no long present
appears to be appropriate.
As regards the decision to administer anticoagulants in an inpatient setting, please
also refer to the German-language AWMF S3-guideline “Recommendations for the Inpatient
Treatment of
Patients with COVID-19” [2 ].
Recommendations for VTE prophylaxis based on the individual care situation and the
specific risk factors at different obstetric timepoints are summarized in [Fig. 2 ]
[3 ].
Abb. 2 Recommendations on VTE prophylaxis for pregnant women/women who have recently given
birth with SARS-CoV-2 infection/COVID-19 based on the situation, symptoms and
individual risk factors (from [3 ]). [rerif]
The Royal College of Obstetrics and Gynaecology has published a detailed schematic
scoring system to support decisions when to administer anticoagulants to pregnant
women and women who have
recently given birth in its Green Top Guideline 37a [100 ]. In their guideline, SARS-CoV-2 infection is modelled as a transient risk factor
under the heading
“systemic infection”, even though SARS-CoV-2 infection could not have been anticipated
at the time when the scoring system was compiled. The scoring system is shown in the
long version of
this guideline.
8 Drug therapy for SARS-CoV-2 infection
8.1 Use of corticosteroids during SARS-CoV-2 infection
8.1.1 Systemic antenatal administration of corticosteroids for fetal indications
Consensus-based recommendation 8.E42
Expert consensus
Level of consensus +++
A pregnant woman with SARS-CoV-2 infection must be given antenatal steroids for fetal indications if she shows signs of clinical
worsening (e.g., intubation/ECMO is
planned) between weeks 23 + 5 and 34 + 0 of gestation (2 × 12 mg betamethasone/celestan
administered intramuscularly (IM) with an interval of 24 h between doses);
alternatively, the patient may be treated with dexamethasone (IM) 4 × 6 mg every 12 h.
It is currently not possible to answer the question whether betamethasone is equivalent
to dexamethasone with regards to COVID-19.
8.1.2 Systemic corticosteroid administration to treat COVID-19
Consensus-based recommendation 8.E43
Expert consensus
Level of consensus +++
If maternal corticosteroid therapy is indicated due to maternal COVID-19 symptoms,
an assessment must be made at the same time whether antenatal administration of
steroids is required for fetal indications.
Consensus-based recommendation 8.E44
Expert consensus
Level of consensus +++
The indications to administer corticosteroids to pregnant women with SARS-CoV-2 infection
must be the same as those for non-pregnant women.
Consensus-based recommendation 8.E45
Expert consensus
Level of consensus +++
If a pregnant woman with SARS-CoV-2 infection is administered corticosteroids based
on the AWMF S3-guideline 113/001, consideration must be given to replacing
dexamethasone with prednisolone or hydrocortisone as they do not cross the placenta
as much and have fewer side effects on the fetus (6 mg dexamethasone/24 h oral/IV
≙ 40 mg
prednisolone/24 h oral ≙ 2 × 80 mg hydrocortisone/24 h IV).
8.1.3 Inhalative corticosteroids
In the S2e-guideline “SARS-CoV-2/Covid-19 Information & Practical Help for General
Practitioners in Private Practice”, the German Society for General and Family Medicine
(Deutsche
Gesellschaft für Allgemeinmedizin und Familienmedizin e. V.) recommends that “patients
with SARS-CoV-2 infection who are at risk of severe course of disease may be offered
budesonide
inhalation (2 × 800 µg/d for 7 – 14 days) to reduce this risk (off-label therapy)”
[1 ].
8.2 Antiviral or COVID-19-specific drugs
For treatment regimens and drug-based treatment options, please refer to the German-language
S3-guideline with the AWMF registry no. 113/001 “Recommendations for the Inpatient
Treatment
of Patients with COVID-19” [2 ] as well as the statements “Antiviral Medicinal Products for the Treatment of COVID-19”
[109 ]
and “COVID-19 Pre-exposition Prophylaxis” [110 ] issued by the Commission “Benefit Assessment of Medicinal Products”. The recommendations
are based on the
RCOG guideline “Coronavirus (COVID-19) Infection in Pregnancy” [63 ] and the guideline of the WHO “Therapeutics and COVID-19: Living Guideline” [111 ] and are summarized in [Table 7 ].
Table 7 Specific COVID-19 medications in pregnancy.
Specific medication for COVID-19
Data basis/recommendations for use
Sotrovimab, casirivimab/imdevimab, tixagevimab/cilgavimab (neutralizing monoclonal
antibodies)
No associated increased risk of adverse pregnancy outcomes. Data are limited; therefore,
no final assessment can be made [63 ], [111 ], [112 ], [113 ], [114 ], [115 ], [116 ], [117 ].
Remdesivir (antiviral medicine)
WHO and RCOG recommend that it should be avoided in pregnancy. But because of the
low rates of adverse events, administering the drug may be considered if the patient
shows
signs of clinical deterioration [63 ], [111 ], [118 ], [119 ].
Tocilizumab (interleukin-6 receptor inhibitor)
Only limited data available. No indications of teratogenicity or fetotoxicity [63 ], [111 ], [120 ], [121 ], [122 ], [123 ].
Molnupiravir (antiviral medicine)
Should not be prescribed [111 ].
Nirmatrelvir/ritonavir (Paxlovid, protease inhibitors)
No data on the use of these medications in pregnancy. Must only be administered if
potential benefit is clear [124 ], [125 ].
9 Vaccinations in Pregnancy
The Standing Commission on Vaccination at the RKI (STIKO) recommends that all unvaccinated
persons of childbearing age should be vaccinated against COVID-19 to ensure that they
already have
optimum protection against the disease before the start of any pregnancy. The recommendation
is that pregnant women who have not yet been vaccinated should receive a vaccination
consisting
of two doses of a COVID-19 mRNA vaccine, with an interval of 3 – 6 weeks between vaccinations
(Comirnaty) from the 2nd trimester of pregnancy. If the pregnancy was only detected
after the
first vaccination, the second vaccination should only be administered from the 2nd
trimester of pregnancy. In addition, the STIKO recommends that unvaccinated breastfeeding
mother should be
vaccinated with two doses of an mRNA vaccine, with an interval of 3 – 6 weeks between
vaccinations (Comirnaty) (as at 16.09.2021). The recommendations regarding booster
vaccinations for
pregnant women also apply (as at 15.02.2022) [126 ], [127 ]. In this context, please refer to the very detailed
German-language “Justification of the STIKO for the Vaccination of Pregnant and Breastfeeding
Women against COVID-19” [128 ].
The guideline authors agree with the recommendations of the STIKO.
