Effects of the enhanced recovery after surgery intervention for preventing postpartum depression: a protocol for systematic review and meta-analysis

STRENGTHS AND LIMITATIONS OF THIS STUDY

  • This systematic review and meta-analysis will be conducted in accordance with the guidelines in the Cochrane handbook for systematic reviews of interventions.

  • The overall quality of evidence will be appraised using the Grading of Recommendations Assessment, Development and Evaluation system.

  • The uncertain quality, sample size and heterogeneity of the included studies may limit the representativeness and determination of the results pooled in this meta-analysis.

Introduction

Postpartum depression (PPD) is a prevalent and debilitating mental disorder, affecting approximately 18% of pregnant women worldwide.1 2 It is commonly characterised by persistent feelings of sadness, hopelessness and loss of interest in daily activities, often accompanied by fatigue, sleep disturbances and suicidal tendencies.3 4 PPD not only deleteriously impacts the physical and mental health of mothers but also impairs the newborn and families.5 6 In addition, PPD also brings long-term adverse effects, potentially harming the cognitive, behavioural and social-emotional development of the children.7 8 As a consequence, PPD has become a global issue for public health owing to its disease burden, financial expenses and social hazards.9–11 In recent decades, the incidence of PPD has steadily risen, probably in relation to the increasing rates of caesarean section (CS).12 13 Additionally, surgical trauma could impose considerable physical and emotional stress on CS patients, which significantly increases the risk of PPD.14 Worldwide, CS has a huge volume with over 18 million procedures annually and will continue to increase in the near future, inevitably leading a critical challenge to the puerperas’ mental health.15 Therefore, it is of great clinical significance to explore effective treatment and preventive strategies to combat PPD, particularly in the CS population.

Despite great progress has been achieved in the pathogenesis of PPD, traditional treatment and interventions remain insufficient, with only half of PPD patients receiving adequate treatment.16 17 Meanwhile, recent evidence suggests that prevention is more acceptable than treatment for PPD and could yield dramatic benefits, especially in reducing the incidence of PPD and decreasing the financial burden.18 Thus, there is a growing focus concerning the prophylaxis of PPD for patients undergoing CS. Nevertheless, a relatively less effective strategy has been explored or succeed to translate into a meaningful approach to prevent PPD during the perioperation of CS. Given the convenient, cost-effective and patient compliance, it is preferable to exploit the potential intervention (eg, it has already been packaged for, tested with and found feasible and acceptable using healthcare as priority) that fits the CS perioperation.19

At the start of the 21st century, enhanced recovery after surgery (ERAS) was first implemented in surgical patients to alleviate the stress response and promote rehabilitation, improving the health outcomes and resource utilisation.20 21 Over the past decade, the adoption of ERAS in the obstetric patient population is gradually gaining popularity. As expected, ERAS applying to CS significantly reduced the postoperative complications and hospital stay, potentially leading to the saving in financial cost and time. Also, ERAS improved the postoperative pain, maternal–neonatal bonding and breast feeding coupled with increased patient satisfaction, all of which are closely related to the development of PPD.22 In addition, intriguing studies found that ERAS potentially relieves the state of anxiety and decrease the postoperative Self-Rating Depression Scale score in other surgical specialties.23 24 Thus, ERAS may plausibly protect against PPD with considerable flexibility and accessibility.25 26

Furthermore, encouraging findings showed that ERAS reduced the incidence of PPD and improved the Edinburgh Postnatal Depression Scale (EPDS) in CS patients, further making it a promising candidate to prevent PPD.27 Although the benefits of ERAS programmes have been shown up to some extent, a systematic review and meta-analysis with high-level evidence is still lacking. In this context, we will perform a systematic synthesis involving current body of evidence to assess the effectiveness of ERAS for the prevention of PPD in CS patients, simultaneously exploring the benefits for healthcare costs and healthcare systems. Furthermore, we hope that a comprehensive review in this area will provide a reference for the health authorities and promote the future clinical practice in this field.

Methods and analysis

The systematic review and meta-analysis will follow the guidelines of the Cochrane Collaboration Handbook for Systematic Reviews of Interventions and registered in the PROSPERO (CRD42023485929). This protocol is also developed in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols.28

Patient and public involvement

None.

Eligibility criteria

Type of studies

All randomised controlled trials (RCTs) and observational studies (prospective or retrospective cohort studies) assessing ERAS intervention for PPD will be included.

Type of participants

Patients underwent elective or emergency CS with or without PPD diagnosed through a validated depression score scale.

Type of interventions

In the experimental group, patients received ERAS intervention, mainly including preoperative preparation (patient education and counselling, minimising preoperative fasting time and increasing carbohydrate intake, antimicrobial prophylaxis and skin preparation), intraoperative management (prophylactic antibiotics before the CS, standard anaesthetic protocol, restrictive fluid administration, appropriate patient warming, skin closure with cosmetic sutures and multimodal analgesia) and postoperative care (restoration of gut function, nausea and vomiting prevention, postoperative patient-controlled analgesia, nutritional care, early skin to skin contact and breastfeeding, thromboembolism prophylaxis, early mobilisation, early urinary catheter removal and discharge counselling, etc).29

Type of control

The control group was given perioperative conventional care protocol. Conventional care adheres to traditional practices with less emphasis on interdisciplinary collaboration in the development of care plans. Preoperative phase typically follows customary practices without a specific focus on preoperative patient education, carbohydrate loading and avoidance of prolonged fasting. Intraoperative phase uses general or regional anaesthesia and conventional fluid administration (potentially leading to fluid overload), ignoring the opioid-sparing analgesia, maintenance of normothermia and early postoperative feeding. Postoperative care encompasses extended fasting periods, delayed mobilisation, prolonged use of opioids for pain management, and inadequate postpartum maternal and infant counselling.

Types of outcomes

The primary outcome will be the incidence of PPD, measured by validated EPDS. EPDS included 10 questions (range 0–3) with a total score ranging from 0 to 30, and scores of 10 or more were identified as potential PPD.30 Secondary outcomes will be the severity of PPD symptoms, PPD episodes, hospital stay, postoperative complications, breastfeeding rate and cost of hospitalisation.

Exclusion criteria

The exclusion criteria will be the following: (1) the literature data are incomplete or impossible to extrapolate; (2) duplicated publications and (3) research type involves editorials, letters, reviews, comments and case reports, etc.

Search strategy

A comprehensive search of the following databases (PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, China National Knowledge Infrastructure, Chinese Scientific Journal Database, Wanfang and Chinese Biomedical Literature Database) will be searched from their inception to July 2023. Furthermore, an additional search of the grey literature will be performed using Google Scholar, OpenGrey and PROQUEST Thesis& Dissertations. In addition, we will also search the reference lists of eligible studies to identify potential studies and the ongoing eligible trials in the international trial registry websites. The search strategy will be prepared and adapted for each database using appropriate truncation and combination of the keywords, MeSH Terms and entry Terms. The written language is limited to English or Chinese. The literature retrieval strategies are shown in table 1, with the PubMed database as an example.

Table 1

Search strategy in PubMed database

Selection of studies

Two researchers will independently screen and extract data based on the inclusion criteria and exclusion criteria. The disagreements will be resolved by group consensus. The searched literature will be imported into EndNote V.X8 (Thomson Reuters). First, the duplicates will be excluded initially. Second, reading the title and abstract to eliminate the irrelevant records. Finally, after reading the full text of the remaining records, the appropriate studies will be included. The entire process of screening is presented in figure 1.

Figure 1
Figure 1

Flow diagram of study selection process.

Data extraction and management

Two reviewers will extract data using a standardised extraction form, including the basic information of the included studies. The following information will be extracted: the first author, publication year, journal, study design, sample size, age, geographical population, experimental and control intervention, duration and follow-up, details of the risk of bias and outcomes. Any disagreements on data extraction will be resolved by discussion or reaching out to senior review author.

Assessment of risk of bias

Two independent reviewers will assess the risk of bias of the included RCTs according to the Cochrane Handbook,31 which included random sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, incomplete outcome data, selective reporting, and other sources of bias. Any disagreements between reviewers will be resolved by discussion or consultation with the third reviewer. Observational studies will be evaluated using the Newcastle-Ottawa Scale, which includes adequacy selection of cohort, comparability of studies and outcome assessment.

Assessment of heterogeneity and data synthesis

Statistical analyses will be calculated by the RevMan V.5.3 software and Stata V.13.0 (StataCorp). The dichotomous data will be performed as risk ratio, and continuous variables will be expressed as weighted mean differences or standard mean differences. All results will be performed with 95% CIs. Initial analyses will be assessed using the fixed-effects model regardless of heterogeneity. Heterogeneity will be tested by χ2 test and the I2 statistic (I2>50% indicates significant heterogeneity).32

Subgroup analysis and sensitivity analysis

Subgroup analysis will be performed to explore the potential heterogeneity and inconsistency based on the different characteristics of participants(eg, various age, race and gestation group; emergency or planned caesarean delivery). To test the robustness of the pooled results, the sensitivity analysis will be conducted by eliminating one study each time or excluding studies with low quality.

Publication bias

The potential publication bias will be evaluated using the funnel plots, Begg’s test and Egger’s test.33

Grading the quality of evidence

The quality of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation by two reviewers independently, which is classified as high, moderate, low or very low based on the study limitations, inconsistency, indirectness, imprecision and other factors.34

Discussion

Current treatment strategies for PPD mainly include antidepressants and non-pharmacological therapies.35 While antidepressants can alleviate symptoms of individuals experiencing PPD, many PPD patients are often reluctant to take it likely due to the concerns about breast milk transmission or potential side effects on their babies from antidepressants.36 Clinically, the application of non-pharmacological therapies was also far from satisfactory owing to the shortage of health professionals, slow therapeutic effect, time and financial constraints, etc.10 37 These barriers indicated the urgent need for meaningful and feasible approaches to prevent PPD, which intended to avoid the initial onset of PPD. Additionally, promising evidence has shown that preventive interventions were more acceptable than treatment for PPD.4

Here, we perceived that ERAS, an innovative evidence-based standardised protocol, may be an optional strategy for PPD prevention and can be employed in patients undergoing CS. However, the beneficial effects to PPD prevention arising from ERAS urgently need verification of high-quality evidence. Therefore, the present protocol plan to comprehensively integrate available evidence by rigorous procedure for exploring the potential use of ERAS as a prophylaxis for PPD. Specifically, we aim to evaluate the pooled effect of ERAS in decreasing the PPD incidence and alleviating PPD symptoms for CS patients, which provide researchers with important data regarding the absolute and relative efficacy. More importantly, we hope that relevant results will extend our understanding about ERAS in improving mental health, and provide clarity regarding the potential benefits and best practice of implementing ERAS in CS women for preventing PPD. Further investigation should develop the tailored ERAS protocol for PPD prevention with excellent protocol adherence.

Ethics and dissemination

Since this study is a meta-analysis based on existing researches, formal ethical approval is not required. The formal systematic review and meta-analysis is expected to be published in a professional journal.

Ethics statements

Patient consent for publication

This post was originally published on https://bmjopen.bmj.com