Assessing the maternal health-related digital health interventions for pregnant women and new mothers in developing countries: a protocol for a systematic review and meta-analysis

Abstract

Background

Maternal and child health remains a critical public health challenge in developing countries. Annually, an estimated 250 000–280 000 maternal deaths occur, with up to 95% attributed to inadequate access to timely, effective and quality healthcare. While digital health interventions have demonstrated significant potential in improving maternal health services, education and support in high-income settings, their effectiveness, feasibility and broader impact in resource-limited contexts remain understudied.

Methods and analysis

This systematic review will assess the effectiveness, feasibility and impact of digital health interventions for pregnant women and new mothers in resource-limited settings across developing countries. We will conduct a comprehensive search of MEDLINE (via PubMed), Embase, Scopus, Google Scholar and grey literature sources to identify randomised controlled trials, quasi-experimental studies and observational studies published in any language. The quality of included studies will be assessed using the Cochrane‘s risk of bias tools, RoB 2 for randomised trials and the ROBINS-I tool for non-randomised studies. A standardised data extraction form will be developed, piloted and used to systematically collect study data. We will employ the web-based CADIMA platform to facilitate screening, data extraction and evidence synthesis while minimising bias. Data will be synthesised narratively by summarising study characteristics and, where appropriate, through meta-analysis using random-effects models to calculate pooled effect sizes. Finally, we will evaluate the strength of the evidence for each outcome using the Grading of Recommendations Assessment, Development and Evaluation approach to assess confidence in the findings.

Ethics and dissemination

No ethical approval was required for this systematic review, as it uses only previously published data. The findings will be submitted for publication in a peer-reviewed journal and presented at relevant international conferences to disseminate them to the broader academic community. To ensure practical application of our results, we will develop a policy brief summarising key findings and recommendations.

PROSPERO registration number

This protocol is registered to PROSPERO, and the registration number is CRD42025631164.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This study analysed multiple study types by using the Cochrane Risk of Bias Tool 2 and ROBINS-I tools to minimise bias and ensure the reliability of the results.

• Employs the CADIMA tool for transparent study selection and reproducible analysis.

• The study screening and bias risk assessment will be conducted by five independent reviewers from multidisciplinary fields, reducing the risk of selection bias.

• Scarce high-quality studies and variable interventions across settings may limit findings.

Background

Maternal and child health remains a critical public health concern around the world, particularly in low- and middle-income countries (LMICs), where the burden of morbidity and mortality is disproportionately high due to multiple barriers to accessing healthcare services.^{1 2} About 250 000–280 000 women die during pregnancy and childbirth worldwide every year.³ Of the total maternal death cases, 95% occurred in developing countries. Children in developing countries are about 56 times more likely to die before the age of five compared with their counterparts in developed countries, which indicates a stark disparity in child survival and access to necessary healthcare services.⁴ Several studies have shown that maternal and child deaths are preventable through timely, evidence-based and cost-effective interventions. Women are regarded as being in a vulnerable state during pregnancy and the postpartum period due to the physiological and psychological changes they undergo.⁵ Recent research studies indicate that poor maternal health during the pregnancy and postpartum period can have detrimental consequences for both maternal and neonatal health outcomes, including increased risk of morbidity and mortality, which is a significant public health concern in LMICs.^{6 7} Despite substantial research addressing various aspects of maternal health—particularly initiatives aimed at improving childbirth outcomes with an emphasis on intrapartum care—relatively limited attention has been devoted to the design and implementation of interventions that support maternal health during pregnancy and the postpartum period in developing countries.^{8 9}

Several digital health interventions, such as telemedicine, telehealth and mHealth, demonstrated significant potential in enhancing access to maternal health services, education and psychosocial support around the world.^{10 11 12 13} However, the effectiveness, feasibility and impact of these interventions in resource-limited settings in LMICs need comprehensive evaluations. Against this backdrop, this systematic review and meta-analysis aims to synthesise and quantitatively analyse the existing evidence on the efficacy of these digital health interventions for pregnant women and new mothers in resource-limited settings of developing countries.

Objectives

Primary objective

This study aims to assess the effectiveness of telemedicine, telehealth and m-health interventions in improving maternal health outcomes among pregnant and postpartum women in developing countries.

Secondary objective

1. To characterise the types and modalities of digital health interventions deployed for maternal health support in resource-limited settings.

2. To assess the impact of these interventions on:

   • Healthcare access.

   • Utilisation of antenatal, delivery and postnatal services.

   • Health-seeking behaviours.

3. To explore the feasibility, acceptability and user satisfaction of these interventions among the target population and healthcare providers.

4. To conduct economic evaluations comparing cost-effectiveness between digital interventions and traditional care models.

5. To identify barriers and enabling factors to a successful implementation of maternal health-related digital interventions in developing countries.

6. To compare the effectiveness of different types of digital health interventions (telemedicine, telehealth and mHealth) in improving maternal health outcomes.

Research question

What is the comparative effectiveness of telemedicine, telehealth and mobile health (mHealth) interventions in improving (1) maternal morbidity/mortality, (2) service utilisation and (3) quality of care for pregnant and postpartum women in low-resource settings?

Methods and analysis

We used the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols checklist for reporting the protocol.¹⁴

Eligibility criteria

Study design

We will include randomised controlled trials, quasi-experimental studies and observational studies.¹⁵

This review will follow the PICO (P, Population; I, Intervention; C, Comparison; and O, Outcome) model to select the studies.

Population

Pregnant women and mothers up to 1 year postpartum in developing countries (as defined by the World Bank classification).

Intervention

Any telemedicine, telehealth or m-health intervention aimed at providing maternal health support, including but not limited to:

• Remote consultations and monitoring.

• Health education and behaviour change communication.

• Appointment reminders and scheduling.

• Emergency obstetric care support

• Postpartum care and support

• Maternal mental health support.

Comparators

Standard care, face-to-face interventions, other types of interventions or no intervention.

Outcomes

Primary outcomes

1. Clinical outcomes:

   • Maternal mortality ratio (per 100 000 live births).

   • Severe maternal morbidity (eg, eclampsia and postpartum haemorrhage).

   • Obstetric complication rates (including emergency interventions).

2. Service utilisation:

   • Facility-based delivery rates.

   • Antenatal care attendance (≥4 visits).

   • Postnatal care attendance within 48 hours.

Secondary outcomes

1. Behavioural and knowledge:

   • Maternal health knowledge scores.

   • Health-seeking behaviours (eg, timely complication recognition).

2. Implementation metrics

   • User satisfaction (patients/providers).

   • Intervention adherence rates.

   • Cost-effectiveness (incremental cost-effectiveness ratio per disability-adjusted life year averted).

3. Quality of life

   • WHOQOL-BREF scores (World Health Organization Quality-of-Life Scale).

   • Postpartum depression rates.

Literature searches

Electronic databases

• MEDLINE (via PubMed).

• Embase.

• Google Scholar

• Scopus.

Grey literature sources

• Preprint servers (medRixv).

• Thesis, dissertation or conference papers.

• Government reports.

• International Clinical Trials Registry Platform.

Other methods

To identify relevant research, we will also conduct a hand-search of the reference lists of included studies and relevant systematic reviews.

Search strategy

The strategy will be designed based on each of the databases. For example, a search strategy for PubMed is provided in online supplemental table 1.

Study records

Data management

For record management, studies that pass the selection criteria will be imported into EndNote. Additionally, the CADIMA tool will be used to ensure the transparency and reproducibility of the entire systematic review process.

Study selection

• Studies that meet the eligibility criteria will be further screened based on the availability of the abstract at the initial stage and then the full text.

• Five independent reviewers will screen titles and abstracts of identified studies for potential inclusion.

• Full texts of potentially eligible studies will be retrieved and independently assessed by five reviewers.

• Disagreements will be resolved through discussion or consultation with the fifth reviewer.

Risk of bias (quality) assessment

The quality of included studies will be assessed using appropriate tools based on study design:

• Cochrane Risk of Bias Tool 2 for randomised controlled trials.

• ROBINS-I V2 tool for non-randomised studies (experimental and observational studies).^{15 16}

Data extraction

A standardised data extraction form will be developed and piloted. Two reviewers will independently extract data from the included studies. The following information will be extracted:

• Study characteristics (author, year, country, study design and sample size).

• Population characteristics (age, gestational age, postpartum period and health conditions).

• Intervention details (type of digital intervention, duration, frequency and components).

• Comparison group details.

• Outcomes (maternal health outcomes, service utilisation, knowledge, behaviours, satisfaction, adherence and costs).

• Implementation factors (barriers, facilitators, feasibility and acceptability).

• Effect sizes and CIs.

• Information for assessment of the risk of bias.

Data synthesis

Narrative synthesis

For the narrative synthesis, the characteristics of the included studies will be summarised. The types of interventions and their components will be described. The overall direction and size of the effects for each outcome will be discussed.

Meta-analysis

For each outcome in the meta-analysis, we will calculate pooled effect sizes using random-effects models. Effect sizes will be expressed as risk ratios for dichotomous outcomes and mean differences or standardised mean differences for continuous outcomes, with 95% CIs. Heterogeneity will be assessed using the I² statistic and Cochran’s Q test. The strength of the body of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.

Analysis of subgroups or subsets

We will conduct subgroup analyses based on:

• Type of digital health intervention (telemedicine, telehealth and m-Health).

• Specific maternal health focus (eg, antenatal care, postnatal care and emergency obstetric care).

• Country income classification (low-income vs lower-middle-income).

• Study design (randomised controlled trial vs quasi-experimental).

• Urban versus rural settings.

Patient and public involvement

Patients or the public are not involved in the design, conduct, reporting or dissemination plans of our research.

Discussions

This systematic review will provide a comprehensive synthesis of the evidence on maternal health-related digital interventions for pregnant women and new mothers in developing countries. The findings will inform policymakers, healthcare providers and researchers about the effectiveness, feasibility and best practices of implementing these interventions in resource-limited settings. It will also highlight areas where further research is needed to support maternal health through digital interventions in developing countries.

Ethics and dissemination plans

The systematic review will use secondary data from existing literature and will not collect any personal or demographic data of study participants. However, ethical standards will be maintained when selecting studies and gathering secondary data, ensuring proper citations and acknowledgement of the authors.

The findings will be submitted for publication in a peer-reviewed journal and presented at relevant international conferences on maternal health, digital health, public health and global health to disseminate them to the broader academic community. To ensure practical application of our results, we will develop a policy brief summarising key findings and recommendations. This brief will be strategically disseminated to policymakers, non-governmental organisations and healthcare institutions working in maternal health across developing countries, facilitating evidence-based decision-making in resource-limited settings.