NCT04407975

Effect of Single Dose Antenatal Betamethasone on Neonatal Respiratory Morbidity After Elective Cesarean

Effect of Single Dose Antenatal Betamethasone on the Incidence of Neonatal Respiratory Morbidity After Elective Cesarean Section at Term: A Prospective Double Blinded Placebo Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Makassed General Hospital · Academic / Other
• Sex: Female
• Age: 17 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing elective C-section will be randomized into two groups. The first group will receive one dose of Betamethasone at least 24 hours before scheduled C-section. The second group will receive placebo.

Detailed description

This is a prospective double blinded randomized clinical trial. Patients will be randomized into two groups. Group A will receive one dose of Betamethasone at least 24 hours before scheduled C-section. Group B will receive placebo. The maternal and neonatal outcomes will be studied in order to assess the effect of Betamethasone on respiratory morbidity of the newborn infant.

Conditions

• Respiratory Morbidity

Interventions

Type	Name	Description
OTHER	Betamethasone	A single injection will be administered to the patient at least 24 hours before undergoing C-section. This injection will be prepared in the hospital's pharmacy to contain betamethasone
OTHER	Placebo	A single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline.

Timeline

• Start date: 2020-05-29
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2020-05-29
• Last updated: 2020-06-01

Locations

1 site across 1 country: Lebanon