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Double blind, non-inferiority, randomized controlled trial of dexamethasone 4, 5 and 6 milligrams to adverse neonatal and maternal outcomes in very preterm to late preterm between 290-366 weeks of gestation

Double blind, non-inferiority, randomized controlled trial of dexamethasone 4, 5 and 6 milligrams to adverse neonatal and maternal outcomes in very preterm to late preterm between 290-366 weeks of gestation

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220511003
Enrollment
375
Registered
2022-05-11
Start date
2023-05-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dexamethasone 4 mg ,5 mg and 6 mg, adverse neonatal and maternal outcomes dexamthasone, 4mg, 5 mg, 6 mg, adverse outcome, maternal outcomes, neonatal outcomes

Interventions

Dexamthasone 5 mg will be administrated in pregnant women 320-366 weeks of gestation.,Dexamthasone 4 mg will be administrated in pregnant women 320-366 weeks of gestation.,Dexamthasone 6 mg will be ad
Dexamethasone 5 mg,Dexamethasone 4 mg,Dexamethasone 6 mg

Sponsors

Faculty of Medicine, Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women who gave birth in the gestational age of 320-366 weeks by calculating the gestational age from the menstrual history and ultrasound during the first trimester. 2. Singleton pregnancy 3. Pregnant women with preterm labor 4. Pregnant women who signed their consent to participate in the research

Exclusion criteria

Exclusion criteria: 1. Pregnant women under 18 years of age 2. Pregnant women who have received steroids before 32 weeks of gestation 3. Pregnant women with steroid allergy or have an infection 4. Pregnant women with gestational diabetes include gestational diabetes mellitus and pregestational diabetes mellitus.

Design outcomes

Primary

MeasureTime frame
RDS in preterm infants 320-366 weeks gestation at 12 months after end of the intervention More than 60 breaths per minute, flaring, grunting, retraction of chest, and oxygen for more than 2 hours postpartum.

Secondary

MeasureTime frame
adverse maternal outcomes at 30 days after intervention maternal fever, maternal infection,adverse neonatal outcomes at 30 days after intervention neonatal fever, neonatal hypotension,respiratory complications except RDS

Countries

Thailand

Contacts

Public ContactSaifon Chawanpaiboon

Faculty of Medicine, Siriraj Hospital, Mahidol University

saifon.cha@mahidol.ac.th024197000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026