Investigator(s)
| Submitter |
Tshering Samdrup Ministry of Health Tshering Samdrup 
|
| Principal Investigator |
Kinley Dorjee Ministry of Health Kinley Dorjee
|
| Co-Investigator(s) |
Tshering Samdrup Ministry of Health Tshering Samdrup
|
| Co-Investigator(s) |
Tandin Dorji Ministry of Health Tandin Dorji
|
Title(s) and abstract
| Scientific title | Impact Evaluation of the Intelligent Cardiotocography (iCTG) Intervention on Maternal and Neonatal Outcomes in Bhutan |
| Public title | Impact Evaluation of the Intelligent Cardiotocography (iCTG) Intervention on Maternal and Neonatal Outcomes in Bhutan |
| Background | Despite substantial improvements in maternal and neonatal health indicators in Bhutan, preventable adverse perinatal outcomes persist, particularly in geographically remote areas with limited access to specialist obstetric services. Delayed detection of fetal distress contributes significantly to intrapartum stillbirths and early neonatal complications. To strengthen fetal monitoring at the primary care level, the Ministry of Health, in collaboration with the Japan International Cooperation Agency, introduced mobile intelligent cardiotocography (iCTG) devices across selected health facilities beginning in 2020, with further expansion in 2023. However, the impact of iCTG on perinatal outcomes has not been rigorously evaluated. |
| Objectives | To evaluate the implementation, utilization, and impact of iCTG on maternal and perinatal outcomes in Bhutan and generate policy-relevant evidence to inform national scale-up and sustainability. |
| Study Methods | A quasi-experimental study using a Difference-in-Differences (DiD) design will be conducted among 50 Primary Health Centres (PHCs), including 25 iCTG intervention facilities and 25 matched comparison facilities. Data will be pooled across six years (three pre- and three post-intervention years). The study population includes all pregnant women ≥26 weeks of gestation who received antenatal or intrapartum care at selected PHCs. The primary outcome is stillbirth or early neonatal death within 24 hours. Secondary outcomes include neonatal resuscitation, emergency cesarean section, and Apgar score < 7 at 5 minutes. Intention-to-treat (ITT) regression-based DiD models with PHC-clustered robust standard errors will be used to estimate the average treatment effect of iCTG availability. |
| Expected outcomes and use of results | The study is expected to determine whether the introduction of iCTG increases identification of high-risk pregnancies, improves timely referrals, and reduces adverse perinatal outcomes. With 25 clusters per arm and approximately 1,500 observations, the study is powered to detect a clinically meaningful reduction in adverse outcomes. |
| Keywords | iCTG, perinatal outcomes, fetal monitoring, Difference-in-Differences, digital health, primary health care. |
Research Details
| Student research | No |
| Start Date | 01-Feb-2026 |
| End Date | 31-Mar-2026 |
| Key Implementing Institution | Ministry of Health |
| Multi-country research | No |
| Nationwide research | Yes |
| Research Domain(s) | Maternal, Reproductive and Child Health |
| Research field(s) | Other (Maternal and Child Health) |
| Involves human subjects | Yes |
| Intervention Evaluation Research | |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | No |