SARS-CoV-2 in Pregnancy, Birth and Puerperium. Guideline of the DGGG and DGPM (S2k-Level, AWMF Registry Number 015/092, March 2022)

Abstract

Objective This S2k guideline of the German Society for Gynecology and Obstetrics (DGGG) and the German Society of Perinatal Medicine (DGPM) contains consensus-based recommendations for the care and treatment of pregnant women, parturient women, women who have recently given birth, and breastfeeding women with SARS-CoV-2 infection and their newborn infants. The aim of the guideline is to provide recommendations for action in the time of the COVID-19 pandemic for professionals caring for the above-listed groups of people.

Methods The PICO format was used to develop specific questions. A systematic targeted search of the literature was carried out using PubMed, and previously formulated statements and recommendations issued by the DGGG and the DGPM were used to summarize the evidence. This guideline also drew on research data from the CRONOS registry. As the data basis was insufficient for a purely evidence-based guideline, the guideline was compiled using an S2k-level consensus-based process. After summarizing and presenting the available data, the guideline authors drafted recommendations in response to the formulated PICO questions, which were then discussed and voted on.

Recommendations Recommendations on hygiene measures, prevention measures and care during pregnancy, delivery, the puerperium and while breastfeeding were prepared. They also included aspects relating to the monitoring of mother and child during and after infection with COVID-19, indications for thrombosis prophylaxis, caring for women with COVID-19 while they are giving birth, the presence of birth companions, postnatal care, and testing and monitoring the neonate during rooming-in or on the pediatric ward.

 

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Key words

coronavirus - COVID-19 - obstetrics - neonatology - midwifery

I  Guideline Information

Guidelines program of the DGGG, OEGGG and SGGG

For information on the guidelines program, please refer to the end of the guideline.

 

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Citation format

SARS-CoV-2 in Pregnancy, Birth and Puerperium. Guideline of the DGGG and DGPM (S2k-Level, AWMF Registry Number 015/092, March 2022). Geburtsh Frauenheilk 2023. doi:10.1055/a-2003-5983

 

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Guideline documents

The complete long version of this guideline in German as well as a list of the conflicts of interest of all the authors is available on the the homepage of the AWMF: http://www.awmf.org/leitlinien/detail/ll/015-092.html

 

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Guideline authors

See [Tables 1] and [2].

Table 1 Lead and/or coordinating guideline author.

Author	AWMF professional society
Prof. Dr. Ulrich Pecks	German Society of Perinatal Medicine, DGPM
Prof. Dr. Frank Louwen	German Society of Gynecology and Obstetrics/Working Group for Obstetrics and Prenatal Medicine, DGGG/AGG

Table 2 Contributing guideline authors.

Author Mandate holder	DGGG working group (AG)/AWMF/non-AWMF professional society/organization/association
* These persons contributed significantly to the development of the guideline. They did not vote on recommendations or statements.
Lena Agel	German Society of Midwifery Science, DGHWi
Dr. Klaus J. Doubek	Professional Association of Gynecologists, BVF
Dr. Carsten Hagenbeck	German Society of Gynecology and Obstetrics/Working Group for Obstetrics and Prenatal Medicine, DGGG/AGG
Prof. Dr. Constantin von Kaisenberg	German Society of Ultrasound in Medicine and Biology, DEGUM
Prof. Dr. Peter Kranke	German Society of Anesthesiology and Intensive Care Medicine, DGAI
Sabine Leitner	Professional Association “The preterm infant” [Bundesverband „Das frühgeborene Kind“]
Dr. Nadine Mand	Society for Neonatology and Pediatric Intensive Care Medicine, GNPI
Prof. Dr. Mario Rüdiger	German Society of Perinatal Medicine, DGPM
Dr. Janine Zöllkau	German Society for Prenatal and Obstetric Medicine, DGPGM
Dr. Lukas Jennewein*	Frankfurt University Hospital
Nina Mingers*	Schleswig-Holstein University Hospital
Magdalena Sitter*	Würzburg University Hospital

The following professional societies/working groups/organizations/associations stated that they wished to contribute to the guideline text and participate in the consensus conference and nominated representatives to contribute and attend the conference ([Table 2]).

Neutral moderation of the guideline was provided by Prof. Dr. Constantin von Kaisenberg (certified AWMF-guidelines consultant).

 

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Abbreviations

ALT: alanine aminotransferase

aPPT: activated partial thromboplastin time

AST: aspartate aminotransferase

CCP: clinical consensus point

CGP: good clinical practice

CRP: C-reactive protein

CT: computed tomography

CTG: cardiotocography

EC: expert consensus

ECMO: extracorporeal membrane oxygenation

FFP: filtering facepiece

FGR: fetal growth restriction

FTS: first trimester screening

IM: intramuscular

IV: intravenous

LDH: lactate dehydrogenase

LMWH: low molecular weight heparin

MEOWS: modified early obstetric warning score

PCR: polymerase chain reaction

RKI: Robert Koch Institute

RT-PCR: real-time polymerase chain reaction

SpO₂ : oxygen saturation

STIKO: ständige Impfkommission/Standing Committee on Vaccination at the RKI

VTE: venous thromboembolism

WHO: World Health Organization
 

 

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II  Guideline Application

Purpose and objectives

The purpose of this guideline is to provide recommendations for action with regards to the care of pregnant women, parturient women, women who have recently given birth, and breastfeeding women and their newborn infants during and after infection with SARS-CoV-2 while also considering the available evidence (which was limited, due to the newness of the virus) as well as own data from the CRONOS registry.

 

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Targeted areas of care

• Inpatient care

• Outpatient care

 

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Target user groups/target audience

This guideline aims to provide all persons involved in the care of pregnant women, parturient women, women who have recently given birth, and breastfeeding women with SARS-CoV-2 infection with recommendations for action. The guideline is aimed at:

• gynecologists/obstetricians

• pediatricians/neonatologists (m/w/d)

• anesthesiologists

• midwives

• nurses and orderlies working in maternity wards and pediatric wards caring for newborn babies

 

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Adoption and period of validity

The validity of this guideline was confirmed by the executive boards/representatives of the participating medical professional societies/working groups/organizations/associations as well as by the board of the DGGG and the DGPM as well as by their Guidelines Commissions in March 2022 and was thereby approved in its entirety. This guideline is valid from 1 March 2022 through to 31 March 2025. Because of the contents of this guideline, this period of validity is only an estimate. The guideline can be reviewed and updated earlier if necessary. If the guideline still reflects the current state of knowledge, its period of validity can be extended.

 

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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

 

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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

 

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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.

 

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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

 

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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”).

 

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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):

1. 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

2. 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

3. 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

4. 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].

5. 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.

 

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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.

 

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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]

 

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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.

 

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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].

 

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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.

 

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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.

 

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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].

 

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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].

 

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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

 

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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”.

 

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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].

 

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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].

 

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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].

 

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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].

 

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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.

 

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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.

 

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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.

 

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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 (N2O) 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%).

 

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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]

 

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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.

 

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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.

 

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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).

 

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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].

 

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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].

 

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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.

 

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Conflict of Interest/Interessenkonflikt

The authorsʼ conflicts of interest are listed in the long version of the guideline./Die Interessenkonflikte der Autoren sind in der Langfassung der Leitlinie aufgelistet.

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Publication History

Received: 08 December 2022

Accepted: 14 December 2022

Article published online:
09 March 2023