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The Effect of Antenatal Dexamethasone to Improve Respiratory Neonatal Outcomes in Late Preterm Birth :A Randomized Controlled Trial

The Effect of Antenatal Dexamethasone to Improve Respiratory Neonatal Outcomes in Late Preterm Birth :A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20201108003
Enrollment
Unknown
Registered
2020-11-08
Start date
2019-05-01
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

rate of respiratory distress syndrome late preterm&#44

Interventions

Dexamethasone 6 mg IM every 12 hours until delivery,NSS 1.5 ml IM every 12 hours until delivery
Active Comparator Drug,Placebo Comparator No treatment
Dexamethasone ,normal saline

Sponsors

none
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Criteria for inclusion in the study were women (a) had preterm labor defined as regular uterine contractions before 37 weeks accompanied by a change of cervical dilatation, effacement, or both, or initial presentation with regular contractions and cervical dilatation at least 2 cm (16) or (b) had spontaneous rupture of membranes (preterm PROM), diagnosed by pooling of fluid at posterior fornix with speculum examination, positive cough test and positive alkaline pH test or (c) had fetal or maternal indications for delivery between 34 and 36+6 weeks gestation, such as placenta previa or fetal growth restriction.

Exclusion criteria

Exclusion criteria: We excluded women with multiple gestations, those who had received a previous course of corticosteroids, infection or chorioamnionitis (fetal tachycardia>160 bpm, maternal fever > 37.8 °C and foul smelling amniotic fluid) during labor, overt diabetes mellitus, gestational diabetes mellitus, cervical dilation more than 5 centimeters, thrombocytopenia, allergy to corticosteroids, preeclampsia severe feature and HELP syndrome.

Design outcomes

Primary

MeasureTime frame
rate of neonatal respiratory distress syndrome 72 hours clinical signs and radiography

Secondary

MeasureTime frame
the need for CPAP, the NICU admission, Apgar score 1 and 5 min, TTN, IVH, adverse effects 7 days ventilator, blood sugar, clinical signs

Contacts

Public ContactPimon Kongprayoon

Department of Obstetrics and Gynecology, Queen Savang Vadhana Memorial Hospital, Chonburi, Thailand

Pimonkong@gmail.com0896666966

Outcome results

None listed

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