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

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Morbidity
• Intervention / Treatment: Other: Betamethasone; Other: 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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manal Hubeish, MD; Phone Number: +9611636297; Email: drmanalhubeishhusari@gmail.com

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • Makassed General Hospital
    • Contact: Manal Hubesih, MD; Phone Number: 6297 +9611636000; Email: drmanalhubesihhusari@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Betamethasone; Patients will receive 14 mg (2 ml) intramuscular betamethasone	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 Comparator: Placebo; Patients will receive an equivalent volume of normal saline	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with respiratory morbidity	Neonatal respiratory morbidity will be assessed through oxygen saturation, Apgar score and Silverman score	at birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admission to Neonatal Intensive Care Unit (NICU)	Reasons for NICU admission and length of stay	up to 2 weeks

Collaborators and Investigators

• Sponsor: Makassed General Hospital
• Investigators: Principal Investigator: Manal Hubeish, MD, Makassed General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone
• Other Study ID Numbers: 642020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No