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

Not Applicable

• Conditions: Respiratory Morbidity
• Interventions: Other: Betamethasone; Other: Placebo

• Registration Number: NCT04407975
• Lead Sponsor: Makassed General Hospital

Brief 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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-28
• Study Start: 2020-05-29
• Study First Posted: 2020-05-29
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-01
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• women with singleton or multiple gestation,
• between 37 and 40 weeks of pregnancy (as calculated from the first day of the last menstrual period)

Exclusion Criteria

• any medical problem that could affect fetal well-being;
• evidence of intrauterine infection,
• oligohydramnios,
• fetal congenital malformations,
• preeclampsia,
• maternal hypertension,
• severe fetal rhesus sensitization,
• antepartum hemorrhage,
• Intrauterine growth restriction
• preterm rupture of membranes
• preterm delivery
• previously received antenatal steroids less than one month ago
• those who decline to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Betamethasone	Betamethasone	Patients will receive 14 mg (2 ml) intramuscular betamethasone
Placebo	Placebo	Patients will receive an equivalent volume of normal saline

Primary Outcome Measures

Name	Time	Method
Percentage of patients with respiratory morbidity	at birth	Neonatal respiratory morbidity will be assessed through oxygen saturation, Apgar score and Silverman score

Secondary Outcome Measures

Name	Time	Method
Admission to Neonatal Intensive Care Unit (NICU)	up to 2 weeks	Reasons for NICU admission and length of stay

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon