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

Respiratory Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04407975
• Other study ID #: 642020
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2020
• Est. completion date: May 2021

Study information

• Verified date: May 2020
• Source: Makassed General Hospital
• Contact: Manal Hubeish, MD
• Phone: +9611636297
• Email: drmanalhubeishhusari[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Morbidity

Intervention

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
• Placebo
A single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline.

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with respiratory morbidity	Neonatal respiratory morbidity will be assessed through oxygen saturation, Apgar score and Silverman score	at birth
Secondary	Admission to Neonatal Intensive Care Unit (NICU)	Reasons for NICU admission and length of stay	up to 2 weeks