Journal Pre-proof

Fetal Interventions in the Setting of COVID-19 Pandemic: Statement from the North
American Fetal Therapy Network (NAFTNet)

Mert Ozan Bahtiyar, Ahmet Baschat, Jan Deprest, Stephen Emery, William
Goodnight, Anthony Johnson, Laurence McCullough, Julie Moldenhauer, Greg Ryan,
KuoJen Tsao, Tim Van Mieghem, Amy Wagner, Michael Zaretsky, on behalf of
NAFTNet

PII: S0002-9378(20)30473-7
DOI: https://doi.org/10.1016/j.ajog.2020.04.025
Reference: YMOB 13218

To appear in: American Journal of Obstetrics and Gynecology

Received Date: 5 April 2020

Revised Date: 20 April 2020
Accepted Date: 22 April 2020

Please cite this article as: Bahtiyar MO, Baschat A, Deprest J, Emery S, Goodnight W, Johnson A,
McCullough L, Moldenhauer J, Ryan G, Tsao K, Van Mieghem T, Wagner A, Zaretsky M, on behalf of
NAFTNet, Fetal Interventions in the Setting of COVID-19 Pandemic: Statement from the North American
Fetal Therapy Network (NAFTNet), American Journal of Obstetrics and Gynecology (2020), doi: https://
doi.org/10.1016/j.ajog.2020.04.025.

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1 Fetal Interventions in the Setting of COVID-19 Pandemic: Statement from the North American

2 Fetal Therapy Network (NAFTNet)

3
4 April 20, 2020
5
6
7
8 Mert Ozan Bahtiyar1, Ahmet Baschat2, Jan Deprest3, Stephen Emery4, William Goodnight5,
9 Anthony Johnson6, Laurence McCullough7, Julie Moldenhauer8, Greg Ryan9, KuoJen Tsao6, Tim
10 Van Mieghem9, Amy Wagner10, Michael Zaretsky11 on behalf of NAFTNet.
11
1
12 Yale Fetal Care Center, Yale University School of Medicine, CT, 2Johns Hopkins Center for
13 Fetal Therapy, Baltimore, MD, 3University Hospitals Leuven, Leuven Belgium & University
14 College London Hospital, London, UK 4University of Pittsburgh, Pittsburgh, PA, 5University of
15 North Carolina Health Fetal Care Center, Chapel Hill, NC, 6University of Texas Health Center,
16 Houston, TX, 7Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York,
8
17 Children's Hospital of Philadelphia, Philadelphia, PA, 9Ontario Fetal Centre, Mount Sinai
18 Hospital, University of Toronto, ON,10Children's Hospital of Wisconsin Fetal Concerns Center,
19 Milwaukee, WI, 11Colorado Fetal Care Center, Denver, CO.
20

21

22

23 Conflicts of interest: None of the authors report a conflict of interest for this manuscript.

24 Corresponding author:

25 William Goodnight, MD, MSCR

26 Department of Obstetrics and Gynecology
27 University of North Carolina School of Medicine
28 3010 Old Clinic Building, CB # 7516
29 Chapel Hill, NC 27599
30 william_goodnight@med.unc.edu
31 919-966-1601
32

33 Word count abstract: 105

34 Word count manuscript: 1121

35 Condensation: The COVID-19 2020 pandemic has impacted the provision of antenatal care,

36 requiring less urgent care to be deferred. Many fetal interventions are time sensitive and should

37 not be considered ‘elective’ once they can be performed using available local resources.

38

39

40

41

42 Short title: Fetal Interventions and COVID-19

43
44 Key words: fetal therapy, COVID-19, SARS-CoV-2, prenatal diagnosis, fetal intervention
45 As health care providers (HCPs) for pregnant women and their fetuses, we have been challenged

46 to balance the risks and benefits of care provision, as we adapt our established practice in the

47 setting of the COVID-19 (SARS-CoV-2 infection) pandemic1, 2. The risks include: the

48 interventional risk to the fetus and mother, treatment-related COVID-19 exposure to the HCP,

49 the impact on maternal and fetal health of procedures done in the setting of maternal COVID-19

50 infection, and the risks of not intervening in a timely manner on fetal and/or neonatal outcome1.

51

52 In an effort to balance these risks and to continue providing evidence-based fetal interventions

53 that reduce fetal morbidity and mortality, the North American Fetal Therapy Network

54 (NAFTNet, https://www.naftnet.org) suggests the following approach to fetal interventions in the

55 setting of COVID-19.* Prenatal care should be adjusted by optimizing appointment intervals,

56 patient self-assessment, such as home blood pressure monitoring, and the use of virtual

57 consultations2, 3. The gestational age dependent nature of reproductive choice and the

58 availability of effective interventions that can reduce fetal and neonatal morbidity and mortality

59 make prenatal diagnosis and most established fetal therapies time sensitive, the delay of which

60 may worsen perinatal outcome 4. These procedures should therefore not be defined as “elective”

61 and their provision should be guided by local institutional policies and practices in the context of

62 resource availability.

63

64
65 NAFTNet suggests the following specific considerations related to fetal interventions.

66

67 1. Due to the life-threatening, morbidity-related, and/or time-sensitive nature of conditions

68 requiring intervention, most fetal procedures are not “elective”. These include, but are not

69 limited to:

70 a. Fetal blood transfusions

71 b. Interventions for complicated monochorionic multiple gestations, including

72 fetoscopic placental laser surgery or selective reduction.

73 c. Shunting procedures for conditions with significant fetal compromise, such as

74 hydropic hydrothoraces or cystic lung lesions.

75 d. Open fetal surgical procedures, that are not experimental or under research

76 protocols, such as, but not limited to, open maternal-fetal surgery for fetal

77 myelomeningocele repair and ex-utero intra-partum therapy (EXIT) for

78 anticipated neonatal airway compromise.

79 2. The above recommendations should apply regardless of a patient’s COVID-19 status.

80 The decision to intervene may be influenced by the maternal condition. Maternal health

81 always takes priority over fetal status.

82 3. The limited evidence to date regarding the risk of vertical transmission of COVID-19

83 through fetal intervention should be included in the informed consent discussion prior to

84 such procedures.

85 4. Fetal therapists always strive to avoid trans-placental passage of our needle or

86 (particularly) fetoscope or shunt trocar, which becomes particularly pertinent when there

87 is a potential risk of maternal-fetal viral transmission. An exception might be fetal

 88 transfusion into an anterior placental cord insertion, if the fetal intra-hepatic vein was

89 inaccessible. Open fetal surgical procedures may carry a higher risk of such transmission.

90 5. General anesthesia is a high-risk procedure for viral transmission. The anesthetic risks,

91 and that of horizontal transmission of COVID-19 to HCPs, should be discussed between

92 the patient and her HCPs5. Procedures that violate the aero-digestive mucosa and/or

93 result in body fluid aerosolization are associated with COVID-19 transmission 5. Most

94 fetal procedures can be performed under conscious sedation and local anesthesia, which

95 reduces maternal risk and COVID-19 exposure risk to HCPs.

96 6. Appropriate PPE must be worn for all encounters with COVID-19 positive or PUI

97 (Person Under Investigation) patients. This applies for any potentially aerosolizing

98 procedures, including endotracheal intubation for general anesthesia or neonatal

99 intubation 2,5.

100 7. Equipment, including ultrasound machines, must be cleansed thoroughly between

101 patients, especially if COVID-19 positive, following stringent cleansing protocols 6.

102 8. Only essential HCPs should participate in procedures on COVID-19 positive or PUI

103 patients.

104 9. All non-essential personnel should limit direct patient contact. Whenever possible, patient

105 encounters, e.g. sub-specialty consultation or result follow-up, should be conducted

106 virtually 3. Dedicated fetal therapy nursing and care co-ordination remain critical

107 components of the fetal care team.

108 10. The potential exacerbation of known or unrecognized maternal COVID-19 infection,

109 which could result in increased fetal or maternal morbidity or mortality with any
110 intervention, must be considered. Where appropriate, infectious disease consultation

111 should be entertained.

112 11. Decisions should be made based on local medical, operational and organizational

113 considerations, influenced by local COVID-19 burden. Parents should be informed that

114 treatment availability may change at short notice, due to local healthcare adjustments as

115 they adapt to evolving pandemic trends.

116 12. Pre-operative COVID-19 testing for patients undergoing fetal interventions should follow

117 local policies and guidelines, according to access to testing and result response time. For

118 patients who test positive or are symptomatic, procedures should be delayed for 14 days,

119 or until patients meet local criteria for disease resolution. If the fetal condition requires

120 immediate intervention, and if the mother is stable, the procedure should be performed

121 using appropriate personal protective equipment (PPE).

122 13. Practice guidelines for procedures during the COVID-19 pandemic are continually

123 evolving as information emerges. NAFTNet will closely monitor emerging evidence and

124 will update our guidelines accordingly (https://www.naftnet.org).

125 14. All interventional research protocols should be suspended during the pandemic. No

126 clinical benefit for the fetus or newborn is lost, because the experimental outcomes are

127 unknown. However, we encourage recruitment of pregnant women and neonates with

128 COVID-19 infection into registries which may clarify the risk of vertical transmission

129 (Table 1).

130 15. Fetal therapy centers must carefully consider whether they can still offer certain, highly

131 resource intensive, fetal procedures, if their staffing becomes depleted, either due to

132 illness or deployment to other intensive care areas. In regions with multiple fetal therapy
133 programs, this may be a time for collaboration, volume reduction, and/or referral of

134 certain cases.

135 16. Patients traveling between states, provinces or countries should be counselled that, by

136 such travel, they may expose themselves to a higher risk of COVID-19 infection. They

137 may also become obliged to remain at their destined center for an unpredictable period of

138 time. After some procedures, patients may return earlier than usual to their referring

139 HCPs, for ongoing monitoring and care. Fetal therapy centers should remain engaged

140 with the referring HCP by phone or telemedicine. If travel restrictions are implemented,

141 patients who need to travel to a distant fetal therapy center may require supporting

142 documentation. Some centers may decline to accept patients who are either COVID-19

143 positive or who come from regions with a high infection prevalence.

144

145 NAFTNet’s suggested approach to the fetus, in the setting of the COVID-19 pandemic,

146 emphasizes the need for a comprehensive multi-disciplinary approach to maternal-fetal care. We

147 must carefully weigh the risks and benefits of all fetal interventions - considering whether the

148 potential benefits may or may not be achieved with alternate or delayed therapeutic approaches.

149 The risks of exposure of HCPs to COVID-19 and the availability of local resources must be

150 considered in such decisions. During the COVID-19 pandemic, fetal interventions should not

151 simply be defined as “elective” procedures.

152

153
154 * Evidence-based guidance for the provision of antenatal care, prenatal diagnosis, fetal therapy,

155 intra- and post-partum care, as well as the optimal approach to the surgical patient in the setting

156 of COVID-19 is rapidly evolving. Recommendations must be adapted in light of local COVID-

157 19 infection prevalence and resource availability. NAFTNet recommends ongoing consultation

158 with reputable organizations and institutions, such as: CDC, ACOG, ISUOG, AIUM, SOGC,

159 IFMSS, ISPD and SMFM for up-to-date information regarding specific pregnancy care in the

160 setting of COVID-19. Operating room policies and procedures should follow local guidelines as

161 well as those developed from surgical and anesthetic societies, including ACS, AORN, SOAP,

162 CAPS, and SAGES.

163

164 Legend: CDC = Centers for Disease Control & Prevention, ACOG = American College of

165 Obstetricians & Gynecologists, ISUOG = International Society for Ultrasound in Obstetrics &

166 Gynecology, AIUM = American Institute of Ultrasound in Medicine, SOGC = Society of

167 Obstetricians & Gynaecologists of Canada, ISPD = International Society for Prenatal Diagnosis,

168 IFMSS = International Fetal Medicine & Surgery Society, SMFM = Society for Maternal-Fetal

169 Medicine, ACS = American College of Surgeons, AORN = Association of Operating Room

170 Nurses, SOAP = Society for Obstetric Anesthesia & Perinatology, CAPS = Canadian

171 Association of Paediatric Surgeons, SAGES = Society of American Gastrointestinal &

172 Endoscopic Surgeons.

173

174

175

176
177 References:

178 1. DEPREST J, VANRANST M, LANNOO L, et al. SAR-CoV2 (COVID-19): Is fetal surgery in

179 times of national disasters reasonable? Prenat Diagn 2020;(in press).10.1002/PD.5702

180 2. BOELIG R, SACCONE G, BELLUSSI F, BERGHELLA V. MFM Guidance for COVID-19. Am

181 J Obstet Gynecol 2020.https://doi.org/10.1016/ j.ajogmf.2020.100106.

182 3. HOLLANDER J, CARR B. Virtually Perfect? Telemedicine for Covid-19. N Engl J Med

183 202.DOI: 10.1056/NEJMp2003539

184 4. SMFM. Joint Statement on Elective Surgeries. 2020.

185 https://s3.amazonaws.com/cdn.smfm.org/media/2266/Joint_Statement_on_Elective_Surg

186 eries_031620.pdf

187 5. SOAP. Interim Considerations for Obstetric Anesthesia Care related to COVID19. 2020.

188 https://soap.org/wpcontent/uploads/2020/03/SOAP_COVID19_Obstetric_Anesthesia_Ca

189 re_032320.pdf

190 6. ISUOG. ISUOG Safety Committee Position Statement on use of personal protective

191 equipment and hazard mitigation in relation to SARS-CoV-2 for practitioners

192 undertaking obstetric and gynecological ultrasound. 2020.

193 https://www.isuog.org/resource/isuog-safety-committee-position-statement-on-use-of-

194 personal-protective-equipment-and-hazard-mitigation-in-relation-to-sars-cov-2-for-

195 practitioners-undertaking-obstetric-and-gynecological-ultrasound.html

196
 Table 1: COVID-19 pregnancy registries

Patient
Registry Website Inclusion criteria / Objectives
recruitment
Pregnant or recently pregnant
women, either under investigation
PRIORITY https://priority.ucsf.edu/ USA only
for, or with confirmed COVID-19
infection
Any pregnant patient suspected of
COVI-Preg https://www.covi-preg.ch International
SARS-CoV-2 infection
Any woman in pregnancy or
postnatal period and/or their
PAN COVID https://pan-covid.org International
neonate with suspected or
confirmed COVID-19 infection
USA All women with COVID-19
https://mfmunetwork.bsc.gwu.e
infection in pregnancy or within 6
MFMU du/PublicBSC/MFMU/MFMUP
MFMU sites wks post-partum, at any MFMU
ublic/research-projects/
only hospital site.
Australia,
https://www.covid19chopan.hea All women with COVID19 in
New Zealand
CHOPAN lth pregnancy. Neonatal outcomes to 1
& Pacific
month of age
region
Incidence of hospitalization with
https://www.npeu.ox.ac.uk/ukos
Covid-19 infection in pregnancy -
UKOSS s/current-surveillance/covid-19- UK only
assessing maternal & infant
in-pregnancy
outcomes
All pregnant women and newborns
https://www.ucc.ie/en/npec/roic
ROI COVID-19 Ireland only <29 days of age who have been
ovid-19study/
tested for COVID-19
https://www.nvog.nl/actueel/reg
Netherlands Pregnant women with proven
NethOSS istratie-van-covid-19-positieve-
only COVID-19 infection
zwangeren-in-nethoss/