Coadaptation and implementation of intrapartum clinical guidelines to save lives during childbirth: Protocol for an adapted PartoMa intervention in Eastern Ethiopia

Abstract

Background

Although several clinical practice guidelines (CPGs) exist to improve maternity care, their relevance in low- and middle-income countries is often debated. Despite calls for local adaptation, gaps remain between CPG recommendations and on-the-ground realities, hampering their use. In Zanzibar, cocreated, context-specific PartoMa CPGs coupled with low-dose high-frequency training were associated with improved quality of intrapartum care and perinatal survival. In Ethiopia, where maternal and perinatal deaths remain high, we aim to adapt the PartoMa CPG from Tanzania to the context of thirteen government hospitals networked in the Ethiopian Obstetric Surveillance System (EthOSS) in the eastern region. In addition, we introduce the MOYO device into the CPGs to enable continuous monitoring of the fetal heart rate during childbirth.

Methods

This study has four phases: (I) a mixed-methods baseline situational analysis of current intrapartum practice and birth outcomes, clinical challenges and current CPG use; (II) cocreation of context-specific CPGs, which is based on (a) the Tanzanian PartoMa CPGs, (b) the situational analysis, and (c) focus group discussions with birth attendants, local health managers and women; (III) pilot implementation combined with a mixed-method evaluation of the adapted PartoMa intervention in two of the hospitals; and (IV) analysis of lessons learned from intercountry adaptation of the PartoMa intervention. The overall study design will be a quasi-experimental study with embedded qualitative analysis. Women with a positive fetal heart rate on admission will be evaluated for the quality of care provided and experienced birth outcomes. In addition, further analysis will be performed on the perceptions of birth attendants toward the use of interventions and other associated learning.

Discussion

The lessons learned from this cocreation of CPGs and implementation of other PartoMa interventions provide insight into how to adapt clinical decision support interventions between resource-constrained settings to enhance the competencies and quality of care provided by frontline health workers.

Trial registration number

The trial has been registered at ClinicalTrials.gov. Number of registration (NCT06273007). Date of registration: 15.02.2024.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12913-026-14228-4.

Introduction

Despite an increase in facility births in Ethiopia from 10% in 2011 to 48% in 2019, more than 10,000 women die every year during pregnancy, childbirth, or within 42 days of childbirth [1, 2]. Furthermore, 24.6 stillbirths and 26.5 early neonatal deaths occur per 1,000 total births each year [3–5]. Notably, intra-facility mortality accounts for a major burden, and the readiness of the healthcare system to provide high-quality care is insufficient to match the rapid growth in facility births [6]. Such readiness is troubled by a lack of human and financial resources, and insufficient pre- and in-service training hampers clinical skills among the too few available staff [7, 8].

Several global and international clinical practice guidelines (CPGs) have been developed to reduce severe maternal outcomes (SMOs) and perinatal deaths and ensure a positive childbirth experience [9, 10]. However, their applicability in the local context of low- and middle-income countries (LMICs) remains controversial, as these global CPGs are often misaligned with on-the-ground realities [11, 12]. This situation forces healthcare providers to navigate CPGs that do not reflect their available resources and skills. In addition, CPGs may not consider the needs and preferences of women in a particular context [13]. Moreover, some CPGs may over divert limited resources from other health priorities, leaving crucial operational gaps [11, 14, 15].

While CPGs at times undergo some level of adaptation at the national level in LMICs, most are merely adopted [16]. In particular, the national adaptations in CPGs often overlook the perspectives and expertise of frontline health workers and the patients they treat. Furthermore, most CPGs are implemented without proper pilot testing or post-implementation evaluation in local contexts [11, 17]. As the PartoMa team previously unfolded: “while medications have to pass through multiple phases of trials before approval as well as post-approval monitoring, CPGs are often disseminated without any pilot testing or post-implementation testing of effects and side effects” [11, 18]. Such a lack-of-fit in CPG development is argued to be a central cause of the dangerous co-existence of ‘too little too late’ and ‘too much too soon’ maternity care in low-resource settings, with stark disparities in care provision [19]. This co-existence is characterized by late intervention in some births and overmedicalization in others [20]. For instance, while less invasive options during labor -such as vacuum extraction- are the safer options, caesarean sections are now often resorted to in the second stage, which is an alarming sign of ‘too much too soon’, exposing women and infants to unnecessary risks [21].

Furthermore, this one-directional top-down approach in CPG development with a mismatch between ideal care, as presented in CPGs, and actual local realities may discourage health staff, contributing to frustration among already over-burdened staff and undermining the uptake of CPGs [22, 23]. Consequently, healthcare workers often default to non-evidence based personal and collective judgment, resulting in inconsistent care and suboptimal outcomes [24].

In countries with very high maternal and perinatal mortality rates, it is essential to support birth attendants in providing evidence-based and respectful care, depending on women’s care needs and available resources [25]. Co-created context-specific guidelines were initiated in Zanzibar in 2014 and in Dar es Salaam in 2022 as part of the PartoMa program. The overall aim of the PartoMa cocreation is to establish achievable and acceptable integrated CPGs for healthcare providers, which will assist them in delivering the best possible, evidence-based, and respectful care during childbirth. The PartoMa approach demonstrated how cocreated context-specific CPGs coupled with low-dose, high-frequency training were linked to notable improvements in care quality and perinatal survival [23, 26]. It also highlights the need for significant modifications of internationally recognized CPGs to meet the local context [22]. This study aimed to improve the quality of childbirth in eastern Ethiopia by coadapting the PartoMa approach, which consists of cocreated CPGs and low-dose high-frequency training in 13 public hospitals.

Our specific objectives are as follows:

• I.To conduct a mixed-method situational analysis of current clinical practices and birth outcomes in maternity care in eastern Ethiopia
• II.To cocreate context-specific PartoMa-Ethiopia CPGs and training (PartoMa-Approach)
• III.To pilot this adapted PartoMa intervention in an Ethiopian context;
• IV.To learn and describe the lessons learned from this intercountry adaptation.

Methods

Study organization and setting

The study is based on a collaboration between Haramaya University, Ethiopia; the PartoMa Tanzania research group at Aga Khan University, Dar es Salaam, Tanzania; the University of Copenhagen in Denmark; and Leiden University Medical Center in the Netherlands.

This study will be conducted in 13 hospitals under the Ethiopian Obstetric Surveillance System (EthOSS) in eastern Ethiopia. These facilities, ranging from a primary hospital to a tertiary academic hospital, provide comprehensive maternity care, including cesarean section and blood transfusion. According to monthly reports, the average number of women who give birth in these hospitals ranges from 200 to 700. The overall characteristics of hospitals networked under EthOSS and the details of the EthOSS methodology are described elsewhere [27].

Following baseline assessment and cocreation, implementation will be piloted in two of the 13 hospitals, Haramaya General Hospital and Hiwot Fana University Hospital, before scaling up to the remaining hospitals. As these hospitals are the largest in charge of training the next generation and are highly influential in creating change in clinical practice at lower-level facilities, this pilot will generate valuable insights to inform a strategic and evidence-based scale-up to the other 11 hospitals. Hiwot Fana University Hospital is the only tertiary hospital in the region, serving a population of 20 million and assisting 5,000 births annually. The obstetrics, gynecology, and neonatal units were run by 49 midwives, 30 residents of obstetrics/gynecology, 22 consultant obstetricians, 16 pediatricians, and 14 neonatal nurses. Haramaya General Hospital, located 20 km from Hiwot Fana University Hospital, has 5,000 births annually. The obstetrics and gynecology and neonatal units were run by 35 nurse-midwives, six neonatal nurses, two pediatricians, three integrated emergency and surgical officers (IESO), one obstetrician and one general practitioner [28].

PartoMa intervention and related program theory

The aim of the PartoMa intervention was to improve maternity care by identifying context-adapted solutions for resource-limited settings by cocreating related CPGs. It consists of cocreated, evidence-based CPGs tailored to fit the realities of low-resource settings while maintaining essential emergency obstetric and newborn care, as well as the WHO partograph [22, 29]. Any modifications to CPGs deviating from existing global recommendations are based on careful systematic contextualization, assessment of the latest scientific literature, and peer review by an external, international board of specialists.

In line with PartoMa in Tanzania, we aim for the PartoMa-Ethiopia intervention to employ CPGs and low-dose, high-frequency training sessions in the workplace, where health providers will receive hands-on skills and drill training on selected topics derived from local case scenarios. When cocreated in close collaboration with end-users, the intervention ensures a user-centered design and a level of adaptability on the basis of changing contextual realities. The goal of the cocreation is to have locally suited, simple, and realistic CPGs for maternity care that will be implemented and used by frontline workers to enhance timely, evidence-based, and respectful care. Furthermore, we introduce the MOYO device for continuous monitoring of fetal heart rate [30].

As the study aims to increase survival during birth by increasing knowledge and skills through the cocreation of CPGs and training, this intervention takes the form of a complex and multifaceted approach. Lessons from the previous PartoMa study revealed nonlinear interactions between behavioral, biomedical and structural elements [31, 32]. Birth attendants are cocreators, implementers and end-users of the intervention, which adds complexity to the study design and outcomes.

To explore this complexity, we also build on the existing program theory of change that was developed for the recent Tanzanian PartoMa birth study in Dar es Salaam [33, 34]. The decision to retain the original program theory ensures theoretical continuity while allowing for an expanded understanding of its impact, given the combination of supplementary strategies, including fetal monitoring via MOYO, in Ethiopian intervention [35]. Our approach enables a rigorous assessment of how additional components interact with established interventions, offering new insights into the scalability and sustainability of previous PartoMa interventions in Zanzibar and Dar es Salaam [33, 34].

The overall study design will be a quasi-experimental study with embedded qualitative analysis. In line with this programme theory of change, a comprehensive mixed-method study design will be employed, and the theory will undergo further adaptation and refinement based on findings from the initial situational analysis. In this study, a register-based assessment of the situational analysis will be performed in all 13 facilities under EthOSS. However, direct clinical observations in the situational analysis, overall cocreation process, and pilot testing will be conducted at Hiwot Fana University Hospital and Haramaya General Hospital. The overall phase of the PartoMa-Ethiopia study is shown in Fig. 1. The PartoMa Ethiopia research team includes obstetricians, senior midwives, PhD students and experts in research methodologies and implementation sciences, who are responsible for overseeing the overall methodologies of the PartoMa study’s alignment with local and national guidelines.

Fig. 1.

Phases of the PartoMa-Ethiopia study, adapted from Housseine et al., 2025 [36]

Phase 1: Situational analysis

To understand the context, barriers, and opportunities for the successful implementation of the planned intervention, a mixed-method situational analysis will be conducted. Quantitative data will be collected from the 13 hospitals under the EthOSS to determine the burden of primary (intrahospital stillborn) and secondary outcomes (low Apgar scores, admission to the neonatal intensive care unit, cesarean section rate, partograph use, and maternal deaths). This will be accomplished through a review of medical records, in-depth interviews and focus group discussions (FGDs) with birth attendants, women who gave birth, and hospital administrators. This will enable exploration of the experiences of study participants with care provisions, with a focus on exploring the process of decision-making during childbirth, perceptions of quality of care and challenges and opportunities related to current clinical decision support during childbirth (including CPGs).

To assess the structural organization (women’s load and availability of resources) and possible sensitive topics that might be difficult to discuss during interviews, direct observations will be conducted during care provision by trained research assistants via structured checklists in the two pilot hospitals. Following the situational analysis, we present findings to birth attendants and hospital administrators to arrive at a common understanding of the situation in intrapartum care practices.

Phase 2: Intervention: coadaptation of context-specific CPGs for childbirth (cocreation process)

Recruitment of participants and the cocreation process

Using the PartoMa interventions from Dar es Salaam, including the CPG and training materials, we will codesign PartoMa Ethiopia [33]. Insights from all stakeholders (birth attendants, women who gave birth, hospital administrators, professional associations and local health authorities) will be included in the cocreation process. During workshops, birth attendants will thoroughly review the PartoMa CPG from Dar es Salaam to contextualize to their specific setting by comparing it with (inter)national guidelines and hospital protocols. FGDs will be conducted with birth attendants to explore collective behavior and norms related to intrapartum care and decision making. With the aim of creating equal opportunities for all birth attendants to share their opinions and experiences, the cocreation workshop will be held separately for midwives and obstetricians.

Findings and experiences from previous cocreation groups will be discussed in the subsequent section. The iterative cycles of cocreation among birth attendants continue until all groups reach consensus regarding CPG content. For the external review of the CPGs, the final product of the cocreation workshop with all birth attendants will be shared with representatives from hospital administrators, professional associations and local health authorities. In addition, reviews will be sought from an international board of experts [37]. The overall cocreation process is illustrated in Fig. 2.

Fig. 2.

Cocreation process of the PartoMa-Ethiopia clinical practice guidelines, 2025

Additionally, other PartoMa interventions (training and seminar sessions), including content, frequency, timing, mode of conductance, facilitation and venue, will be co-decided with birth attendants.

Evaluation of the cocreation process

Cocreation involves a broader methodology, emphasizing collective creativity and collaboration among cocreators in all cocreation cycles with built-in flexibility to accommodate changes in the context [38, 39]. A participatory approach embedded with qualitative exploration will be used to evaluate the overall process of cocreation [34, 37, 40, 41]. In-depth interviews and FGDs will be held after each workshop to explore participants’ perspectives on the cocreation process, with particular attention to aspects they felt were effective and those that could be improved.

During each cycle of cocreation, the overall cocreation process (workshop activities, participation and interaction between cocreators) will be assessed through participatory observation.

Phase 3: Pilot-implementation and evaluation interventions

Once cocreation of the CPG and training materials is completed, the locally drafted PartoMa-Ethiopia pocket CPG will be printed and given to all birth attendants for use in the two pilot hospitals. We will ensure the availability of MOYO devices for monitoring the fetal heart rate and identifying abnormalities as part of the intervention. We also received 28 MamaBirthie CS manikins from Laerdal Global as part of the BOGO (buy one gives one) initiative, which we will use for clinical skills training. Using the topics from the PartoMa pocket CPG, we introduce a series of quarterly, low-dose, high-frequency training sessions based on real clinical scenarios of selected obstetric conditions from these settings. To ensure the participation of all birth attendants, training schedules are arranged considering work shifts at convenient times. During training sessions, trainees will be provided with training materials and refreshments. Notably, the cocreation plan may, however, lead to changes in this tentative outline.

Evaluation of changes after interventions

In accordance with Kirkpatrick’s model for assessing the effects of training interventions, evaluation will be done at four levels: (i) healthcare providers’ perceptions and reactions, (ii) their potential learning, iv) potential changes in care provision, and iv) birth outcomes [42].

Birth attendants’ “perceptions and reactions” about the pocket CPG, training and other parts of the interventions (e.g., the MOYO device) will be assessed through open-ended questions and interviews (Kirkpatrick I). Potential changes in learning during training will be assessed by pretesting a tool used thus far to assess retention of knowledge and skills after training in emergency obstetric care [43]. At Kirkpatrick level II, paired knowledge and skills tests will be conducted during each pre- and post-seminar event [44].

Potential behavioral changes in clinical practice will be assessed using non-participatory observation for compliance with using the PartoMa pocket CPG, improved safe and respectful maternity care, improved monitoring of women during labor, ability to detect FHR and labor progress abnormalities, and improved timely decision making (Kirkpatrick III). In this case, the researchers will try to minimize Hawthorne’s effect by blinding study indicators and explaining that the aim of observation is to improve the quality of care. In addition, case files will be audited to check for changes in the completeness of partographs and other pertinent indicators, such as intrahospital stillbirths, low Apgar scores, NICU admission, and the rate of cesarean section (Kirkpatrick IV). After 12 months of implementation, a comparison will be made between findings from the situational analysis and those from the postintervention implementation to assess changes in primary outcomes (intrahospital stillbirth) and secondary outcomes (low Apgar scores, admission to the neonatal intensive care unit, cesarean section rate, and maternal deaths). To avoid seasonal variation for both baseline and postimplementation, the comparison will be made in identical months. Furthermore, adherence to intrapartum care guidelines and women’s care experiences will be assessed via in-depth interviews [45–48].

Phase 4: Lessons learned from intercountry CPG adaptation

The adaptation of CPGs across countries involves a comprehensive secondary thematic analysis of the two countries’ multi-method sub studies, as well as in-depth interviews with primary researchers from both countries.

Eligibility criteria

To assess changes in primary and secondary outcomes, only laboring women with positive fetal heart beats at admission will be included in this study.

Power calculation

The power calculation is based on a two-sided comparison of two independent proportions for primary outcome (still birth rate before and after implementation of the PartoMa interventions). According to our finding from baseline data the rate of intrahospital stillbirth among women admitted with a positive FHR on admission was 21.5 per 1000 total births. With an expected 40% reduction in-hospital stillbirths by the PartoMa interventions, the sample size of 3820 births at both pre and post intervention implementation is required at a 95% confidence interval to achieve 80% power.

Data collection technique and quality

Data will be collected by trained research assistants via a semi-structured tool prepared through a literature review [47, 49, 50]. For the quantitative study, a data collection tool containing pertinent information on sociodemographic status, obstetric characteristics, intrapartum care, and birth outcomes will be used [50, 51]. Data will be collected from maternal charts after the tool is piloted. Since the quantitative data in this study relies on routinely collected data, an attempt will be made to keep the completeness of the data for outcomes and key denominators at both phases. For the outcome data, if there were time points where data will be missing, those data points will be excluded from the analysis for that specific outcome but will be kept for other considerable analysis.

Training will be given to the data collectors on the objectives of the study, the content of the data collection tools and ethical considerations. Trained research assistants will conduct participant observation. The interviews and FGDs will be conducted by researchers fluent in local languages (Afan Oromo and Amharic).

Data analysis

The overall analysis of data from the situational analysis, cocreation process, and post-intervention implementation will be performed via multiple approaches. For the quantitative data, descriptive and inferential statistical analyses will be performed by STATA 16.0. Descriptive statistics, such as the means (SDs) and medians (IQRs), and normal frequency distributions across most variables will be calculated. For a comparison of primary and secondary outcomes before and after implementation of the intervention, multivariable regression (poison with robust standard errors or logistic regression) will be used to adjust for the confounders. Adjusted prevalences, risk differences, and prevalence ratios along with 95% confidence interval will be estimated using marginal standardization. For unadjusted comparison, a two-sample test of proportions or Fisher’s exact test will also be conducted. Firth penalized logistic regression analysis will be done for rare events. Moreover, the change in birth attendant knowledge after receiving training will be analyzed via paired t tests or Wilcoxon signed-rank tests. Data from the qualitative will be analyzed via a thematic analysis approach. Records from the interviews and FGDs will be transcribed and translated into English. To become acquainted with the depth and content of the data, the transcripts will be checked several times before being exported into ATLAS.ti 25 software for coding. The codes will be condensed into sub-theme headings based on shared concepts. Based on their importance, the identified subthemes will be examined, refined, divided, or combined. Finally, themes will be identified, and the write-up will be performed by connecting memos with quotations. Standards for Reporting Qualitative Research will be used to assist a report from the findings [52].

Ethical approval and consent to participate

The PartoMa-Ethiopia study has been reviewed and approved by the Institutional Health Research Ethics Review Committee of the College of Health and Medical Sciences, Haramaya University, Ethiopia (Ref. No: IHRERC/087/2023). The study will be conducted in accordance with the Helsinki Declaration for research involving human participants [53]. The study is also registered at ClinicalTrials.gov (NCT0627300). Written and Informed consent will be obtained from the medical directors, heads of maternity units, from participating women and birth attendants. All collected data will be anonymized. Key findings will be shared with hospital managers, stakeholders, frontline healthcare providers, participating women and community representatives anonymously.

Discussion

While developing clinical guidelines is a common practice by (inter)national organizations or professional societies, the quest continues for CPGs that reflect local realities and empower birth attendants to make optimal clinical decisions [11]. Nonrealistic clinical guidelines might lead to either no use of CPGs or unforeseen adjustments to care, resulting in variable and sometimes risky care provisions. Studies have suggested that straightforward and easily understandable CPGs are more likely to be implemented [54, 55].

The Zanzibar PartoMa experience had positive effects on context-specific intrapartum care CPGs. This was likely accomplished by prioritizing local relevance and evidence, eliminating variability in practice, encouraging shared decision-making and committing to ongoing updates. These efforts may contribute to a more responsive and effective healthcare environment that fulfills the requirements of women under various circumstances [22, 26]. On the basis of experience from Tanzania, PartoMa-Ethiopia focuses on a review of existing guidelines to contextualize local suits and their use for decision-making. Moreover, lessons learned during cocreation will provide insight into what enhances competencies, motivation, and clinical care among frontline healthcare workers in Ethiopia and other similar settings.

By including frontline birth attendants from inception to the completion of the CPG development process, the development of training, and their implementation, a sense of local ownership will arise. The cocreation approach involves a variety of additional stakeholders ranging from women to hospital administrators and local health authorities. The aim is to ensure the broad relevance and acceptance of context-specific CPGs. This cocreation of context-specific intrapartum care CPGs is the first of its kind in Ethiopia and may serve as a foundation for future cocreation projects within and beyond maternity care. While cocreation offers significant opportunities to improve healthcare systems, it also presents several dilemmas, such as balancing diverse perspectives, addressing potential conflicts of interest, and ensuring equitable representation among cocreators. This requires a strategic approach that addresses the tensions between cocreators by fostering flexibility, opening communication, and implementing structured processes [56, 57]. In addition, participation in low-dose, high-frequency PartoMa-Ethiopia seminars and adherence to pocket-CPGs may be influenced by individual motivation, which could limit their effectiveness.

Supplementary Information

Below is the link to the electronic supplementary material.

Abbreviations

BOGO

Buy One Give One

CPG

Clinical Practice Guideline

EthOSS

Ethiopian Obstetric Surveillance System

FGD

Focus Group Discussion

IQR

Inter Quartile Range

LMIC

Low- and Middle-Income Countries

SD

Standard Deviation

SMO

Severe Maternal Outcomes

Author contributions

H.B., N.M., N.H., J.v.R., T.vd.A., and A.K.T. conceived the study. H.B. drafted the manuscript under the supervision of A.K.T., T.vd.A., N.H., N.M. and J.v.R. Finally R.A., S.G., R.A.M., E.J., H.W., N.M., A.K.T., and T.vd.A, critically reviewed the methodological draft of the manuscript for intellectual content. All the authors reviewed the final manuscript and approved its submission.

Funding

This study is funded by the Laerdal Foundation for HB (ref no: 2023 − 0263) and AKT (ref no: 2022 − 0256). The funding body had no role in the study design, data collection, analysis, or interpretation.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to participate

The study will be conducted in accordance with the Helsinki Declaration for research involving human participants, and ethical approval was granted by the Institutional Health Research Ethics Review Committee (IHRERC) of Haramaya University (Ref. No.: IHRERC/087/2023). All the participating hospitals approved the study. Informed consent will be obtained from the head of all participating hospitals.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.