Thai Baby Study Phase 1

March 23, 2026 updated by: Mead Johnson Nutrition

National Situational Analysis of Birth Mode and Infant Outcomes in Thailand

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

10300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Birth to 28 days of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Birth to 12 months of age
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.
Birth to 12 months of age
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.
2015 to 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Collaborators

Chulalongkorn University
Ministry of Health, Thailand

Investigators

  • Study Director: Veronica Fabrizio, DO, Mead Johnson Nutrition
  • Principal Investigator: Krit Pongpirul, MD, MPH, PhD, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 3399-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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