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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: May 2021

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Betamethasone
    • Patients will receive 14 mg (2 ml) intramuscular betamethasone
  • Placebo Comparator: Placebo
    • Patients will receive an equivalent volume of normal saline

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 17 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Makassed General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Manal Hubeish, Principal Investigator – Makassed General Hospital
  • Overall Official(s)
    • Manal Hubeish, MD, Principal Investigator, Makassed General Hospital
  • Overall Contact(s)
    • Manal Hubeish, MD, +9611636297, drmanalhubeishhusari@gmail.com

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