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

Makassed General Hospital400 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

400

Conditions

Respiratory Morbidity

Interventions

BetamethasoneOTHER

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

PlaceboOTHER

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

Eligibility

Sex: FEMALEMin age: 17 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Makassed General Hospital

Beirut, Lebanon

RECRUITING

Outcomes

Primary Outcomes

Percentage of patients with respiratory morbidity

Neonatal respiratory morbidity will be assessed through oxygen saturation, Apgar score and Silverman score

Time frame: at birth

Secondary Outcomes

Admission to Neonatal Intensive Care Unit (NICU)

Reasons for NICU admission and length of stay

Time frame: up to 2 weeks

Central Contacts

Manal Hubeish, MD

CONTACT

+9611636297 drmanalhubeishhusari@gmail.com

Data from ClinicalTrials.gov

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