Evaluation of the Impact of a Midwife-Led Breastfeeding Group Intervention on Prevention of Postpartum Depression: A Multicentre Randomised Clinical Trial

Citation: Rodríguez-Gallego, I.; Vila-Candel, R.; Corrales-Gutierrez, I.; Gomez-Baya, D.; Leon-Larios, F. Evaluation of the Impact of a MidwifeLed Breastfeeding Group Intervention on Prevention of Postpartum Depression: A Multicentre Randomised Clinical Trial. Nutrients 2024,16, 227. https://doi.org/10.3390/nu16020227 Academic Editor: Tamás Decsi Received: 23 December 2023 Revised: 6 January 2024 Accepted: 8 January 2024 Published: 10 January 2024 Copyright: © 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https:// creativecommons.org/licenses/by/ 4.0/). nutrients Article Evaluation of the Impact of a Midwife-Led Breastfeeding Group Intervention on Prevention of Postpartum Depression: A Multicentre Randomised Clinical Trial Isabel Rodríguez-Gallego 1,2 , Rafael Vila-Candel 3,4,5, * , Isabel Corrales-Gutierrez 6,7, * , Diego Gomez-Baya 8 and Fatima Leon-Larios 9 1 Foetal Medicine, Genetics and Reproduction Unit, Virgen del Rocío University Hospital, 41009 Seville, Spain; [email protected] 2Red Cross Nursing University Centre, University of Seville, 41013 Seville, Spain 3Faculty of Health Sciences, Universidad Internacional de Valencia (VIU), 46002 Valencia, Spain 4La Ribera Primary Health Department, 46600 Alzira, Spain 5Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO), 46020 Valencia, Spain 6Surgery Department, Faculty of Medicine, University of Seville, 41009 Seville, Spain 7Foetal Medicine Unit, Virgen Macarena University Hospital, 41009 Seville, Spain 8Department of Social, Developmental and Educational Psychology, Universidad de Huelva, 21007 Huelva, Spain; [email protected] 9Nursing Department, School of Nursing, Physiotherapy and Podiatry, University of Seville, 41009 Seville, Spain; [email protected] *Correspondence: [email protected] (R.V.-C.); [email protected] (I.C.-G.) Abstract: Postpartum depression is a significant health issue affecting both mothers and newborns during the postpartum period. Group support interventions during this period have proven effective in helping women cope with depression and improving breastfeeding rates. This study aimed to assess the effectiveness of a midwife-led breastfeeding support group intervention on breastfeeding rates, postpartum depression and general self-efficacy. This was a multicentric cluster randomised controlled trial with control and intervention groups and was not blinded. It was conducted in Andalusia (southern Spain) from October 2021 to May 2023. A total of 382 women participated in the study. The results showed a significant difference in exclusive breastfeeding rates at 4 months postpartum between the groups (control 50% vs. intervention 69.9%; p< 0.001). Additionally, there was a lower mean score on the Edinburgh Postnatal Depression Scale in the intervention group ( 12.49 ±3.6 vs. 13.39 ± 4.0; p= 0.044). Similarly, higher scores of general self-efficacy were observed among breastfeeding women at 2 and 4 months postpartum (77.73 ± 14.81; p= 0.002 and 76.46 ±15.26; p< 0.001, respectively). In conclusion, midwife-led breastfeeding support groups enhanced self-efficacy, prolonged breastfeeding and reduced postpartum depression 4 months after giving birth. Keywords: breastfeeding; support group; lactation; self-help group; postpartum depression; general self-efficacy; women’s mental health 1. Introduction The postpartum period entails significant physical, psychosocial and social changes for women as they adapt to a new situation. Therefore, it is known as a period of special vulnerability related to maternal mental health [ 1 ]. Approximately 9.6% to 19.2% of mothers experience a major or minor depressive episode during the first 12 months after childbirth [ 2 ]. Thus, one of the main complications during the postpartum period is postpartum depression (PPD) [3,4]. Globally, one in five women is estimated to develop PPD. However, the prevalence of PPD varies significantly between geographic areas and cultures. Southern Africa has Nutrients 2024,16, 227. https://doi.org/10.3390/nu16020227 https://www.mdpi.com/journal/nutrients Nutrients 2024,16, 227 2 of 15 the highest reported prevalence (39.96%), eastern Europe (16.62%) and southern Europe (16.34%) show intermediate prevalence and Oceania (11.11%) has some of the lowest reported figures [ 5 – 7 ]. Furthermore, countries with higher income and developed countries have a significantly lower prevalence than lower income or developing countries [ 5 ]. However, these figures may underestimate the true extent of the problem due to barriers to detection and the stigma associated with mental illnesses in the perinatal context. Some estimates suggest that more than 50% of women with PPD are not diagnosed [ 6 ]. PPD generally occurs within 4 weeks after delivery and can last 6 months or longer after delivery, although some authors indicate that it could last up to 2 years after delivery [4,8–10]. Breastfeeding provides multiple demonstrated benefits on the physical, cognitive and social levels for both the mother and the newborn [ 11 – 13 ]. However, the psychological benefits, especially those concerning PPD, are still largely unknown. There is a complex physiological relationship between breastfeeding and PPD. During pregnancy, lactation begins with an increase in progesterone and estrogens that prepares the breast ducts as part of the stimulation process, but in the first days after delivery, there is a rapid decrease in both that signals the start of milk production. This rapid drop in progesterone and estrogen is a potential catalyst for the onset of mood lability and therefore PPD [ 14 ]. Progesterone derivatives (pregnenolone and allopregnanolone) target their effect in regions of the brain related to processing emotions. Establishing the exact role of these progesterone derivatives in the development of PPD treatment may enlighten a new perspective on the general pathophysiology of mood disorders because allopregnanolone interacts with GABA-A receptors and has significant anti-depressant, anti-stress, sedative and anxiolytic effects [ 15 ]. Some studies indicate that depression during pregnancy and postpartum is one of the factors that can contribute to breastfeeding failure. Other studies also suggest an association between breastfeeding and PPD, suggesting that PPD can reduce breastfeeding rates and that breastfeeding can decrease the risk of PPD. Additionally, there is evidence that breastfeeding can prevent PPD or help symptoms to recede more quickly. However, the direction of this association is still uncertain [16,17]. Due to all these reasons, PPD has become a significant health issue that affects not only women’s health by increasing maternal morbidity and mortality but also a newborn’s feeding patterns and, consequently, behavioural, emotional and cognitive development during early childhood [5,18]. Group interventions during the postpartum period, during which women share a safe space of mutual acceptance and understanding, have proven effective in improving depressive symptoms and empowering women to cope with their situation [ 19 ]. Additionally, there are also encouraging results demonstrating that group interventions are effective at maintaining breastfeeding during the postpartum period, especially when this peer support is combined with the leadership of a healthcare professional or an International Board Certified Lactation Consultant (IBCLC) [ 20 ]. Likewise, there is evidence of the positive impact that breastfeeding has on women’s mental health by enhancing their well-being, increasing perceived self-efficacy and promoting interaction with the newborn [21,22]. At the individual level, affective characteristics, or the “qualities that represent the typical ways of feeling of individuals”, are particularly important determinants of breastfeeding practices [ 23 ]. One of these key affective characteristics is self-efficacy, defined by Bandura [ 24 ] as “the belief in one’s capabilities to organise and execute the courses of action required to produce certain achievements or results”. In contrast, low levels of self-efficacy have been shown in previous studies to be a risk factor for the development of PPD [25]. Thus, the mental health of the mother constitutes a significant underlying factor linked to barriers and reduced rates of intention, initiation and maintenance of breastfeeding. Given the evidence of a bidirectional association between maternal mental health and breastfeeding, it is essential to consider both aspects when evaluating the effectiveness of interventions aimed at improving these outcomes [16–27]. The principal aim of this study was to assess the effectiveness of a midwife-led breastfeeding support group intervention on the maintenance of breastfeeding, the prevention of Nutrients 2024,16, 227 3 of 15 PPD and on general self-efficacy. Additionally, the study aimed to explore the relationship between maternal depression and breastfeeding success. 2. Materials and Methods 2.1. Study Design This was a multicentric cluster randomised controlled trial with a control group (CG) and an intervention group (IG) and was not blinded. This study was conducted according to the latest Consolidated Standards of Reporting Trials 2010 guidelines for reporting randomised controlled trials [ 28 ] and was completed as described in our published protocol [ 29 ]. Prior to the start of the trial, it was registered in the International Standard Registered Clinical/Social Study Number registry (Trial ID: ISRCTN17263529; date recorded: 17 June 2020). 2.2. Participants and Study Area Women who met the eligibility criteria were enrolled as participants from primary health centres in Andalusia, Spain. Andalusia is an autonomous community with a birth rate of 7.72 per 1000 inhabitants (2021) [ 30 ] and 4,328,407 women of reproductive age [ 31 ] with the average age at which the first child is born being 32.7 years [ 32 ]. The study involved populations from the provinces of Seville, Cadiz, Huelva, Granada and Jaen. 2.3. Inclusion and Exclusion Criteria The inclusion criteria included the following: • Healthy women performing exclusive or partial breastfeeding 10 days after birth and who attended antenatal lessons at the primary health center; •Women over 18 years of age; •Women who accepted and signed the informed consent form. Exclusion criteria included the following: •Human immunodeficiency virus-positive; •Cancer; •Tuberculosis infection; •No intention to breastfeed; •Impossibility or contraindication to breastfeed due to medical conditions; • Premature and/or complicated labour or newborn in a neonatal intensive care unit during the first month of life; •Communication difficulties due to language barriers. 2.4. Sample Size According to 2021 data from the National Statistical Institute of Spain, there were a total of 65,650 births in Andalusia. Specifically, the provinces of Seville (15,655 births), Granada (7083), Huelva (4227), Jaen (4499) and Cadiz (8904) accounted for 40,368 births, constituting 61.79% of the total births in the region [ 33 ]. The rate of exclusive breastfeeding (EBF) at 6 months in Andalusia is 39% [ 34 ], which was considered the baseline value in the CG. An anticipated increase of 10%, as suggested by previous research [ 35 , 36 ], in the rate of EBF at 6 months was established. To achieve this difference between the two groups, a two-tailed hypothesis was posed, with a power of 80% and allowing for a type I error of 5%. The necessary sample size amounted to 371 women distributed between the two study groups. 2.5. Randomisation and Recruitment Primary health centres were randomly assigned to either the IG or the CG (receiving usual care), considering whether any form of group breastfeeding support intervention was already available. The allocation of health centres into these groups was performed by a research technician, who was independent of the researchers responsible for participant Nutrients 2024,16, 227 4 of 15 recruitment, using a random sequence [ 37 ]. The technician provided random unique identifiers to the health centres, distinguishing between those belonging to the CG and IG. Subsequently, the women were again randomised following a simple strategy (1:1) at 35–37 weeks of gestation by the collaborating primary health centre midwives. Finally, each participant received an identification code based on the group to which she was assigned. 2.6. Intervention Participants in the CG received standard care in terms of maternal education and postpartum visits, following the guidelines outlined in the Protocol for Care during Pregnancy, Childbirth and Puerperium by the Andalusian Health and Social Welfare Council [ 38 ], similar to the women in the IG. Within the initial 10 days after giving birth, they underwent a one-on-one visit with the midwife to address individual concerns. Additionally, women had the opportunity to request individual postpartum consultations with the designated midwife at their health centre as needed. Women in the IG received the usual prenatal and postpartum care, just like those in the CG. Subsequently, they engaged in monthly 2 h in-person and/or virtual group sessions known as breastfeeding support groups, during which the midwife assumed the roles of leader and moderator. These sessions encompassed an educational element, featuring theoretical and practical presentations related to breastfeeding and aligned with the recommendations of the Baby-Friendly Hospital Initiative [ 39 ]. They also included motivational and social or peer support components established within the group. Consequently, on a monthly basis, women received support from an organised and proactive professional. In addition to these monthly gatherings, participants had the opportunity to interact with each other, connect with other breastfeeding women and communicate with the designated midwife through a Facebook™ and/or WhatsApp™ group specifically created for this purpose. This strengthened peer support, and queries regarding the topic were addressed using information and communication technologies [ 40 ]. Similarly, participating women retained the option to request individual consultations with the designated midwife on demand, similar to those receiving standard care. 2.7. Assessment Sociodemographic and obstetric clinical data were collected by a questionnaire designed for this purpose via a web application. Incorrect or incomplete data were corrected via direct consultation with participants or were collected from their medical records with their consent. The data collected included the following: • Sociodemographic variables: maternal age, country of origin, civil status (single, married, separated, widow), educational level (none, primary school, secondary school, university), employment status (self-employed, employed, unemployed); • Obstetric variables: parity (primiparous, multiparous), gestational age, labour onset (induction, spontaneous), type of birth (eutocic, instrumental, elective caesarean section, emergent caesarean section), newborn sex, birth weight. The type of breastfeeding was recorded at hospital discharge, as well as at three established follow-up time points: 10 days postpartum (T1), 2 months postpartum (T2) and 4 months postpartum (T3). Distinctions were made between EBF, breastfeeding with occasional supplementation of formula, mixed feeding and formula feeding. PPD was measured using the Edinburgh Postnatal Depression Scale (EPDS) designed by Cox et al. [ 41 ] in 1987 and validated for the Spanish population by García-Esteve et al. [ 42 ] in 2003. This is a 10-item self-reported scale in which women indicate how they felt in the last 7 days. The scale is structured into three factors: anhedonia (items 1, 2 and 10), anxiety (items 3–6) and depressive symptomatology (items 7–9) [ 43 ]. The minimum possible score is 0, and the maximum is 30. The best cut-off of the Spanish validation of the EPDS was 10/11 for combined major and minor depression, the sensitivity was 79% and the specificity was 95.5%, with a positive predictive value of 63.2% and a negative predictive value of 97.7%. At this cut-off, all cases of major depression were detected. The area under Nutrients 2024,16, 227 5 of 15 the receiver operating characteristic curve was 0.976 (p= 0.001) with an asymptotic 95% confidence interval between 0.968 and 0.984 [42]. General self-efficacy was measured using the General Self-efficacy Scale (GSE) designed by Baessler and Schwarcer [ 44 ] in 1996. It was validated for the Spanish population by Sanjuán et al. [ 45 ]. This scale assesses the enduring sense of personal competence to effectively handle a wide variety of stressful situations. It is a unidimensional scale with 10 Likert-type questions [ 44 ]. A change in the original response form (10-point Likert-type scale instead of a 4-point scale) was introduced in order to adapt the scale to other research instruments. The reliability of the Spanish version of the GSE, as measured by the Cronbach alpha coefficient, was 0.87 [45]. The main control and outcome variables were measured before the start of the intervention (baseline) and at 2and 4-month follow-ups. 2.8. Data Collection The enrolment of participants commenced in October 2021 and concluded in May 2023. This process was performed by the midwives overseeing each health centre. These midwives underwent prior training for the project and received guidance from a research technician midwife associated with the project but not directly involved in the intervention. The designated midwife at the health centre, during consultations with eligible women, provided information about the study’s nature and objectives, as well as details regarding the follow-up procedures. Once participants provided information via the project’s web application, they agreed to participate and signed the informed consent form in duplicate. The web application automatically sent them reminder messages and emails at the three evaluation time points established in the study. The data relating to electronic follow-up were coded and safeguarded by the research team. All data were stored in an electronic database accessible only to members of the research team. 2.9. Data Analysis Descriptive data analyses were conducted to characterise the variables. Baseline characteristics were compared between the group experiencing potential losses during follow-up and the group completing follow-up using cross-tabulation analysis. Means were compared using Fisher’s exact or t-tests, as appropriate. Associations between baseline and childbirth variables and EBF maintenance at 10 days, 2 months and 4 months postpartum were examined using cross-tabulation analysis. A per-protocol analysis was performed. Chi-square or Fisher’s exact tests and ANOVA or t-tests, as appropriate, were employed for mean comparisons. To assess the effect of the intervention on EBF maintenance at various postpartum time points, cross-tabulation analysis and chi-square tests were utilised. Additionally, a multivariate logistic model was employed to calculate adjusted odds ratios and their 95% confidence intervals for each time point. The assumption that variables were normally distributed was checked using the Kolmogorov–Smirnov test. Group homogeneity analyses based on baseline and childbirth variables were conducted using cross-tabulation analysis, utilising chi-square or Fisher’s exact tests as needed. ANOVA and t-tests were employed for mean comparisons. Data analysis was conducted using SPSS v. 28.1 for Windows (IBM Corp. 2018, Armonk, NY, USA) and R (R Project 2019, version 4.0.2). The threshold for statistical significance was set at p< 0.05. 2.10. Ethical Considerations Before beginning the study, it was approved by the Research Ethics Committees of the Virgen Macarena and Virgen del Rocío hospitals (Seville, Spain) on 13 March 2021 (Code 2722-N-20). Nutrients 2024,16, 227 6 of 15 Participation in the project was voluntary, as was the participation request. Verbal and written informed consent information was provided to every participant in the study. The study was designed according to Spanish Law No. 14/2007 of 3 July regarding biomedical research and complied with the study suitability requirements and with the procedure regarding the study objectives. The data were anonymously handled according to the Spanish Organic Law on Protection of Personal Data and Guarantee of Digital Rights (Spanish Organic Law 3/2018). 3. Results 3.1. Characteristics of the Sample A total of 512 participants were initially selected, with 130 (25.4%) excluded from randomisation for the following reasons: 73 (56.2%) were not breastfeeding their newborns and 57 (43.8%) declined follow-up in the first 10 days postpartum. The analysis focused on a total sample of 382 mother–child dyads, randomly distributed, with 151 (39.5%) in the CG and 231 (60.5%) in the IG. There were 51 (13.35%) dropouts between T1 and T2 (n= 331), 27 (7.06%) of them due to discontinuation of breastfeeding. In addition, 28 participants (7.32%) dropped out between T2 and T3 (n= 303), motivated by discontinuation of breastfeeding, resulting in a total of 79 participants who did not continue responding to surveys (Figure 1). Nutrients 2024, 16, x FOR PEER REVIEW 7 of 16 Figure 1. Participant selection flowchart. We compared baseline characteristics between the dropout group (n = 79 [CG: 29; IG: 50]) and the final analysed group (n = 303). Fisher’s exact and t-tests were used, as appropriate for variable types, to compare the groups. We observed that only those women in the IG dropout group had a lower rate of university education compared to the follow-up group (52.0% vs. 66.9%); this difference was statistically significant (p = 0.038). Thus, despite these losses, group homogeneity was maintained, indicating their random origin. Figure 1. Participant selection flowchart. Nutrients 2024,16, 227 7 of 15 We compared baseline characteristics between the dropout group (n= 79 [CG: 29; IG: 50]) and the final analysed group (n= 303). Fisher’s exact and t-tests were used, as appropriate for variable types, to compare the groups. We observed that only those women in the IG dropout group had a lower rate of university education compared to the followup group (52.0% vs. 66.9%); this difference was statistically significant (p= 0.038). Thus, despite these losses, group homogeneity was maintained, indicating their random origin. 3.2. Sociodemographic and Obstetric–Neonatal Variables The participants had a mean age of 33.4 ± 4.7 years, with 93.5% (357/382) born in Spain. The majority had a university education (64.4%), were married (55.0%) and had gainful employment (61.5%). The mean gestational age at birth was 39.5 ± 1.2 weeks, and 53.9% (206/382) of participants were primiparous, with 60.7% (232/382) experiencing a spontaneous onset of labour culminating in vaginal delivery (61.8%). The average birth weight was 3271 ±434.3 g. The relative rate of breastfeeding experience was 38.4% (58/151) in the CG and 44.6% (103/231) in the IG. We did not find statistically significant differences between the sociodemographic or obstetric–neonatal characteristics of the two groups, except for early skin-to-skin contact (p= 0.028) and feeding type at 4 months (p< 0.001; Table 1). Table 1. Distributions of baseline variables in control and intervention groups (n= 382). Control Group n= 151 (39.5%) Intervention Group n= 231 (60.5%) p-Value * n%n% Country of origin Spain 142 94 215 93.1 0.709 Foreign 9 6 16 6.9 Civil status Single 73 48.3 95 41.1 0.326 Married 76 50.3 134 58 Separate 2 1.3 2 0.9 Widow 0 0 0 0 Educational level None 0 0 1 0.4 0.846 Primary school 5 3.3 9 3.9 Secondary school 47 31.1 74 32 University 99 65.6 147 63.6 Employment status Self-employed 11 7.3 27 11.7 0.353 Employed 97 64.2 138 59.7 Unemployed 43 28.5 66 28.6 Parity Primiparous 87 57.6 119 51.5 0.242 Multiparous 64 42.4 112 48.5 Previous BF experience No 93 61.6 128 55.4 0.232 Yes 58 38.4 103 44.6 Labour onset Induction 61 40.4 89 38.5 0.715 Spontaneous 90 59.6 142 61.5 Type of birth Eutocic 96 63.6 140 60.6 0.411 Instrumental 26 17.2 51 22.1 Elective CS 5 3.3 12 5.2 Emergent 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 Newborn sex Male 79 52.3 116 50.2 0.688 Female 72 47.7 115 49.8 Nutrients 2024,16, 227 8 of 15 Table 1. Cont. Control Group n= 151 (39.5%) Intervention Group n= 231 (60.5%) p-Value * n%n% Type of feeding at discharge (n= 382) EBF 121 80.1 178 77.1 0.841 BF with OH 17 11.3 32 13.8 Mixed 13 8.6 21 9.1 Formula - - - - Type of feeding T1 (n= 382) EBF 118 78.1 180 77.9 0.960 BF with OH 20 13.3 31 13.4 Mixed 13 8.6 20 8.7 Formula - - - - Type of feeding T2 (n= 331) EBF 84 64.1 146 73 0.335 BF with OH 14 10.7 18 9 Mixed 19 14.5 23 11.5 Formula 14 10.7 13 6.5 Type of feeding T3 (n= 303) EBF 61 50 128 69.9 <0.001 BF with OH 13 10.7 21 11.60 Mixed 22 18 12 6.62 Formula 26 21.3 20 10.9 Quantitative Variables Group nMean SD p-value ** Maternal age (year) CG 151 33.28 5.03 0.063 IG 231 33.50 4.41 Gestational age (week) CG 151 39.46 1.38 0.820 IG 231 39.45 1.14 Birth weight (gram) 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-squared test; ** ANOVA; BF: breastfeeding; CS: caesarean section; E-SSC: early skin-to-skin contact; EBF: exclusive breastfeeding; BF with OH: breastfeeding with occasional help; T1: 10 days postpartum; T2: 2 months postpartum; T3: 4 months postpartum; SD: standard deviation; EPDS: Edinburg Postnatal Depression Scale; GSE: General Self-efficacy Scale; CG: control group; IG: intervention group. During the follow-up period, we observed a gradual reduction in the breastfeeding rate from 78.0% (298/382) at 10 days to 69.5% (230/331) at 2 months and 62.4% (189/303) at 4 months postpartum. Statistically significant differences were found between the rates of breastfeeding in the CG (50.0%) and the IG (70.7%) at 4 months postpartum (p< 0.001; Table 2). Nutrients 2024,16, 227 9 of 15 Table 2. Analysis of the between-group differences in the maintenance of exclusive breastfeeding. Group Total 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-square test; CG: control group; IG: intervention group; EBF: exclusive breastfeeding; T1: 10 days postpartum; T2: 2 months postpartum; T3: 4 months postpartum. Statistically significant differences between the groups were observed in PPD at 4 months postpartum, with a lower mean score on the EPDS in the IG than the CG (12.49 ±3.6 vs. 13.39 ±4.0; p= 0.044; Table 3). Table 3. Effectiveness of the intervention at reducing postpartum depression, as evidenced by between-group differences. nMean SD 95% CI Minimum Maximum Fp-Value * Upper Limit Lower Limit 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 Total 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 Total 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 Total 303 12.85 3.805 12.42 13.28 6 24 * ANOVA; SD: standard deviation; CI: confidence interval; EPDS: Edinburg Postnatal Depression Scale; T1: 10 days postpartum; T2: 2 months postpartum; T3: 4 months postpartum; CG: control group; IG: intervention group. We examined the relationships between the maintenance of EBF and both EPDS and GSE scores during the study period. We observed statistically significant differences in the GSE scores of women who did and did not perform EBF only at T2 and T3, with women performing EBF obtaining higher scores (78.1 ± 14.3 vs. 74.3 ± 15.2 at T2 [p= 0.014]; 78.3 ±14.4 vs. 72.4 ± 15.9 at T3 [p< 0.001]; Table 4). Statistically significant differences were observed in the EPDS scores of women who did and did not perform EBF only at T2 and T3, with lower mean scores in women performing EBF (12.2 ± 3.5 vs. 13.5 ± 3.9 at T2 [p= 0.002]; 12.1 ±3.6 vs. 14.1 ±3.8 at T3 [p< 0.001]; Table 4).