Perinatal Outcomes at Birth in Women Infected and Non-Infected with SARS-CoV-2: A Retrospective Study

Ci a ion: Vila-Candel, R.;
Ma in-A ibas, A.; Cas o-Sánchez,
E.; Escu ie , R.; Ma in-Mo eno, J.M.
Pe ina al Ou comes a Bi h in
Women In ec ed and Non-In ec ed
wi h SARS-CoV-2: A Re ospec i e
S udy. Heal hca e 2023,11, 2833.
h ps://doi.o g/10.3390/
heal hca e11212833
Academic Edi o s: Abdel-La i
Mohamed and Giuseppe Rizzo
Recei ed: 1 Sep embe 2023
Re ised: 24 Oc obe 2023
Accep ed: 25 Oc obe 2023
Published: 27 Oc obe 2023
Copy igh : © 2023 by he au ho s.
Licensee MDPI, Basel, Swi ze land.
This a icle is an open access a icle
dis ibu ed unde he e ms and
condi ions o he C ea i e Commons
A ibu ion (CC BY) license (h ps://
c ea i ecommons.o g/licenses/by/
4.0/).
heal hca e
A icle
Pe ina al Ou comes a Bi h in Women In ec ed and
Non-In ec ed wi h SARS-CoV-2: A Re ospec i e S udy
Ra ael Vila-Candel 1,2,3 , Anna Ma in-A ibas 4,* , En ique Cas o-Sánchez 5,6,7 , Ramón Escu ie 4,8
and Jose M. Ma in-Mo eno 9,10
1Sciences Facul y, Uni e sidad In e nacional de Valencia—VIU, 46002 Valencia, Spain;
a ael. ila@p o esso .uni e sidad iu.com
2Depa men o Obs e ics and Gynecology, Hospi al Uni e si a io de la Ribe a, 46600 Alzi a, Spain
3Founda ion o he P omo ion o Heal h and Biomedical Resea ch in he Valencian Region (FISABIO),
46020 Valencia, Spain
4Ghende s Resea ch G oup, School o Heal h Sciences Blanque na, Uni e si a Ramon Lull,
08025 Ba celona, Spain; [email p o ec ed]
5College o Business, A s, and Social Sciences, B unel Uni e si y London, Uxb idge UB8 3PH, UK;
en ique.cas o-sanchez@b unel.ac.uk
6Heal h P o ec ion Resea ch Uni , Heal hca e-Associa ed In ec ions and An imic obial Resis ance,
Impe ial College London, London SW7 2BX, UK
7Resea ch G oup on Global Heal h and Human De elopmen , Uni e si y o he Balea ic Islands,
07122 Palma de Mallo ca, Spain
8Ca alan Heal h Se ice, Go e nmen o Ba celona, 08014 Ba celona, Spain
9Depa men o P e en i e Medicine and Public Heal h, Uni e si a de València, 46010 Valencia, Spain
10 Biomedical Resea ch Ins i u e INCLIVA, Clinic Uni e si y Hospi al, 46010 Valencia, Spain
*Co espondence: [email p o ec ed]
Abs ac :
Backg ound: Co ona i us disease 2019 (COVID-19) was decla ed as a pandemic and public
heal h eme gency on 11 Ma ch 2020 by he Wo ld Heal h O ganiza ion. Di e en clinical ials on
he e icacy o mRNA accina ion ha e excluded p egnan women, leading o a lack o empi ical
e idence on he e icacy o he accine in his popula ion. The aim o he s udy was o examine
he associa ion be ween se e e acu e espi a o y synd ome co ona i us 2 (SARS-CoV-2) in ec ion a
bi h and ad e se pe ina al ou comes in in ec ed and non-in ec ed women om a uni e si y hospi al
in Spain. Me hods: The da a we e ob ained om elec onic heal h eco ds om 1 Ma ch 2020 o
28 Feb ua y 2022. A bi a ia e desc ip i e analysis was pe o med, compa ing women wi h and
wi hou con i med SARS-CoV-2 in ec ion du ing p egnancy using he chi-squa e es . A mul i a ia e
logis ic eg ession was complemen a ily conduc ed o de e mine whe he SARS-CoV-2 in ec ion
inc eases he isk o ad e se obs e ic and pe ina al ou comes. Resul s: A o al o 2676 women we e
di ided in o wo g oups: non-in ec ed wi h SARS-CoV-2 (n= 2624) and in ec ed wi h SARS-CoV-2
(n= 52). In ec ed women we e p ima ily mul ipa ous (p< 0.03) and had ecei ed an incomple e
accina ion egimen (p< 0.001). A g ea e incidence o p ema u e up u e o memb anes (p< 0.04)
was obse ed among he non-in ec ed women. Pe aining o pe ina al ou comes, he e was a no able
ise in NICU admissions (p< 0.014), coupled wi h an ex ended du a ion o s ay (p< 0.04), o neona es
bo n o in ec ed mo he s in compa ison o hei non-in ec ed coun e pa s. Conclusion: Al hough
SARS-CoV-2 in ec ion may pose signi ican isks o p egnan women and hei in an s, ad e se
obs e ical/pue pe al ou comes do no signi ican ly di e be ween women in ec ed and non-in ec ed
o SARS-CoV-2 in ou s udy. NICU admissions we e highe o neona es bo n o in ec ed mo he s.
Addi ionally, co ona i us disease 2019 accina ion du ing p egnancy is no associa ed wi h se e e
ad e se pe ina al ou comes.
Keywo ds: SARS-CoV-2; accina ion; women’s heal h; pe ina al ou comes; ad e se ou comes
Heal hca e 2023,11, 2833. h ps://doi.o g/10.3390/heal hca e11212833 h ps://www.mdpi.com/jou nal/heal hca e
Heal hca e 2023,11, 2833 2 o 18
1. In oduc ion
Co ona i us disease 2019 (COVID-19) was decla ed as a pandemic and public heal h
eme gency on 11 Ma ch 2020 by he Wo ld Heal h O ganiza ion. Since he i s de ec ed
case o COVID-19 in Wuhan, Hubei, China, in Decembe 2019, he in ec ion sp ead o he
es o he wo ld wi h an ala ming numbe o cases [1,2].
The ini ial ansmission pa e n has been sugges ed o be zoono ic, while he cu en
sp ead has been om pe son o pe son h ough ai bo ne ansmission ollowing close
con ac wi h an in ec ed pe son o di ec con ac wi h con amina ed su aces [
3
,
4
]. The
isk o e ical ansmission appea s o be low (app oxima ely 0–4%) and, he e o e, o
modes ele ance [
5
–
7
]. Se e e acu e espi a o y synd ome co ona i us 2 (SARS-CoV-2)
may be de ec ed in amnio ic luid, bu his is excep ional. Al hough SARS-CoV-2 has been
isola ed in he placen a, e ical ansmission o he i us appea s o be a e and limi ed
o cases o se e e ma e nal in ec ion [
8
]. Mos desc ibed cases o in ec ion in newbo ns
a e om ho izon al ansmission. In addi ion, he i us has no been de ec ed in aginal
sec e ions o b eas milk [
8
–
10
]. The a ailable da a sugges a ange o i al RNA p esence
in milk samples, spanning om 2% o 6%. A ecen sys ema ic e iew [
11
] o lac a ing
indi iduals a ec ed by COVID-19 e ealed a 13.2% de ec ion a e o SARS-CoV-2 RNA.
Simila ly, ano he sys ema ic e iew [
12
] indica ed a ound a 2% de ec ion a e o RNA
in b eas milk. Among hese s udies, he mos ex ensi e in ol ed 110 women om he
US [
13
], 65 o whom es ed posi i e o SARS-CoV-2. In his s udy, 6% o he milk samples
exhibi ed SARS-CoV-2 RNA p esence; howe e , no in ec ious pa icles we e cul u ed om
hese samples. No ably, a ecen clinical ial yielded di e en esul s, as no SARS-CoV-2
RNA was de ec ed in any o he b eas milk samples [
14
]. The indings o his ial endo se
o icial ecommenda ions ha unde line he sa e y o b eas eeding du ing COVID-19.
This pe spec i e p io i izes b eas eeding due o i s po en ial o con e ma e nal–neona al
bene i s.
COVID-19 may be asymp oma ic in up o 75% o p egnan women [
15
]. When symp-
oms appea , he in ec ion is classi ied acco ding o he se e i y o espi a o y symp oms
as mild, mode a e, and se e e [
4
]. The majo i y o symp oma ic cases du ing ges a ion
p esen a mild in ec ion (85%) [
16
]. The mos equen symp oms du ing p egnancy a e
e e (40%) and cough (39%), while o he less equen symp oms a e myalgia, dyspnea,
odynophagia, anosmia, expec o a ion, headache, and dia hea [5].
P egnan women a e a a highe isk o se e e in ec ion- ela ed complica ions wi h
espec o he non-p egnan popula ion, especially in he hi d imes e and when he
ollowing isk ac o s a e p esen : ad anced ma e nal age, high body mass index (BMI o
>30 kg/m
2
), ch onic hype ension, and/o p eges a ional diabe es [
17
]. App oxima ely 15%
o COVID-19 cases p og ess o se e e o ms [
18
]. App oxima ely 5% o in ec ed p egnan
women may equi e admission o an in ensi e ca e uni (ICU), and 3% may equi e in asi e
en ila ion [
7
]. The a e o mo ali y in p egnan women anges om 0.1% o 1.2%. Se e e
o ms p esen he ollowing main complica ions: se e e pneumonia, acu e espi a o y
dis ess synd ome, h omboembolic disease, bac e ial espi a o y supe in ec ion, ca diac
al e a ions, encephali is, sepsis, and sep ic shock [6,7,19].
Rega ding e al o neona al complica ions, he cu en da a do no sugges an inc eased
isk o misca iage o ea ly ges a ional loss in p egnan women wi h COVID-19 [
7
]. Simi-
la ly, se e e acu e espi a o y synd ome co ona i us and Middle Eas espi a o y synd ome
co ona i us ha e no been epo ed o demons a e a clea causal ela ionship wi h hese
complica ions [
20
]. No inc eased isk o congeni al de ec s has also been desc ibed [
9
].
The main pe ina al complica ion associa ed wi h COVID-19 is p ema u i y, wi h a es
a ound 20%, mainly a he expense o ia ogenic p ema u i y [
5
,
7
]. The e may be placen al
in ol emen and ana omopa hological al e a ions in he o m o ascula malpe usion
o in e illous ib in deposi s whose consequences a he e al le el ha e ye o be de e -
mined [
5
]. No signi ican di e ences in o he pe ina al ou comes ha e been ound among
neona es bo n o mo he s wi h COVID-19, al hough 25% a e admi ed o a neona al ca e
Heal hca e 2023,11, 2833 3 o 18
uni [
8
]. Rega ding neona al COVID-19, 50% o cases gene ally p esen o adul clinics wi h
compa able esul s in e ms o symp oma ology and analy ical and imaging indings [7].
Be ween 2020 and 2022, Spain expe ienced six pandemic wa es o COVID-19, each
p esen ing dis inc challenges. Th oughou his pe iod, s ingen measu es we e en o ced
du ing s a es o eme gency o cu b i al ansmission [
21
]. These measu es had di ec
epe cussions on he medical ca e p o ided o p egnan women, esul ing in disce nible
adjus men s o obs e ic p o ocols [
22
,
23
]. Scien i ic socie ies emained dynamic, con inually
adap ing obs e ic ca e p o ocols in esponse o e ol ing epidemiological ends [
5
]. The
in ica e in e play be ween COVID-19 p e en ion and ensu ing sa e ca e o mo he s and
newbo ns assumed pa amoun impo ance.
Howe e , ac oss hese successi e pandemic wa es, ce ain indispensable p ac ices in
ma e nal and childbi h ca e unde wen necessa y adap a ion o suspension o mi iga e
i us sp ead. As he landscape e ol ed, p ac ices like labo companionship, ea ly skin-
o-skin con ac , and ooming-in we e supplan ed by measu es such as mo he –in an
sepa a ion and neona al in ensi e ca e uni (NICU) admission [
23
]. While hese adjus men s
aimed o sa egua d bo h mo he s and medical pe sonnel, conce ns abou ca e quali y
ine i ably a ose.
The modi ica ion o hese p ac ices bo e nega i e implica ions o he ma e nal expe i-
ence and neona al heal h, hampe ing mo he –in an in e ac ion and impeding b eas eeding
p omo ion [24]. As he pandemic p og essed, heal hca e p o essionals pe se e ed in hei
e o s o s ike a delica e balance be ween p e en i e measu es and main aining a wa m,
secu e en i onmen du ing he bi hing p ocess. This unde sco ed he u gency o emb ac-
ing adap able, e idence-based app oaches o sa egua d ma e nal and neona al heal h amid
heal h c ises and epidemiological luc ua ions [22].
In 2021, he accina ion campaign i s expanded o encompass adul s, and subse-
quen ly, commencing Decembe o ha yea , ex ended o include p egnan women [
25
].
Robus s udies unequi ocally endo sed he sa e y and e icacy o accines, d i ing a g ad-
ual accep ance and a o able esponse wi hin he populace [
6
,
9
,
26
]. This mul i ace ed
in e play be ween pandemic wa es, e ol ing p o ocols, and accina ion e o s unde -
sco es he need o dynamic, e idence-d i en s a egies o ensu e op imal ca e p o ision
du ing imes o c isis.
Al hough a published se ies o accina ions du ing p egnancy s ill include ew cases,
he cu en ly a ailable COVID-19 accines a e no expec ed o pose a p oblem du ing
p egnancy and lac a ion [
6
,
9
,
26
,
27
]. The ecen ecommenda ion is o o e a messenge
RNA (mRNA) accine o all p egnan women ollowing es ablished accina ion schedules
and especially o p egnan women wi h como bidi ies (e.g., pa ien s who unde wen ans-
plan a ion, who a e immunosupp essed, o who ha e ca diopulmona y, enal, oncologic, o
o he condi ions) [
28
]. The ideal ime o adminis a ion is he second imes e . Howe e ,
i he epidemiological isk is high o he e a e como bidi ies, he e is no incon enience in
adminis e ing he accine in he i s imes e [29].
Di e en clinical ials on he e icacy o mRNA accina ion ha e excluded p egnan
women, leading o a lack o empi ical e idence on he e icacy o he accine in his
popula ion [
26
,
30
]. The e o e, accine sa e y and e icacy du ing p egnancy a e mainly
e alua ed h ough obse a ional epidemiological s udies [31].
In his s udy, a he beginning o he pandemic, whe e accina ion e o s we e nascen
and he ci cula ing i us eached conside ably highe le els wi hin he communi y, ou
aim was o explo e he associa ion be ween SARS-CoV-2 in ec ion a bi h and ad e se
obs e ical–neona al ou comes om a uni e si y hospi al in Spain.
In addi ion, we assessed he p opo ion o neona es wi h e e se ansc ip ion poly-
me ase chain eac ion (RT-PCR)-de ec able SARS-CoV-2 om all bi hs among women wi h
COVID-19 diagnosed a he onse o labo .
Heal hca e 2023,11, 2833 4 o 18
2. Ma e ials and Me hods
This obse a ional, e ospec i e s udy (clinical/epidemiological, desc ip i e, and
analy ical in na u e) was conduc ed among p egnan women who isi ed he Hospi al
Uni e si a io de la Ribe a (HULR) o deli e y om 1 Ma ch 2020 o 28 Feb ua y 2022.
The HULR is a egional hospi al wi h a popula ion a ea o 250,000 inhabi an s and
assis s an a e age o 1300 deli e ies pe yea . Deli e ies o less han 34 weeks o ges a ion
a e e e ed o a e e al hospi al.
The women we e alloca ed in o in ec ed and non-in ec ed g oups based on he esul s
o RT-PCR o an igen es ing (nasopha yngeal exuda e) o SARS-CoV-2 a hospi al admis-
sion. The in ec ed g oup included women posi i e o SARS-CoV-2 on RT-PCR o an igen
es ing du ing deli e y, and non-in ec ed g oup included women wi h a nega i e esul .
In o ma ion on COVID-19 accina ion was collec ed om bo h un accina ed and
accina ed women. Women who ecei ed a leas one dose o he COVID-19 accine ei he
be o e o du ing he cu en p egnancy we e included in he accina ed coho . Al hough
his g oup was labeled as “ accina ed”, some women did no ollow he ull accina ion
schedule a he ime o deli e y.
P egnan women in ec ed wi h SARS-CoV-2 admi ed o medical/su gical easons
o he han childbi h we e excluded.
2.1. Sample Size
F om 1 Ma ch 2020 o 28 Feb ua y 2022, he en i e popula ion whose deli e ies we e
a ended du ing he s udy pe iod was conside ed. In he i s yea (1 Ma ch 2020, o
28 Feb ua y 2021
), he e we e 1236 deli e ies. Simila ly, in he second yea (1 Ma ch 2021,
o 28 Feb ua y 2022), he e we e 1440 deli e ies.
2.2. Da a Collec ion
The in o ma ion necessa y o inclusion in he s udy was ob ained om wo di e en
sou ces: (1) elec onic medical eco ds o specialized ca e, om which a iables ela ed o
ca e du ing childbi h and pue pe ium and subsequen complica ions we e collec ed, and
(2) p ima y ca e medical eco ds, om which he accina ion s a us.
The obs e ical ou comes e alua ed we e as ollows: p ema u e up u e o memb anes
(PROM), p e e m bi h (<37 weeks o ges a ion), placen al ab up ion, an epa um hem-
o hage, pos pa um hemo hage, cesa ean sec ion, ins umen al deli e y, e al dis ess
(de ined by a heal hca e p o ide ), e al g ow h es ic ion (es ima ed e al weigh below
he hi d pe cen ile), p egnancy-induced hype ension, and ges a ional diabe es.
The COVID-19- ela ed ou comes we e p esen ing signs/symp oms, admission o an
in ensi e ca e uni (ICU), leng h o ICU s ay o mo e han 4 days, in uba ion, supplemen al
oxygen, ca diac mani es a ions (myoca dial in a c ion, ca diomyopa hy, o a hy hmia),
neu ologic mani es a ions (seizu es, hemo hagic o ischemic s oke, o coma), h om-
bo ic mani es a ions (deep ein h ombosis, pulmona y embolism, o a e ial h ombosis),
coagulopa hy, and ma e nal dea h du ing admission.
The neona al ou comes we e small o ges a ional age (SGE: bi hweigh below he 10 h
pe cen ile), la ge o ges a ional age (LGE: bi hweigh abo e he 90 h pe cen ile), Apga
sco e o <7 a 5 min, neona al in ensi e ca e uni (NICU) admission, leng h o neona al ICU
s ay o mo e han 4 days, espi a o y dis ess, en ila o suppo , SARS-CoV-2 in ec ion,
hypoxic ischemic encephalopa hy, and neona al dea h.
O he co a ia es included sociodemog aphic and medical cha ac e is ics ha could
ac as po en ial isk ac o s: ma e nal age, pa i y, ges a ional age a bi h, da e o bi h,
coun y o o igin, ges a ional pa hologies ( hy oid, ges a ional diabe es and p eeclampsia),
o he clinical a iables (ma e nal obesi y, as hma, o smoke ), mRNA SARS-CoV-2 accine
(P ize -BioNTech), numbe o doses, and ime be ween las accine adminis a ion and
in ec ion (when in ec ed) (Figu e 1).
Heal hca e 2023,11, 2833 5 o 18
Heal hca e2023,11,xFORPEERREVIEW5o 18



Figu e1. Da acollec ion lowcha .
2.3.S a is icalAnalysis
We i s pe o medauni a ia edesc ip i eanalysiso  hebi hcha ac e is ics.Quan-
i a i e a iableswe esumma izedasmeansands anda dde ia ionsandca ego ical a -
iablesasabsolu eand ela i e equencies.
Subsequen ly,abi a ia edesc ip i eanalysiswasconduc ed,compa ing hein ec ed
andnon-in ec edg oups.Ca ego ical a iableswe ecompa edusing heChi-squa e es 
andquan i a i e a iablesusingANOVA.Thecompu a iono odds a iosand hei co -
espondingcon idencein e als,accompaniedbyp- aluesde i ed omlog-odds
h ough heu iliza iono  heWald es ,wasexecu edbyemployingase ieso logis ic
eg essionmodels ea u ingasoleindependen  a iable[32].In hein es iga ionpe ain-
ing odis inc  accina ions a uses(un accina ed,incomple e egimen,comple e egi-
men),ananalogousme hodologywasapplied.Howe e ,in hisins ance,amul inomial
eg ession amewo kwi halogi link unc ionwasemployed.Finally,amul i a ia e
Figu e 1. Da a collec ion lowcha .
2.3. S a is ical Analysis
We i s pe o med a uni a ia e desc ip i e analysis o he bi h cha ac e is ics. Quan-
i a i e a iables we e summa ized as means and s anda d de ia ions and ca ego ical
a iables as absolu e and ela i e equencies.
Subsequen ly, a bi a ia e desc ip i e analysis was conduc ed, compa ing he in ec ed
and non-in ec ed g oups. Ca ego ical a iables we e compa ed using he Chi-squa e es
and quan i a i e a iables using ANOVA. The compu a ion o odds a ios and hei co e-
sponding con idence in e als, accompanied by p- alues de i ed om log-odds h ough
he u iliza ion o he Wald es , was execu ed by employing a se ies o logis ic eg es-
sion models ea u ing a sole independen a iable [
32
]. In he in es iga ion pe aining o
dis inc accina ion s a uses (un accina ed, incomple e egimen, comple e egimen), an

Heal hca e 2023,11, 2833 6 o 18
analogous me hodology was applied. Howe e , in his ins ance, a mul inomial eg es-
sion amewo k wi h a logi link unc ion was employed. Finally, a mul i a ia e logis ic
eg ession analysis using he backwa d Wald me hod was pe o med o de e mine whe he
SARS-CoV-2 in ec ion inc eases he isk o ad e se obs e ic and pe ina al ou comes. The
signi icance o SARS-CoV-2 in ec ion o each ou come a iable and ORs we e e alua ed.
S a is ical signi icance was se a a p- alue o
≤
0.05. Da a we e s a is ically analyzed using
R ( e sion 4.0.2).
2.4. E hics S a emen
Nei he in o med consen no a pa ien in o ma ion shee was equi ed owing o he
e ospec i e na u e o he s udy. Only elec onic medical eco ds we e e iewed, and no
con ac was made a any ime wi h he pa ien s whose da a we e analyzed. No iden i ying
da a o he women and/o hei newbo ns we e included in he da a collec ion no ebook.
The s udy complied wi h he Helsinki Recommenda ions o biomedical s udies and was
app o ed by he Resea ch and E hics Commi ee o he HULR (HULR_2022_56).
3. Resul s
3.1. Desc ip i e Analysis
We ob ained a o al sample o 2676 women and di ided hem in o wo g oups: in ec ed
wi h SARS-CoV-2 (n= 52) and unin ec ed wi h SARS-CoV-2 (n= 2624).
The mean ma e nal age was 31.2
±
6.1 yea s; o he women, 55.5% we e nullipa ous
(
n= 1484
), and 71.8% we e bo n in Spain (n= 1922). SARS-CoV-2 posi i i y was de e mined
ia RT-PCR (n= 50) and an igen es ing (n= 2). The incidence o SARS-CoV-2 in ec ion was
14.6 pe 1000 bi hs (18/1236) in 2020 and 23.6 pe 1000 bi hs (34/1440) in 2021. A o al
o 20.5% o he sample was accina ed (n= 550): 16.5% wi h a comple e P ize egimen
(n= 442) and 4.0% wi h a leas one dose (n= 108). The median numbe o days om
he las accine adminis a ion o in ec ion was 102.5 days wi h an in e qua ile ange o
72.75 days.
F om he beginning o 2021, SARS-CoV-2 su eillance in Spain included genomic
in o ma ion assessmen o con i ma ion o he p esence o a ian s using sequencing
echniques. The in o ma ion a ailable in he su eillance sys em in Spain (SiViEs) is
analyzed on a weekly basis. This s udy collec ed all cases eco ded du ing he i s i e
wa es in Spain. Acco ding o he SiViEs da a, he i s h ee wa es ( om Ma ch 2020 o
Janua y 2021) we e caused by he alpha a ian , he ou h wa e ( om July o Sep embe
2021) by he del a a ian , and he i h wa e ( om Janua y 2022) by he omic on a ian .
Thus, he dis ibu ion o cases acco ding o he es ima ion o SARS-CoV-2 a ian s
was as ollows: alpha, 38.5% (20/52); del a, 7.7% (4/52); and omic on, 53.8% (28/52).
3.2. Bi a ia e Analysis
Table 1shows he esul s o he bi a ia e analysis be ween he in ec ed and non-
in ec ed g oups. In o al, 1.9% o he sample (n= 52) was posi i e o SARS-CoV-2. We
obse ed ha he isk o in ec ion o un accina ed women was ou imes lowe compa ed
o accina ed women (OR: 4.0 (95% CI: 2.3–6.9; p< 0.001). In con as , when g ouping
he sample in women accina ed wi h a comple e egimen ( wo doses) and incomple e
egimen (one dose), he isk es ima e sugges s ha women wi h incomple e accina ion
had i e- old isk compa ed wi h hose accina ed wi h he comple e dose (OR: 5.6, 95% CI:
2.2–13.0; p< 0.001). Mul ipa ous women we e signi ican ly mo e in ec ed han nullipa ous
women (OR: 1.9 95% CI: 1.1–3.3; p= 0.03).
Heal hca e 2023,11, 2833 7 o 18
Table 1.
Compa ison o he accina ion s a us and sociodemog aphic cha ac e is ics be ween he
women non-in ec ed and in ec ed o SARS-CoV-2 (N = 2676).
SARS-CoV-2 In ec ion
To al No Yes
OR 195% CI 1p-Value *,‡
N = 2676 n= 2624 (98.1%) n= 52 (1.9%)
Ma e nal age 1.00 1.0, 1.0 0.911
Mean (SD) 31.19 (6.12) 31.19 (6.11) 31.29 (6.58)
Median (IQR) 32.00 (27.00, 36.00) 32.00 (27.00, 36.00) 31.50 (27.00, 35.25)
Range 14.00, 50.00 14.00, 50.00 18.00, 46.00
Pa i y
P imipa ous 1484 (55.5%) 1463 (55.8%) 21 (40.4%) 1.00 —
Mul ipa ous 1192 (44.5%) 1161 (44.2%) 31 (59.6%) 1.91 1.1, 3.3 0.03
Coun y o o igin
Spain 1922 (72%) 1886 (72%) 36 (69%) 1.00 —
Fo eign 754 (28%) 738 (28%) 16 (31%) 1.13 0.6, 2.0 0.675
Vaccina ion s a us
No 2126 (79.5%) 2100 (80%) 26 (50%) 1.00 —
Yes 550 (20.5%) 524 (20%) 26 (50%) 4.04 2.3, 6.9 <0.001
Dose
Un accina ed 2126 (79%) 2100 (80%) 26 (50%) 1.00 —
Incomple e
egimen 108 (4.0%) 101 (3.8%) 7 (13%) 5.63 2.2, 13.0 <0.001
Comple e egimen 442 (17%) 423 (16%) 19 (37%) 3.64 2.0, 6.6 <0.001
1OR = odds a io, CI = con idence in e al; * Chi-squa ed es ; ‡S uden - es .
The sociodemog aphic a iables did no signi ican ly di e be ween he g oups.
Table 2shows he compa ison o he obs e ic a iables and hei exposu e o SARS-
CoV-2. The da a indica e ha in ec ed women had a lowe isk o de eloping PROM
compa ed wi h non-in ec ed women (OR: 0.4 95% CI: 0.2–0.7; p= 0.004). Only 7.7% (4/52)
o he women posi i e o SARS-CoV-2 p esen ed minimal symp oms and, he e o e, no
an epa um o pos pa um complica ions. The cesa ean sec ion a e was 19.7% (527/2676)
among he o al popula ion, 15.4% (8/52) among he in ec ed g oup, and 19.8% (519/2624)
among he non-in ec ed g oup; no signi ican di e ences we e ound be ween he g oups.
No cases we e obse ed o e al g ow h es ic ion, placen al ab up ion, ma e nal dea h, ma-
e nal in uba ion, and ca diac, neu ological, h ombo ic, and coagulopa hy mani es a ions.
We obse ed ha in ec ed women we e admi ed o ICU o mo e days (p< 0.001).
On he o he hand, we analyzed he di e ences among a ious ma e nal como bidi ies,
such as ma e nal obesi y (BMI > 30 kg/m
2
), as hma, hype hy oidism, hypo hy oidism,
and smoking, and did no obse e s a is ically signi ican di e ences be ween in ec ed and
non-in ec ed women.
The ou comes and complica ions in he newbo ns bo n o mo he s wi h COVID-19
did no also signi ican ly di e be ween he g oups (Table 3). No cases o neona al dea h,
neona al anemia, neona al sepsis, neona al SARS-CoV-2 in ec ion, Apga < 7 a 5 min,
and hypoxic ischemic encephalopa hy we e obse ed in in ec ed women. Newbo ns bo n
o in ec ed mo he s did ha e a highe likelihood o NICU admission compa ed o hose
bo n o unin ec ed mo he s
(p= 0.014)
and a leng h o s ay a NICU mo e han ou days
(p= 0.004).
Heal hca e 2023,11, 2833 8 o 18
Table 2.
Compa ison o he obs e ic cha ac e is ics be ween he non-in ec ed and in ec ed women
wi h SARS-CoV-2 (N = 2676).
SARS-CoV-2 In ec ion
To al No Yes
OR 195% CI 1p-Value *,‡
N = 2676 (100%) n= 2624 (98.1%) n= 52 (1.9%)
P e e m bi h < 37 weeks
No 2466 (92) 2419 (92.2) 47 (90.4) 1.00 —
Yes 210 (7.8) 205 (7.8%) 5 (9.6%) 1.29 0.4, 2.9 0.633
P ema u e up u e o memb anes
No 1564 (58) 1523 (58) 41 (79) 1.00 —
Yes 1112 (42) 1101 (42) 11 (21) 0.41 0.2, 0.7 0.004
An epa um hemo hage
No 2651 (99) 2600 (99.1) 51 (98.1) 1.0 —
Yes 25 (0.9) 24 (0.9) 1 (1.9) 2.12 0.1, 10 0.465
Pos pa um hemo hage
No 2655 (99.2) 2604 (99.2) 51 (98.1) 1.00 —
Yes 21 (0.8) 20 (0.8) 1 (1.9) 2.64 0.1, 13 0.365
Caesa ean sec ion
No 2149 (79.3) 2105 (80.2) 44 (84.6) 1.00 —
Yes 527 (19.7) 519 (19.8) 8 (15.4) 0.72 0.3, 1.5 0.432
Ins umen al deli e y
No 2358 (88) 2316 (88) 42 (81) 1.00 —
Yes 318 (12) 308 (12) 10 (19) 1.81 0.8, 3.5 0.103
Fe al dis ess
No 2642 (99) 2592 (98.8) 50 (96.2) 1.00 —
Yes 34 (1.3) 32 (1.2) 2 (3.8) 3.23 0.5, 11 0.113
P eeclampsia/eclampsia/ges a ional
hype ension/HELLP
No 2595 (97) 2544 (97) 51 (98.1) 1.00 —
Yes 81 (3.0) 80 (3.0) 1 (1.9) 0.61 0.0, 2.9 0.642
Ges a ional diabe es
No 2479 (93) 2431 (92.6) 48 (92.3) 1.00 —
Yes 197 (7.4) 193 (7.4) 4 (7.7) 1.00 0.3, 2.6 0.927
P esence o SARS-CoV-2
signs/symp oms
No 2672 (99.9) 2624 (100) 48 (92.3)
Yes 4 (0.1) 0 (0) 4 (7.7)
ICU admission
No 2661 (99.4) 2610 (99.5) 51 (98.1) 1.00 —
Yes 15 (0.6) 14 (0.5) 1 (1.9) 3.72 0.2, 19 0.215
Days in ICU
Mean (SD) 1.33 (0.90) 1.14 (0.53) 4.00 (NA)
Median (IQR) 1.00 (1.00, 1.50) 1.00 (1.00, 1.00) 4.00 (4.00,
4.00)
Range 0.00, 4.00 0.00, 2.00 4.00, 4.00
Supplemen al oxygen
No 2669 (100%) 2618 (99.8%) 51 (98.1%) 1.00 —
Yes 7 (0.3%) 6 (0.2%) 1 (1.9%) 8.61 0.4, 51 0.049
As hma
No 2644 (98.8) 2594 (98.9) 50 (96,2) 1.00 —
Yes 32 (1.2) 30 (1.1) 2 (3.8) 1.19 0.8, 1.7 0.075
Heal hca e 2023,11, 2833 9 o 18
Table 2. Con .
SARS-CoV-2 In ec ion
To al No Yes
OR 195% CI 1p-Value *,‡
N = 2676 (100%) n= 2624 (98.1%) n= 52 (1.9%)
BMI > 30 kg/m2
No 2418 (90.4) 2370 (90.3) 47 (90.4) 1.00 —
Yes 259 (9.6) 254 (9.7) 5 (9.6) 1.21 0.8, 1.3 0.987
Hype hy oidism
No 2632 (98.4) 2581 (98.4) 51 (98.1) 1.00 —
Yes 44 (1.6) 43 (1.6) 1 (1.9) 0.17 0.3, 0.6 0.875
Hypo hy oidism
No 2249 (84.0) 2205 (84.0) 44 (84.6) 1.00 —
Yes 427 (26.0) 419 (26.0) 8 (5.4) 0.10 0, 0.3 0.909
Smoke
No 2479 (92.6) 2431 (92.6) 48 (92.3) 1.00 —
Yes 197 (7.4) 193 (7.4) 4 (7.7) 1.09 0.7, 1.3 0.876
1
OR = odds a io, CI = con idence in e al; * Chi-squa ed es ;
‡
S uden - es ; PROM: p ema u e up u e o
memb anes; ICU: in ensi e ca e uni ; BMI: body mass index.
Table 3.
Compa ison o neona al cha ac e is ics be ween non-in ec ed and in ec ed mo he s’ new-
bo ns o SARS-CoV-2 (N = 2676).
SARS-CoV-2 In ec ion
To al No Yes
OR 195% CI 1p-Value *,‡
N = 2676 (100%) n= 2624 (98.1%) n= 52 (1.9%)
Small o ges a ional age
No 2600 (97.2%) 2550 (97.2%) 50 (96.2%) 1.00 —
Yes 76 (2.8%) 74 (2.8%) 2 (3.8%) 1.39 0.2, 4.6 0.661
La ge o ges a ional age
No 2354 (88%) 2306 (88%) 48 (92.3%) 1.00 —
Yes 322 (12%) 318 (12%) 4 (7.7%) 0.61 0.2, 1.5 0.336
Respi a o y dis ess
No 2637 (98.5%) 2587 (98.6%) 50 (96.4%) 1.00 —
Yes 39 (1.5%) 37 (1.4%) 2 (3.8%) 2.83 0.4, 9.5 0.165
NICU admission
No 2465 (92.1%) 2422 (92.3%) 43 (83%) 1.00 —
Yes 211 (7.9%) 202 (7.7%) 9 (17%) 2.47 1.1, 5.0 0.014
Leng h o s ay >4 days
No 2647 (98.9%) 2598 (99.0%) 49 (94%) 1.00 —
Yes 29 (1.1%) 26 (1.0%) 3 (5.8%) 6.07 1.4, 18 0.004
Ven ila o suppo
No 2639 (98.6%) 2589 (98.7%) 50 (96%) 1.00 —
Yes 37 (1.4%) 35 (1.3%) 2 (3.8%) 3.00 0.5, 10 0.143
Neona al dea h
No 2670 (99.8%) 2618 (99.8%) 52 (100%) 1.00 —
Yes 6 (0.2%) 6 (0.2%) 0 (0%) 0.00 0.984
1
OR = odds a io, CI = con idence in e al; * Chi-squa ed es ;
‡
S uden - es ; NICU: neona al in ensi e ca e uni .
We also analyzed sociodemog aphic, obs e ic, and neona al ou comes among ac-
cina ed and un accina ed women (Supplemen a y Table S1). Mul ipa ous women and
women bo n ou side Spain we e accina ed less han women bo n in Spain (p< 0.001;
p= 0.016
, espec i ely), wi h no s a is ically signi ican di e ences in e ms o ma e nal age.
Heal hca e 2023,11, 2833 16 o 18
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