Thai Baby Study Phase 1
ConditionOutcome Assessment
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 120
SponsorMead Johnson Nutrition
About this trial
The goal of this observational study is to examine national trends in mode of delivery and to assess associations between cesarean section and early-life health outcomes using routinely collected health data in Thailand. The study includes mother-infant dyads delivering in public hospitals across Thailand.
The main questions it aims to answer are:
Is cesarean delivery associated with increased risk of adverse neonatal outcomes compared with vaginal delivery?
Is cesarean delivery associated with differences in early-life healthcare utilization and breastfeeding outcomes during the first year of life?
Researchers will compare infants born by cesarean section with infants born by vaginal delivery to evaluate differences in neonatal morbidity, healthcare utilization, and breastfeeding patterns.
Participants will not receive any intervention. The study involves secondary analysis of de-identified national health administrative and clinical data, including delivery records and linked maternal and infant health outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mother-infant dyads with delivery records available in the national health administrative database.
Deliveries occurring in public hospitals in Thailand during the study period.
Records containing information on mode of delivery and linked maternal and infant outcomes.
Disqualifiers
Records with missing or invalid delivery mode information.
Records that cannot be reliably linked between mother and infant.
Trial population
This study includes mother-infant dyads identified retrospectively from routinely collected, de-identified national health administrative and clinical data from public hospitals in Thailand.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
10,300 Participants
are grouped into 2 trial groupsGroup A: Cesarean Delivery Cohort
Group B: Vaginal Delivery Cohort
Trial outcomes
Primary outcomes
1
Neonatal health outcomes associated with mode of delivery
Comparison of neonatal health outcomes, including birth asphyxia, neonatal infection, respiratory complications, and low birth weight, between infants born by cesarean section and vaginal delivery using routinely collected national health data.
Time frame
Birth to 28 days of lifeSecondary outcomes
1
Early-life healthcare utilization during infancy
Frequency of healthcare utilization, including outpatient visits, emergency department visits, hospital admissions, and antibiotic use among infants by mode of delivery.
Time frame
Birth to 12 months of age2
Breastfeeding outcomes by mode of delivery
Rates of exclusive and any breastfeeding among infants born by cesarean section compared with vaginal delivery, assessed using routinely collected health and nutrition records.
Time frame
Birth to 12 months of age3
Temporal and geographic trends in cesarean delivery rates
Trends in cesarean section rates across regions, hospital levels, and time periods using national health administrative data.
Time frame
2015 to 2025Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mead Johnson Nutrition
Lead sponsor
Chulalongkorn University
Collaborator
Ministry of Health, Thailand
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: