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A randomized controlled trial of dexamethasone 4, 5 and 6 milligrams to adverse neonatal and maternal outcomes in moderate to late preterm between 320-366 weeks of gestatio

Phase 2
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
Registration Number
TCTR20220511003
Lead Sponsor
Faculty of Medicine, Siriraj Hospital, Mahidol University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
Female
Target Recruitment
375
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
compare the effect of the drug 4, 5 and 6 mg dexamethasone for RDS in preterm infants 320-366 weeks gestation at 12 months end of the intervention More than 60 breaths per minute, flaring, grunting, retraction of chest, and oxygen for more than 2 hours postpartum.,compare the effect of the different doses of dexamethasone for adverse outcomes other than RDS in preterm infants 320-336 gestational age at 12 months end of the intervention adverse maternal and neonatal outcomes
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