i-MoMCARE: Innovative Mobile Technology for Maternal and Child Health Care in Cambodia-study protocol of a cluster randomized controlled trial.

BACKGROUND: The Government of Cambodia established the village health support groups (VHSGs) in 2003 to facilitate primary healthcare activities, including maternal and child health (MCH) services. However, VHSGs face several challenges that hinder them from performing optimally, including a lack of regular structured training and remuneration and limited and inconsistent support and supervision from the health centers (HCs). This implementation research aims to develop, implement, and evaluate a digital health intervention to improve the performance of VHSGs through better support and supervision and increase the MCH service coverage in rural Cambodia. METHODS: i-MoMCARE, a two-arm cluster randomized controlled trial, will be conducted between 2022 and 2025. Five operational districts (ODs) have been randomized to an intervention arm and the other five ODs to the control arm. The intervention will last for 24 months. Around 200 VHSGs in the intervention arm will be equipped with a mobile application as a job aid and 20 HC staff with a web interface to improve support and supervision of VHSGs. The potential beneficiaries will include pregnant women, mothers, and children under 2 years old. We will measure the outcomes at baseline and endline. The primary outcomes will consist of a composite MCH index constructed from maternal and newborn care indicators, child immunization, and treatment of under-two children. Secondary outcomes will include coverage of selected MCH services. We will conduct the intention-to-treat and per-protocol analyses. We will conduct qualitative interviews with selected beneficiaries and stakeholders to evaluate the intervention's acceptability, feasibility, and scalability. We will also conduct a cost-effective analysis using decision-analytic modeling incorporating a societal perspective that explores different time horizons, intervention effects, and when scaled up to the national level. DISCUSSION: i-MoMCARE is expected to increase MCH service access and coverage in rural Cambodia. It will contribute to advancing digital health use in primary healthcare interventions, which remains in its infancy in the country. Furthermore, the study findings will be a valuable addition to a growing body of literature on the effectiveness and feasibility of mobile health to improve coverage of MCH services in rural low- and middle-income country settings. TRIAL REGISTRATION: ClinicalTrial.gov NCT05639595. Registered on 06 December 2022.

Stillbirth rates and their determinants in a national maternity hospital in Phnom Penh, Cambodia in 2017-2020: a cross-sectional assessment with a nested case-control study.

BACKGROUND: In Cambodia, stillbirths and their underlying factors have not been systematically studied. This study aimed to assess the proportion and trends in stillbirths between 2017 and 2020 in a large maternity referral hospital in the country and identify their key determinants to inform future prevention efforts. METHODS: This was a retrospective cross-sectional analysis with a nested case-control study of women giving birth at the National Maternal and Child Health Centre (NMCHC) in Phnom Penh, 2017-2020. We calculated percentages of singleton births at ≥ 22 weeks' gestation resulting in stillbirth and annual stillbirth rates by timing: intrapartum (fresh) or antepartum (macerated). Multivariable logistic regression was used to explore factors associated with stillbirth, where cases were all women who gave birth to a singleton stillborn baby in the 4-year period. One singleton live birth immediately following each case served as an unmatched control. Multiple imputation was used to handle missing data for gestational age. RESULTS: Between 2017 and 2020, 3.2% of singleton births ended in stillbirth (938/29,742). The stillbirth rate increased from 24.8 per 1000 births in 2017 to 38.1 per 1000 births in 2020, largely due to an increase in intrapartum stillbirth rates which rose from 18.8 to 27.4 per 1000 births in the same period. The case-control study included 938 cases (stillbirth) and 938 controls (livebirths). Factors independently associated with stillbirth were maternal age ≥ 35 years compared to < 20 years (aOR: 1.82, 95%CI: 1.39, 2.38), extreme (aOR: 3.29, 95%CI: 2.37, 4.55) or moderate (aOR: 2.45, 95%CI: 1.74, 3.46) prematurity compared with full term, and small-for-gestational age (SGA) (aOR: 2.32, 1.71, 3.14) compared to average size-for-age. Breech/transverse births had nearly four times greater odds of stillbirth (aOR: 3.84, 95%CI: 2.78, 5.29), while caesarean section reduced the odds by half compared with vaginal birth (aOR: 0.50, 95%CI: 0.39, 0.64). A history of abnormal vaginal discharge increased odds of stillbirth (aOR: 1.42, 95%CI: 1.11, 1.81) as did a history of stillbirth (aOR: 3.08, 95%CI: 1.5, 6.5). CONCLUSIONS: Stillbirth prevention in this maternity referral hospital in Cambodia requires strengthening preterm birth detection and management of SGA, intrapartum care, monitoring women with stillbirth history, management of breech births, and further investigation of high-risk referral cases.

In Cambodia, there is very little information published on stillbirths to know precisely how many there are and to understand the underlying reasons they occur so they can be prevented in the future. Our study aimed to quantify the number of stillborn babies and identify some underlying risk factors from one of the largest maternity referral hospitals in Phnom Penh, Cambodia. We examined data from almost 30,000 health facility medical files of women who gave birth between 2017 and 2020 which included 938 stillbirths. We found that about 3.2% of births ended in a stillbirth and that this percentage increased between 2017 and 2020. Women who had preterm babies, or whose babies were small in weight for their gestational age, and babies that were born breech had a higher chance of being stillborn. Women who had abnormal vaginal discharge, which can indicate a possible infection, also had a higher odds of having a stillbirth. We also found that women who had a stillbirth previously had almost three times higher chance of having another stillborn baby. Having a caesarean section reduced the likelihood of having a stillborn baby by about half. These findings suggest that efforts are needed to better identify and manage women with preterm births and monitor fetal growth as well as ensure breech births are managed adequately.

Validation of the person-centered maternity care scale at governmental health facilities in Cambodia.

BACKGROUND: Women's childbirth experience of interpersonal care is a significant aspect of quality of care. Due to the lack of a reliable Cambodian version of a measurement tool to assess person-centered maternity care, the present study aimed to adapt the "Person-Centered Maternity Care (PCMC) scale" to the Cambodian context and further determine its psychometric properties. METHODS: The PCMC scale was translated into Khmer using the team translation approach. The Khmer version of PCMC (Kh-PCMC) scale was pretested among 20 Cambodian postpartum women using cognitive interviewing. Subsequently, the Kh-PCMC scale was administered in a survey with 300 Cambodian postpartum women at two governmental health facilities. According to the COnsensus-based Standards for the Selection of health status Measurement Instruments (COSMIN) standard, we performed psychometric analysis, including content validity, construct validity, criterion validity, cross-cultural validity, and internal consistency. RESULTS: The preliminary processes of Kh-PCMC scale development including cognitive interviewing and expert review ensured appropriate levels of content validity and acceptable levels of cross-cultural validity of the Kh-PCMC scale with four-point frequency responses. The Scale-level Content Validity Index, Average (S-CVI/Avg) of 30-item Kh-PCMC scale was 0.96. Twenty items, however, performed optimally in the psychometric analysis from the data in Cambodia. The 20-item Kh-PCMC scale produced Cronbach's alpha of 0.86 for the full scale and 0.76-0.91 for the subscales, indicating adequately high internal consistency. Hypothesis testing found positive correlations between the 20-item Kh-PCMC scale and reference measures, which implies acceptable criterion validity. CONCLUSIONS: The present study produced the Kh-PCMC scale that enables women's childbirth experiences to be quantitatively measured. The Kh-PCMC scale can identify intrapartum needs from women's perspectives for quality improvement in Cambodia. However, dynamic changes in and diverse differences of cultural context over time across provinces in Cambodia require the Kh-PCMC scale to be regularly reexamined and, when needed, to be further adjusted.

Residual risk of mother-to-child transmission of HBV despite timely Hepatitis B vaccination: a major challenge to eliminate hepatitis B infection in Cambodia.

BACKGROUND: In countries with intermediate or high hepatitis B virus (HBV) endemicity, mother-to-child transmission (MTCT) represents the main route of chronic HBV infection. There is a paucity of information on HBV MTCT in Cambodia. This study aimed to investigate the prevalence of HBV infection among pregnant women and its MTCT rate in Siem Reap, Cambodia. METHODS: This longitudinal study included two parts, study-1 to screen HBsAg among pregnant women and study-2 to follow up babies of all HBsAg-positive and one-fourth of HBsAg-negative mothers at their delivery and six-month post-partum. Serum or dried blood spot (DBS) samples were collected to examine HBV sero-markers by chemiluminescent enzyme immunoassay (CLEIA), and molecular analyses were performed on HBsAg-positive samples. Structured questionnaires and medical records were used to examine the risk factors for HBV infection. MTCT rate was calculated by HBsAg positivity of 6-month-old babies born to HBsAg-positive mothers and ascertained by the homology of HBV genomes in mother-child pair at 6-month-old. RESULTS: A total of 1,565 pregnant women were screened, and HBsAg prevalence was 4.28% (67/1565). HBeAg positivity was 41.8% and was significantly associated with high viral load (p < 0.0001). Excluding subjects who dropped out due to restrictions during COVID-19, one out of 35 babies born to HBsAg-positive mothers tested positive for HBsAg at 6 months of age, despite receiving timely HepB birth dose and HBIG, followed by 3 doses of HepB vaccine. Hence the MTCT rate was 2.86%. The mother of the infected baby was positive for HBeAg and had a high HBV viral load (1.2 × 109 copies/mL). HBV genome analysis showed 100% homology between the mother and the child. CONCLUSIONS: Our findings illustrate the intermediate endemicity of HBV infection among pregnant women in Siem Reap, Cambodia. Despite full HepB vaccination, a residual risk of HBV MTCT was observed. This finding supports the recently updated guidelines for the prevention of HBV MTCT in 2021, which integrated screening and antiviral prophylaxis for pregnant women at risk of HBV MTCT. Furthermore, we strongly recommend the urgent implementation of these guidelines nationwide to effectively combat HBV in Cambodia.

Challenges and outcomes of implementing a national syphilis follow-up system for the elimination of congenital syphilis in Cambodia: a mixed-methods study.

OBJECTIVES: We aimed to describe the challenges and outcomes of implementing a national syphilis follow-up system to improve syphilis management in maternal and child health (MCH) services in Cambodia. DESIGN: Operational study; quantitative cohort data and cross sectional qualitative data. SETTING: Public health facilities at national level and in four provinces with high syphilis prevalence in Cambodia. PARTICIPANTS: Pregnant women screened for syphilis; MCH health care providers and managers. METHODS: We conducted an operational research using syphilis screening and treatment data collected from a national follow-up system (cohort data) and reported in the health management information system (HMIS) between 2019 and 2020. We also conducted indepth interviews with 16 pregnant women and focus group discussions with 37 healthcare providers and managers. Descriptive statistics and thematic content analysis were used. OUTCOME MEASURES: Syphilis testing and treatment results and perceptions regarding these services. RESULTS: A total of 470 pregnant women who tested positive in rapid syphilis testing were recorded in the national syphilis follow-up system in 2019-2020. Of these, 71% (332 of 470) received a rapid plasma reagin (RPR) test and 95% (n=315) tested positive; 78% (246 of 315) received any syphilis treatment and only 28% (88 of 315) were treated adequately with benzathine penicillin G (BPG). Data from four provinces with high syphilis prevalence (more closely monitored) showed higher testing and treatment rates than at the national level. HMIS aggregated data reported a higher number of pregnant women screened and treated for syphilis than the follow-up system during the same period. Barriers to syphilis testing and treatment included late antenatal care, long distance to RPR testing and treatment, partners' lack of support to reach the health facility, BPG stockout and poor adherence to oral treatment in the absence of BPG. Providers and managers reported a lack of communication across services, insufficient skills to treat infants and absence of clear guidance regarding the revised follow-up system. Study findings contributed to changes in operating procedures nationwide to facilitate access to syphilis testing and adequate treatment and a systematic follow-up of pregnant women and exposed infants. CONCLUSIONS: Study results contributed to informing improvements to syphilis management in MCH services in Cambodia.

Cultural adaptation of the person-centered maternity care scale at governmental health facilities in Cambodia.

BACKGROUND: In Cambodia, the importance of valuing women's childbirth experiences in improving quality of care has been understudied. This is largely because of absence of reliable Khmer tools for measuring women's intrapartum care experiences. Generally, cross-cultural development of those tools often involves translation from a source language into a target language. Yet, few earlier studies considered Cambodian cultural context. Thus, we developed the Cambodian version of the Person-Centered Maternity Care (PCMC) scale, by culturally adapting its original to Cambodian context for ensuring cultural equivalence and content validity. METHODS: Three rounds of cognitive interviewing with 20 early postpartum women were conducted at two governmental health facilities in Cambodia. Cognitive interviewing was composed of structured questionnaire pretesting and qualitative probing. The issues identified in the process of transcribing and translating audio-recorded cognitive interviews were iteratively discussed among study team members, and further analyzed. RESULTS: A total of 14 issues related to cultural adaptations were identified in the 31 translated questions for the Cambodian version of the PCMC scale. Our study identified three key findings: (i) discrepancies between the WHO recommendations on intrapartum care and Cambodian field realities; (ii) discrepancies in recognition on PCMC between national experts and local women; and (iii) challenges in correctly collecting and interpreting less-educated women's views on intrapartum care. CONCLUSION: Not only women's verbal data but also their non-verbal data and cultural contexts should be comprehensively counted, when reflecting Cambodian women's intrapartum practice realities in the translated version. This is the first study that attempted to develop the tool for measuring Cambodian women's experiences during childbirth, by addressing cross-cultural issues.

Immunoglobulin-free strategy to prevent HBV mother-to-child transmission in Cambodia (TA-PROHM): a single-arm, multicentre, phase 4 trial.

BACKGROUND: Prevention of mother-to-child transmission (MTCT) of hepatitis B virus (HBV) is based on administration of vaccine and immunoglobulins (HBIg) to newborns at birth and maternal antiviral prophylaxis for those with an HBV-DNA viral load of at 5·3 log10 IU/mL or more. Many low-income and middle-income countries face difficulty in accessing HBIg and HBV-DNA quantification. The aim of this study was to evaluate the effectiveness of an HBIg-free strategy to prevent MTCT of HBV. METHODS: TA-PROHM was a single-arm, multicentre, phase 4 trial done in five maternity units in Cambodia. Pregnant women who were positive for hepatitis B surface antigen (HBsAg), aged 18 years or older were included. Women who were HCV or HIV positive, had creatinine clearance of less than 30 mL/min, severe gravid disease, and planned to give birth outside the study sites were excluded. From Oct 4, 2017, to Jan 9, 2019, HBsAg positive pregnant women who tested positive for hepatitis B e antigen (HBeAg) with a rapid diagnostic test were eligible to receive tenofovir disoproxil fumarate. From Jan 9, 2019, women who were HBeAg negative with an alanine aminotransferase concentration of ≥40 IU/L were also eligible to receive tenofovir disoproxil fumarate. Women in the tenofovir disoproxil fumarate eligible group received 300 mg of tenofovir disoproxil fumarate orally once a day from the 24th week of gestation until 6 weeks postpartum. The primary outcome was the overall proportion of infants who were HBsAg positive at 6 months of life, confirmed by positive HBV DNA quantification. For the primary outcome, the proportion (95% CI) of infants with HBsAg at 6 months was stratified according to infant's HBIg status, duration of maternal tenofovir disoproxil fumarate treatment (>4 weeks and ≤4 weeks), and study period (before and after the change in therapeutic algorithm) and was measured in a modified intention-to-treat analysis, which excluded infants lost to follow-up or who were withdrawn before 6 months. The study is registered with ClinicalTrials.gov, NCT02937779. FINDINGS: From Oct 4, 2017, to Nov 27, 2020, 21 251 pregnant women were screened for HBsAg, of whom 1194 (6%) were enrolled in the study: 338 (28%) were eligible to receive tenofovir disoproxil fumarate. For the tenofovir disoproxil fumarate eligible group, four (1% [95% CI 0·34-3·20]) of 317 infants had HBV infection at 6 months; in the subgroup of 271 children who did not receive HBIg, four (1% [0·40-3·74]) had HBV infection at 6 months. In absence of HBIg, MTCT HBV transmission occurred in none (0% [0-1·61]) of 227 women who received tenofovir disoproxil fumarate for more than 4 weeks before giving birth and three (8% [1·75-22·47]) of 36 women who received tenofovir disoproxil fumarate for less than 4 weeks. In the tenofovir disoproxil fumarate ineligible group, seven (1% [0·40-2·02]) of 712 infants had HBV infection at 6 months; in the subgroup of 567 children who did not receive HBIg, six (1% [0·39-2·30]) had HBV infection at 6 months. INTERPRETATION: An immunoglobulin-free strategy using an HBeAg rapid diagnosis test and alanine aminotransferase-based algorithm to assess eligibility for tenofovir, is effective at preventing MTCT of HBV when tenofovir was initiated at least 4 weeks before birth. FUNDING: French Agency for Research on AIDS and Viral Hepatitis and Emerging Infectious diseases. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.