Outcome AssessmentNCT07498192
Thailand Birth and Infant Outcomes Study
An observational study of Outcome Assessment, run by Mead Johnson Nutrition at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Outcome Assessment
- How many people
- 10,300 participants
- Where
- 1 siteThailand
- Study dates
- 7 Apr 2026to 30 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Records with missing or invalid delivery mode information.
- Records that cannot be reliably linked between mother and infant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
- Conditions
- Outcome Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Birth to 28 days of life
Secondary outcomes (3)
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.
Measured: Birth to 12 months of age
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.
Measured: Birth to 12 months of age
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.
Measured: Jan 2015 to Dec 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start7 Apr 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcome AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chulalongkorn University, Ministry of Health, Thailand
- Responsible party
- Sponsor
- Investigators
- Veronica Fabrizio, DO, Study director, Mead Johnson NutritionKrit Pongpirul, MD, MPH, PhD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498192
- Sponsor's protocol ID
- 3399-1
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Situational Analysis of Birth Mode and Infant Outcomes in Thailand
- ClinicalTrials.gov ID
- NCT07498192
- Acronym / sponsor ID
- 3399-1
- Conditions
- Outcome Assessment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,300 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Chulalongkorn University, Ministry of Health, Thailand
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Records with missing or invalid delivery mode information.
- Records that cannot be reliably linked between mother and infant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Early-life healthcare utilization during infancy
Time frame: Birth to 12 months of age
Breastfeeding outcomes by mode of delivery
Time frame: Birth to 12 months of age
Temporal and geographic trends in cesarean delivery rates
Time frame: Jan 2015 to Dec 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Fabrizio, DO study director
Mead Johnson Nutrition
Krit Pongpirul, MD, MPH, PhD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcome Assessment, run by Mead Johnson Nutrition at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal health outcomes associated with mode of delivery (time frame: Birth to 28 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.