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

Phase 3

Completed

• Conditions: rate of respiratory distress syndrome; late preterm, dexamethasone, respiratory distress syndrome, Apgar scores

• Registration Number: TCTR20201108003
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-01-31
• Study Start: 2020-11-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 194

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified