Ci a ion: Rod íguez-Gallego, I.;
Vila-Candel, R.; Co ales-Gu ie ez, I.;
Gomez-Baya, D.; Leon-La ios, F.
E alua ion o he Impac o a Midwi e-
Led B eas eeding G oup In e en ion
on P e en ion o Pos pa um
Dep ession: A Mul icen e Randomised
Clinical T ial. Nu ien s 2024,16, 227.
h ps://doi.o g/10.3390/nu16020227
Academic Edi o : Tamás Decsi
Recei ed: 23 Decembe 2023
Re ised: 6 Janua y 2024
Accep ed: 8 Janua y 2024
Published: 10 Janua y 2024
Copy igh : © 2024 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/).
nu ien s
A icle
E alua ion o he Impac o a Midwi e-Led B eas eeding G oup
In e en ion on P e en ion o Pos pa um Dep ession: A
Mul icen e Randomised Clinical T ial
Isabel Rod íguez-Gallego
1,2
, Ra ael Vila-Candel
3,4,5,
* , Isabel Co ales-Gu ie ez
6,7,
* , Diego Gomez-Baya
8
and Fa ima Leon-La ios 9
1
Foe al Medicine, Gene ics and Rep oduc ion Uni , Vi gen del Rocío Uni e si y Hospi al, 41009 Se ille, Spain;
is oga@c uz oja.es
2Red C oss Nu sing Uni e si y Cen e, Uni e si y o Se ille, 41013 Se ille, Spain
3Facul y o Heal h Sciences, Uni e sidad In e nacional de Valencia (VIU), 46002 Valencia, Spain
4La Ribe a P ima y Heal h Depa men , 46600 Alzi a, Spain
5Founda ion o he P omo ion o Heal h and Biomedical Resea ch in he Valencian Region (FISABIO),
46020 Valencia, Spain
6Su ge y Depa men , Facul y o Medicine, Uni e si y o Se ille, 41009 Se ille, Spain
7Foe al Medicine Uni , Vi gen Maca ena Uni e si y Hospi al, 41009 Se ille, Spain
8Depa men o Social, De elopmen al and Educa ional Psychology, Uni e sidad de Huel a,
21007 Huel a, Spain; [email p o ec ed]
9Nu sing Depa men , School o Nu sing, Physio he apy and Podia y, Uni e si y o Se ille,
41009 Se ille, Spain; [email p o ec ed]
*Co espondence: a ael. ila@p o esso .uni e sidad iu.com (R.V.-C.); [email p o ec ed] (I.C.-G.)
Abs ac : Pos pa um dep ession is a signi ican heal h issue a ec ing bo h mo he s and newbo ns
du ing he pos pa um pe iod. G oup suppo in e en ions du ing his pe iod ha e p o en e ec i e
in helping women cope wi h dep ession and imp o ing b eas eeding a es. This s udy aimed o
assess he e ec i eness o a midwi e-led b eas eeding suppo g oup in e en ion on b eas eeding
a es, pos pa um dep ession and gene al sel -e icacy. This was a mul icen ic clus e andomised
con olled ial wi h con ol and in e en ion g oups and was no blinded. I was conduc ed in
Andalusia (sou he n Spain) om Oc obe 2021 o May 2023. A o al o 382 women pa icipa ed in
he s udy. The esul s showed a signi ican di e ence in exclusi e b eas eeding a es a 4 mon hs
pos pa um be ween he g oups (con ol 50% s. in e en ion 69.9%; p< 0.001). Addi ionally,
he e was a lowe mean sco e on he Edinbu gh Pos na al Dep ession Scale in he in e en ion
g oup (
12.49 ±3.6
s. 13.39
±
4.0; p= 0.044). Simila ly, highe sco es o gene al sel -e icacy we e
obse ed among b eas eeding women a 2 and 4 mon hs pos pa um (77.73
±
14.81; p= 0.002 and
76.46 ±15.26;
p< 0.001, espec i ely). In conclusion, midwi e-led b eas eeding suppo g oups
enhanced sel -e icacy, p olonged b eas eeding and educed pos pa um dep ession 4 mon hs a e
gi ing bi h.
Keywo ds: b eas eeding; suppo g oup; lac a ion; sel -help g oup; pos pa um dep ession; gene al
sel -e icacy; women’s men al heal h
1. In oduc ion
The pos pa um pe iod en ails signi ican physical, psychosocial and social changes
o women as hey adap o a new si ua ion. The e o e, i is known as a pe iod o spe-
cial ulne abili y ela ed o ma e nal men al heal h [
1
]. App oxima ely 9.6% o 19.2%
o mo he s expe ience a majo o mino dep essi e episode du ing he i s 12 mon hs
a e childbi h [
2
]. Thus, one o he main complica ions du ing he pos pa um pe iod is
pos pa um dep ession (PPD) [3,4].
Globally, one in i e women is es ima ed o de elop PPD. Howe e , he p e alence
o PPD a ies signi ican ly be ween geog aphic a eas and cul u es. Sou he n A ica has
Nu ien s 2024,16, 227. h ps://doi.o g/10.3390/nu16020227 h ps://www.mdpi.com/jou nal/nu ien s
Nu ien s 2024,16, 227 2 o 15
he highes epo ed p e alence (39.96%), eas e n Eu ope (16.62%) and sou he n Eu ope
(16.34%) show in e media e p e alence and Oceania (11.11%) has some o he lowes
epo ed igu es [
5
–
7
]. Fu he mo e, coun ies wi h highe income and de eloped coun ies
ha e a signi ican ly lowe p e alence han lowe income o de eloping coun ies [
5
].
Howe e , hese igu es may unde es ima e he ue ex en o he p oblem due o ba ie s o
de ec ion and he s igma associa ed wi h men al illnesses in he pe ina al con ex . Some
es ima es sugges ha mo e han 50% o women wi h PPD a e no diagnosed [
6
]. PPD
gene ally occu s wi hin 4 weeks a e deli e y and can las 6 mon hs o longe a e deli e y,
al hough some au ho s indica e ha i could las up o 2 yea s a e deli e y [4,8–10].
B eas eeding p o ides mul iple demons a ed bene i s on he physical, cogni i e and
social le els o bo h he mo he and he newbo n [
11
–
13
]. Howe e , he psychological
bene i s, especially hose conce ning PPD, a e s ill la gely unknown. The e is a complex
physiological ela ionship be ween b eas eeding and PPD. Du ing p egnancy, lac a ion
begins wi h an inc ease in p oges e one and es ogens ha p epa es he b eas duc s
as pa o he s imula ion p ocess, bu in he i s days a e deli e y, he e is a apid
dec ease in bo h ha signals he s a o milk p oduc ion. This apid d op in p oges e one
and es ogen is a po en ial ca alys o he onse o mood labili y and he e o e PPD [
14
].
P oges e one de i a i es (p egnenolone and allop egnanolone) a ge hei e ec in egions
o he b ain ela ed o p ocessing emo ions. Es ablishing he exac ole o hese p oges e one
de i a i es in he de elopmen o PPD ea men may enligh en a new pe spec i e on
he gene al pa hophysiology o mood diso de s because allop egnanolone in e ac s wi h
GABA-A ecep o s and has signi ican an i-dep essan , an i-s ess, seda i e and anxioly ic
e ec s [
15
]. Some s udies indica e ha dep ession du ing p egnancy and pos pa um is
one o he ac o s ha can con ibu e o b eas eeding ailu e. O he s udies also sugges an
associa ion be ween b eas eeding and PPD, sugges ing ha PPD can educe b eas eeding
a es and ha b eas eeding can dec ease he isk o PPD. Addi ionally, he e is e idence
ha b eas eeding can p e en PPD o help symp oms o ecede mo e quickly. Howe e ,
he di ec ion o his associa ion is s ill unce ain [16,17].
Due o all hese easons, PPD has become a signi ican heal h issue ha a ec s no
only women’s heal h by inc easing ma e nal mo bidi y and mo ali y bu also a newbo n’s
eeding pa e ns and, consequen ly, beha iou al, emo ional and cogni i e de elopmen
du ing ea ly childhood [5,18].
G oup in e en ions du ing he pos pa um pe iod, du ing which women sha e a sa e
space o mu ual accep ance and unde s anding, ha e p o en e ec i e in imp o ing dep es-
si e symp oms and empowe ing women o cope wi h hei si ua ion [
19
]. Addi ionally,
he e a e also encou aging esul s demons a ing ha g oup in e en ions a e e ec i e a
main aining b eas eeding du ing he pos pa um pe iod, especially when his pee suppo
is combined wi h he leade ship o a heal hca e p o essional o an In e na ional Boa d
Ce i ied Lac a ion Consul an (IBCLC) [
20
]. Likewise, he e is e idence o he posi i e
impac ha b eas eeding has on women’s men al heal h by enhancing hei well-being,
inc easing pe cei ed sel -e icacy and p omo ing in e ac ion wi h he newbo n [21,22].
A he indi idual le el, a ec i e cha ac e is ics, o he “quali ies ha ep esen he
ypical ways o eeling o indi iduals”, a e pa icula ly impo an de e minan s o b eas -
eeding p ac ices [
23
]. One o hese key a ec i e cha ac e is ics is sel -e icacy, de ined by
Bandu a [
24
] as “ he belie in one’s capabili ies o o ganise and execu e he cou ses o ac ion
equi ed o p oduce ce ain achie emen s o esul s”. In con as , low le els o sel -e icacy
ha e been shown in p e ious s udies o be a isk ac o o he de elopmen o PPD [25].
Thus, he men al heal h o he mo he cons i u es a signi ican unde lying ac o linked
o ba ie s and educed a es o in en ion, ini ia ion and main enance o b eas eeding.
Gi en he e idence o a bidi ec ional associa ion be ween ma e nal men al heal h and
b eas eeding, i is essen ial o conside bo h aspec s when e alua ing he e ec i eness o
in e en ions aimed a imp o ing hese ou comes [16–27].
The p incipal aim o his s udy was o assess he e ec i eness o a midwi e-led b eas -
eeding suppo g oup in e en ion on he main enance o b eas eeding, he p e en ion o
Nu ien s 2024,16, 227 3 o 15
PPD and on gene al sel -e icacy. Addi ionally, he s udy aimed o explo e he ela ionship
be ween ma e nal dep ession and b eas eeding success.
2. Ma e ials and Me hods
2.1. S udy Design
This was a mul icen ic clus e andomised con olled ial wi h a con ol g oup
(CG) and an in e en ion g oup (IG) and was no blinded. This s udy was conduc ed
acco ding o he la es Consolida ed S anda ds o Repo ing T ials 2010 guidelines o
epo ing andomised con olled ials [
28
] and was comple ed as desc ibed in ou pub-
lished p o ocol [
29
]. P io o he s a o he ial, i was egis e ed in he In e na ional
S anda d Regis e ed Clinical/Social S udy Numbe egis y (T ial ID: ISRCTN17263529;
da e eco ded: 17 June 2020).
2.2. Pa icipan s and S udy A ea
Women who me he eligibili y c i e ia we e en olled as pa icipan s om p ima y
heal h cen es in Andalusia, Spain. Andalusia is an au onomous communi y wi h a bi h
a e o 7.72 pe 1000 inhabi an s (2021) [
30
] and 4,328,407 women o ep oduc i e age [
31
]
wi h he a e age age a which he i s child is bo n being 32.7 yea s [
32
]. The s udy in ol ed
popula ions om he p o inces o Se ille, Cadiz, Huel a, G anada and Jaen.
2.3. Inclusion and Exclusion C i e ia
The inclusion c i e ia included he ollowing:
•
Heal hy women pe o ming exclusi e o pa ial b eas eeding 10 days a e bi h and
who a ended an ena al lessons a he p ima y heal h cen e ;
•Women o e 18 yea s o age;
•Women who accep ed and signed he in o med consen o m.
Exclusion c i e ia included he ollowing:
•Human immunode iciency i us-posi i e;
•Cance ;
•Tube culosis in ec ion;
•No in en ion o b eas eed;
•Impossibili y o con aindica ion o b eas eed due o medical condi ions;
•
P ema u e and/o complica ed labou o newbo n in a neona al in ensi e ca e uni
du ing he i s mon h o li e;
•Communica ion di icul ies due o language ba ie s.
2.4. Sample Size
Acco ding o 2021 da a om he Na ional S a is ical Ins i u e o Spain, he e we e
a o al o 65,650 bi hs in Andalusia. Speci ically, he p o inces o Se ille (15,655 bi hs),
G anada (7083), Huel a (4227), Jaen (4499) and Cadiz (8904) accoun ed o 40,368 bi hs,
cons i u ing 61.79% o he o al bi hs in he egion [
33
]. The a e o exclusi e b eas eeding
(EBF) a 6 mon hs in Andalusia is 39% [
34
], which was conside ed he baseline alue
in he CG. An an icipa ed inc ease o 10%, as sugges ed by p e ious esea ch [
35
,
36
], in
he a e o EBF a 6 mon hs was es ablished. To achie e his di e ence be ween he wo
g oups, a wo- ailed hypo hesis was posed, wi h a powe o 80% and allowing o a ype I
e o o 5%. The necessa y sample size amoun ed o 371 women dis ibu ed be ween he
wo s udy g oups.
2.5. Randomisa ion and Rec ui men
P ima y heal h cen es we e andomly assigned o ei he he IG o he CG ( ecei ing
usual ca e), conside ing whe he any o m o g oup b eas eeding suppo in e en ion
was al eady a ailable. The alloca ion o heal h cen es in o hese g oups was pe o med by
a esea ch echnician, who was independen o he esea che s esponsible o pa icipan
Nu ien s 2024,16, 227 4 o 15
ec ui men , using a andom sequence [
37
]. The echnician p o ided andom unique
iden i ie s o he heal h cen es, dis inguishing be ween hose belonging o he CG and IG.
Subsequen ly, he women we e again andomised ollowing a simple s a egy (1:1) a
35–37 weeks o ges a ion by he collabo a ing p ima y heal h cen e midwi es. Finally, each
pa icipan ecei ed an iden i ica ion code based on he g oup o which she was assigned.
2.6. In e en ion
Pa icipan s in he CG ecei ed s anda d ca e in e ms o ma e nal educa ion and pos -
pa um isi s, ollowing he guidelines ou lined in he P o ocol o Ca e du ing P egnancy,
Childbi h and Pue pe ium by he Andalusian Heal h and Social Wel a e Council [
38
],
simila o he women in he IG. Wi hin he ini ial 10 days a e gi ing bi h, hey unde wen
a one-on-one isi wi h he midwi e o add ess indi idual conce ns. Addi ionally, women
had he oppo uni y o eques indi idual pos pa um consul a ions wi h he designa ed
midwi e a hei heal h cen e as needed.
Women in he IG ecei ed he usual p ena al and pos pa um ca e, jus like hose in he
CG. Subsequen ly, hey engaged in mon hly 2 h in-pe son and/o i ual g oup sessions
known as b eas eeding suppo g oups, du ing which he midwi e assumed he oles
o leade and mode a o . These sessions encompassed an educa ional elemen , ea u ing
heo e ical and p ac ical p esen a ions ela ed o b eas eeding and aligned wi h he ecom-
menda ions o he Baby-F iendly Hospi al Ini ia i e [
39
]. They also included mo i a ional
and social o pee suppo componen s es ablished wi hin he g oup. Consequen ly, on
a mon hly basis, women ecei ed suppo om an o ganised and p oac i e p o essional.
In addi ion o hese mon hly ga he ings, pa icipan s had he oppo uni y o in e ac wi h
each o he , connec wi h o he b eas eeding women and communica e wi h he designa ed
midwi e h ough a Facebook™ and/o Wha sApp™ g oup speci ically c ea ed o his
pu pose. This s eng hened pee suppo , and que ies ega ding he opic we e add essed
using in o ma ion and communica ion echnologies [
40
]. Simila ly, pa icipa ing women
e ained he op ion o eques indi idual consul a ions wi h he designa ed midwi e on
demand, simila o hose ecei ing s anda d ca e.
2.7. Assessmen
Sociodemog aphic and obs e ic clinical da a we e collec ed by a ques ionnai e de-
signed o his pu pose ia a web applica ion. Inco ec o incomple e da a we e co ec ed
ia di ec consul a ion wi h pa icipan s o we e collec ed om hei medical eco ds wi h
hei consen . The da a collec ed included he ollowing:
•
Sociodemog aphic a iables: ma e nal age, coun y o o igin, ci il s a us (single,
ma ied, sepa a ed, widow), educa ional le el (none, p ima y school, seconda y
school, uni e si y), employmen s a us (sel -employed, employed, unemployed);
•
Obs e ic a iables: pa i y (p imipa ous, mul ipa ous), ges a ional age, labou on-
se (induc ion, spon aneous), ype o bi h (eu ocic, ins umen al, elec i e caesa ean
sec ion, eme gen caesa ean sec ion), newbo n sex, bi h weigh .
The ype o b eas eeding was eco ded a hospi al discha ge, as well as a h ee
es ablished ollow-up ime poin s: 10 days pos pa um (T1), 2 mon hs pos pa um (T2)
and 4 mon hs pos pa um (T3). Dis inc ions we e made be ween EBF, b eas eeding wi h
occasional supplemen a ion o o mula, mixed eeding and o mula eeding.
PPD was measu ed using he Edinbu gh Pos na al Dep ession Scale (EPDS) designed
by Cox e al. [
41
] in 1987 and alida ed o he Spanish popula ion by Ga cía-Es e e
e al. [
42
] in 2003. This is a 10-i em sel - epo ed scale in which women indica e how hey
el in he las 7 days. The scale is s uc u ed in o h ee ac o s: anhedonia (i ems 1, 2 and
10), anxie y (i ems 3–6) and dep essi e symp oma ology (i ems 7–9) [
43
]. The minimum
possible sco e is 0, and he maximum is 30. The bes cu -o o he Spanish alida ion o he
EPDS was 10/11 o combined majo and mino dep ession, he sensi i i y was 79% and he
speci ici y was 95.5%, wi h a posi i e p edic i e alue o 63.2% and a nega i e p edic i e
alue o 97.7%. A his cu -o , all cases o majo dep ession we e de ec ed. The a ea unde
Nu ien s 2024,16, 227 5 o 15
he ecei e ope a ing cha ac e is ic cu e was 0.976 (p= 0.001) wi h an asymp o ic 95%
con idence in e al be ween 0.968 and 0.984 [42].
Gene al sel -e icacy was measu ed using he Gene al Sel -e icacy Scale (GSE) de-
signed by Baessle and Schwa ce [
44
] in 1996. I was alida ed o he Spanish popula ion
by Sanjuán e al. [
45
]. This scale assesses he endu ing sense o pe sonal compe ence o
e ec i ely handle a wide a ie y o s ess ul si ua ions. I is a unidimensional scale wi h
10 Like - ype
ques ions [
44
]. A change in he o iginal esponse o m (10-poin Like - ype
scale ins ead o a 4-poin scale) was in oduced in o de o adap he scale o o he esea ch
ins umen s. The eliabili y o he Spanish e sion o he GSE, as measu ed by he C onbach
alpha coe icien , was 0.87 [45].
The main con ol and ou come a iables we e measu ed be o e he s a o he in e -
en ion (baseline) and a 2- and 4-mon h ollow-ups.
2.8. Da a Collec ion
The en olmen o pa icipan s commenced in Oc obe 2021 and concluded in May
2023. This p ocess was pe o med by he midwi es o e seeing each heal h cen e. These
midwi es unde wen p io aining o he p ojec and ecei ed guidance om a esea ch
echnician midwi e associa ed wi h he p ojec bu no di ec ly in ol ed in he in e en ion.
The designa ed midwi e a he heal h cen e, du ing consul a ions wi h eligible women,
p o ided in o ma ion abou he s udy’s na u e and objec i es, as well as de ails ega ding
he ollow-up p ocedu es. Once pa icipan s p o ided in o ma ion ia he p ojec ’s web
applica ion, hey ag eed o pa icipa e and signed he in o med consen o m in duplica e.
The web applica ion au oma ically sen hem eminde messages and emails a he h ee
e alua ion ime poin s es ablished in he s udy.
The da a ela ing o elec onic ollow-up we e coded and sa egua ded by he esea ch
eam. All da a we e s o ed in an elec onic da abase accessible only o membe s o he
esea ch eam.
2.9. Da a Analysis
Desc ip i e da a analyses we e conduc ed o cha ac e ise he a iables. Baseline
cha ac e is ics we e compa ed be ween he g oup expe iencing po en ial losses du ing
ollow-up and he g oup comple ing ollow-up using c oss- abula ion analysis. Means we e
compa ed using Fishe ’s exac o - es s, as app op ia e. Associa ions be ween baseline and
childbi h a iables and EBF main enance a 10 days, 2 mon hs and 4 mon hs pos pa um
we e examined using c oss- abula ion analysis.
A pe -p o ocol analysis was pe o med. Chi-squa e o Fishe ’s exac es s and ANOVA
o - es s, as app op ia e, we e employed o mean compa isons. To assess he e ec o
he in e en ion on EBF main enance a a ious pos pa um ime poin s, c oss- abula ion
analysis and chi-squa e es s we e u ilised. Addi ionally, a mul i a ia e logis ic model was
employed o calcula e adjus ed odds a ios and hei 95% con idence in e als o each
ime poin .
The assump ion ha a iables we e no mally dis ibu ed was checked using he
Kolmogo o –Smi no es . G oup homogenei y analyses based on baseline and childbi h
a iables we e conduc ed using c oss- abula ion analysis, u ilising chi-squa e o Fishe ’s
exac es s as needed. ANOVA and - es s we e employed o mean compa isons.
Da a analysis was conduc ed using SPSS . 28.1 o Windows (IBM Co p. 2018, A monk,
NY, USA) and R (R P ojec 2019, e sion 4.0.2). The h eshold o s a is ical signi icance
was se a p< 0.05.
2.10. E hical Conside a ions
Be o e beginning he s udy, i was app o ed by he Resea ch E hics Commi ees o he
Vi gen Maca ena and Vi gen del Rocío hospi als (Se ille, Spain) on 13 Ma ch 2021 (Code
2722-N-20).
Nu ien s 2024,16, 227 6 o 15
Pa icipa ion in he p ojec was olun a y, as was he pa icipa ion eques . Ve bal and
w i en in o med consen in o ma ion was p o ided o e e y pa icipan in he s udy. The
s udy was designed acco ding o Spanish Law No. 14/2007 o 3 July ega ding biomedical
esea ch and complied wi h he s udy sui abili y equi emen s and wi h he p ocedu e
ega ding he s udy objec i es. The da a we e anonymously handled acco ding o he
Spanish O ganic Law on P o ec ion o Pe sonal Da a and Gua an ee o Digi al Righ s
(Spanish O ganic Law 3/2018).
3. Resul s
3.1. Cha ac e is ics o he Sample
A o al o 512 pa icipan s we e ini ially selec ed, wi h 130 (25.4%) excluded om
andomisa ion o he ollowing easons: 73 (56.2%) we e no b eas eeding hei newbo ns
and 57 (43.8%) declined ollow-up in he i s 10 days pos pa um.
The analysis ocused on a o al sample o 382 mo he –child dyads, andomly dis-
ibu ed, wi h 151 (39.5%) in he CG and 231 (60.5%) in he IG. The e we e 51 (13.35%)
d opou s be ween T1 and T2 (n= 331), 27 (7.06%) o hem due o discon inua ion o b eas -
eeding. In addi ion, 28 pa icipan s (7.32%) d opped ou be ween T2 and T3 (n= 303),
mo i a ed by discon inua ion o b eas eeding, esul ing in a o al o 79 pa icipan s who
did no con inue esponding o su eys (Figu e 1).
Nu ien s 2024, 16, x FOR PEER REVIEW 7 o 16
Figu e 1. Pa icipan selec ion lowcha .
We compa ed baseline cha ac e is ics be ween he d opou g oup (n = 79 [CG: 29; IG:
50]) and he inal analysed g oup (n = 303). Fishe ’s exac and - es s we e used, as app o-
p ia e o a iable ypes, o compa e he g oups. We obse ed ha only hose women in
he IG d opou g oup had a lowe a e o uni e si y educa ion compa ed o he ollow-up
g oup (52.0% s. 66.9%); his diffe ence was s a is ically signi ican (p = 0.038). Thus, de-
spi e hese losses, g oup homogenei y was main ained, indica ing hei andom o igin.
Figu e 1. Pa icipan selec ion lowcha .
Nu ien s 2024,16, 227 7 o 15
We compa ed baseline cha ac e is ics be ween he d opou g oup (n= 79 [CG: 29;
IG: 50]) and he inal analysed g oup (n= 303). Fishe ’s exac and - es s we e used, as
app op ia e o a iable ypes, o compa e he g oups. We obse ed ha only hose women
in he IG d opou g oup had a lowe a e o uni e si y educa ion compa ed o he ollow-
up g oup (52.0% s. 66.9%); his di e ence was s a is ically signi ican (p= 0.038). Thus,
despi e hese losses, g oup homogenei y was main ained, indica ing hei andom o igin.
3.2. Sociodemog aphic and Obs e ic–Neona al Va iables
The pa icipan s had a mean age o 33.4
±
4.7 yea s, wi h 93.5% (357/382) bo n in
Spain. The majo i y had a uni e si y educa ion (64.4%), we e ma ied (55.0%) and had
gain ul employmen (61.5%). The mean ges a ional age a bi h was 39.5
±
1.2 weeks, and
53.9% (206/382) o pa icipan s we e p imipa ous, wi h 60.7% (232/382) expe iencing a
spon aneous onse o labou culmina ing in aginal deli e y (61.8%). The a e age bi h
weigh was 3271 ±434.3 g.
The ela i e a e o b eas eeding expe ience was 38.4% (58/151) in he CG and 44.6%
(103/231) in he IG. We did no ind s a is ically signi ican di e ences be ween he so-
ciodemog aphic o obs e ic–neona al cha ac e is ics o he wo g oups, excep o ea ly
skin- o-skin con ac (p= 0.028) and eeding ype a 4 mon hs (p< 0.001; Table 1).
Table 1. Dis ibu ions o baseline a iables in con ol and in e en ion g oups (n= 382).
Con ol G oup
n= 151 (39.5%)
In e en ion G oup
n= 231 (60.5%) p-Value *
n%n%
Coun y o o igin Spain 142 94 215 93.1 0.709
Fo eign 9 6 16 6.9
Ci il s a us
Single 73 48.3 95 41.1
0.326
Ma ied 76 50.3 134 58
Sepa a e 2 1.3 2 0.9
Widow 0 0 0 0
Educa ional le el
None 0 0 1 0.4
0.846
P ima y school 5 3.3 9 3.9
Seconda y school 47 31.1 74 32
Uni e si y 99 65.6 147 63.6
Employmen s a us
Sel -employed 11 7.3 27 11.7
0.353
Employed 97 64.2 138 59.7
Unemployed 43 28.5 66 28.6
Pa i y P imipa ous 87 57.6 119 51.5 0.242
Mul ipa ous 64 42.4 112 48.5
P e ious BF expe ience No 93 61.6 128 55.4 0.232
Yes 58 38.4 103 44.6
Labou onse Induc ion 61 40.4 89 38.5 0.715
Spon aneous 90 59.6 142 61.5
Type o bi h
Eu ocic 96 63.6 140 60.6
0.411
Ins umen al 26 17.2 51 22.1
Elec i e CS 5 3.3 12 5.2
Eme gen CS 24 15.9 28 12.1
E-SSC No 25 16.6 21 9.1 0.028
Yes 126 83.4 210 90.9
Newbo n sex Male 79 52.3 116 50.2 0.688
Female 72 47.7 115 49.8
Nu ien s 2024,16, 227 8 o 15
Table 1. Con .
Con ol G oup
n= 151 (39.5%)
In e en ion G oup
n= 231 (60.5%) p-Value *
n%n%
Type o eeding a discha ge
(n= 382)
EBF 121 80.1 178 77.1
0.841
BF wi h OH 17 11.3 32 13.8
Mixed 13 8.6 21 9.1
Fo mula - - - -
Type o eeding T1
(n= 382)
EBF 118 78.1 180 77.9
0.960
BF wi h OH 20 13.3 31 13.4
Mixed 13 8.6 20 8.7
Fo mula - - - -
Type o eeding T2
(n= 331)
EBF 84 64.1 146 73
0.335
BF wi h OH 14 10.7 18 9
Mixed 19 14.5 23 11.5
Fo mula 14 10.7 13 6.5
Type o eeding T3
(n= 303)
EBF 61 50 128 69.9
<0.001
BF wi h OH 13 10.7 21 11.60
Mixed 22 18 12 6.62
Fo mula 26 21.3 20 10.9
Quan i a i e Va iables G oup nMean SD p- alue **
Ma e nal age (yea ) CG 151 33.28 5.03 0.063
IG 231 33.50 4.41
Ges a ional age (week) CG 151 39.46 1.38 0.820
IG 231 39.45 1.14
Bi h weigh (g am) CG 151 3299 430 0.819
IG 230 3253 437
EPDS T1
(n= 382)
CG 151 12.65 3.68 0.090
IG 231 12.11 3.26
EPDS T2
(n= 331)
CG 131 12.50 3.66 0.487
IG 200 12.62 3.70
EPDS T3
(n= 303)
CG 122 13.39 4.00 0.116
IG 181 12.49 3.63
GSE T1
(n= 382)
CG 151 78.59 14.36 0.699
IG 231 79.58 13.87
GSE T2
(n= 331)
CG 131 75.65 14.39 0.607
IG 200 77.73 14.81
GSE T3
(n= 303)
CG 122 75.36 15.17 0.881
IG 181 76.46 15.26
* Chi-squa ed es ; ** ANOVA; BF: b eas eeding; CS: caesa ean sec ion; E-SSC: ea ly skin- o-skin con ac ; EBF:
exclusi e b eas eeding; BF wi h OH: b eas eeding wi h occasional help; T1: 10 days pos pa um; T2: 2 mon hs
pos pa um; T3: 4 mon hs pos pa um; SD: s anda d de ia ion; EPDS: Edinbu g Pos na al Dep ession Scale; GSE:
Gene al Sel -e icacy Scale; CG: con ol g oup; IG: in e en ion g oup.
Du ing he ollow-up pe iod, we obse ed a g adual educ ion in he b eas eeding
a e om 78.0% (298/382) a 10 days o 69.5% (230/331) a 2 mon hs and 62.4% (189/303)
a 4 mon hs pos pa um. S a is ically signi ican di e ences we e ound be ween he a es
o b eas eeding in he CG (50.0%) and he IG (70.7%) a 4 mon hs pos pa um (p< 0.001;
Table 2).
Nu ien s 2024,16, 227 9 o 15
Table 2. Analysis o he be ween-g oup di e ences in he main enance o exclusi e b eas eeding.
G oup To al p-Value *
CG IG
EBF T1
(n= 382)
No n33 51 84
0.959
% 21.90 22.10 22.00
Yes n118 180 298
% 78.10 77.90 78.00
EBF T2
(n= 331)
No n47 54 101
0.086
% 35.90 27.00 30.50
Yes n84 146 230
% 64.10 73.00 69.50
EBF T3
(n= 303)
No n61 53 114
<0.001
% 50.00 29.28 37.62
Yes n61 128 189
% 50.00 70.72 62.38
* Chi-squa e es ; CG: con ol g oup; IG: in e en ion g oup; EBF: exclusi e b eas eeding; T1: 10 days pos pa um;
T2: 2 mon hs pos pa um; T3: 4 mon hs pos pa um.
S a is ically signi ican di e ences be ween he g oups we e obse ed in PPD a
4 mon hs pos pa um, wi h a lowe mean sco e on he EPDS in he IG han he CG
(12.49 ±3.6 s. 13.39 ±4.0; p= 0.044; Table 3).
Table 3. E ec i eness o he in e en ion a educing pos pa um dep ession, as e idenced by
be ween-g oup di e ences.
nMean SD 95% CI Minimum Maximum Fp-Value *
Uppe Limi Lowe Limi
EPDS T1
CG 151 12.65 3.686 12.06 13.24 6 23
2.258 0.134
IG 231 12.11 3.268 11.68 12.53 6 23
To al 382 12.32 3.445 11.98 12.67 6 23
EPDS T2
CG 131 12.50 3.666 11.87 13.14 6 24
0.072 0.789
IG 200 12.62 3.702 12.10 13.13 6 22
To al 331 12.57 3.683 12.17 12.97 6 24
EPDS T3
CG 122 13.39 4.001 12.67 14.10 6 23
4.077 0.044
IG 181 12.49 3.636 11.96 13.02 6 24
To al 303 12.85 3.805 12.42 13.28 6 24
* ANOVA; SD: s anda d de ia ion; CI: con idence in e al; EPDS: Edinbu g Pos na al Dep ession Scale; T1: 10 days
pos pa um; T2: 2 mon hs pos pa um; T3: 4 mon hs pos pa um; CG: con ol g oup; IG: in e en ion g oup.
We examined he ela ionships be ween he main enance o EBF and bo h EPDS and
GSE sco es du ing he s udy pe iod. We obse ed s a is ically signi ican di e ences in he
GSE sco es o women who did and did no pe o m EBF only a T2 and T3, wi h women
pe o ming EBF ob aining highe sco es (78.1
±
14.3 s. 74.3
±
15.2 a T2 [p= 0.014];
78.3 ±14.4
s. 72.4
±
15.9 a T3 [p< 0.001]; Table 4). S a is ically signi ican di e ences
we e obse ed in he EPDS sco es o women who did and did no pe o m EBF only a T2
and T3, wi h lowe mean sco es in women pe o ming EBF (12.2
±
3.5 s. 13.5
±
3.9 a T2
[p= 0.002]; 12.1 ±3.6 s. 14.1 ±3.8 a T3 [p< 0.001]; Table 4).
