Thailand Birth and Infant Outcomes Study

NCT07498192 — Active not recruiting, 10300 participants, Mead Johnson Nutrition

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National Situational Analysis of Birth Mode and Infant Outcomes in Thailand

Registry	NCT07498192
Status	Active not recruiting
Study type	Observational
Enrollment	10300 (Estimated)
Sponsor	Mead Johnson Nutrition (Industry); collaborators: Chulalongkorn University, Ministry of Health, Thailand
Conditions	Outcome Assessment
Dates	start 2026-04-07, primary completion 2026-12-30 (estimated), completion 2027-03-30 (estimated), first posted 2026-03-27, last updated 2026-10-21
Locations	1 site in Thailand

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Cesarean Delivery Cohort			Mother-infant dyads in which delivery occurred by cesarean section. This observational cohort is identified retrospectively using routinely collected, de-identified national health data. No intervention is assigned.
Vaginal Delivery Cohort			Mother-infant dyads in which delivery occurred by vaginal birth. This observational cohort is identified retrospectively using routinely collected, de-identified national health data. No intervention is assigned.

+Outcome measures

Primary outcomes

Neonatal health outcomes associated with mode of delivery [Birth to 28 days of life]: 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.

Secondary outcomes

Early-life healthcare utilization during infancy [Birth to 12 months of age]: Frequency of healthcare utilization, including outpatient visits, emergency department visits, hospital admissions, and antibiotic use among infants by mode of delivery.
Breastfeeding outcomes by mode of delivery [Birth to 12 months of age]: Rates of exclusive and any breastfeeding among infants born by cesarean section compared with vaginal delivery, assessed using routinely collected health and nutrition records.
Temporal and geographic trends in cesarean delivery rates [Jan 2015 to Dec 2025]: Trends in cesarean section rates across regions, hospital levels, and time periods using national health administrative data.

+Eligibility

Sex: All, ages: any to 120 Years, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Records with missing or invalid delivery mode information.
* Records that cannot be reliably linked between mother and infant.

+Locations (1)

Facility	City	Country	Status
Chulaongkorn University	Bangkok	Thailand

+Investigators

Veronica Fabrizio, DO, Study director, Mead Johnson Nutrition
Krit Pongpirul, MD, MPH, PhD, Principal investigator, Chulalongkorn University