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NCT Number: NCT07498192

Thai Baby Study Phase 1

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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Key information

Conditions

Outcome Assessment

Age range

Up to 120 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Neonatal health outcomes associated with mode of delivery

    Time frame: 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

  1. Early-life healthcare utilization during infancy

    Time frame: 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.

  2. Breastfeeding outcomes by mode of delivery

    Time frame: 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.

  3. Temporal and geographic trends in cesarean delivery rates

    Time frame: 2015 to 2025

    Trends in cesarean section rates across regions, hospital levels, and time periods using national health administrative data.

Study contacts

Contact information is provided by the study sponsor or research team.

Amber Jessell

CONTACT

[email protected]

812-429-8903

Jami Walker, MSc

CONTACT

[email protected]

812-429-7299

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Collaborators

  • Chulalongkorn University
  • Ministry of Health, Thailand

Registry information

Official study title

National Situational Analysis of Birth Mode and Infant Outcomes in Thailand

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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