Dexamethasone Before Elective Cesarean Section at Term in Reducing Neonatal Respiratory Distress Syndrome

Role of Prophylactic Dexamethasone Administration Before Elective Cesarean Section at Term in Reducing the Incidence of Neonatal Respiratory Distress Syndrome (A Randomized Controlled Trial)

Prophylactic antenatal administration of corticosteroid enhance fetal lung maturity and reduce the probability of respiratory morbidity in preterm births.

assessment of administration of four doses intramuscular dexamethasone 48h before elective cesarean section at term in reducing the incidence of neonatal respiratory distress syndrome and NICU admission as a result

Study Overview

• Status: Not yet recruiting
• Conditions: C08.381.840.500.475; C08.381.840.500.737
• Intervention / Treatment: Drug: Dexamethasone phosphate

Detailed Description

Term neonates born between (37-39 wks) by elective cesarean section are likely to develop respiratory distress syndrome more than neonates born by vaginal delivery, and this risk increases for the subgroup of neonates born after elective caeserean section , i.e. before onset of labour , , with potentially severe implications The risk is decreasing with advanced gestational age and neonates born in 37 weeks are at 1.7 times more than those born at 38 weeks , which in turn are at 2.4 times more than those born at 39 weeks If the pregnant female is given four intramuscular injections of 6 mg of dexamethasone , 48 hrs before elective caesarean section decreases the neonatal respiratory morbidity. Five studies lasting between 3 to 20 years with more than 1500 patients have shown no adverse effect of single course of antenatal corticosteroid , neither through infection of the fetus or mother nor in long term neurological or cognitive effect According to Cochrane Database of Systematic Reviews 2018 , prophylactic administration of antenatal corticosteroids appeared to reduce the rate of RDS by approximately 52%. It also reduced the need for NICU admission, both due to respiratory morbidity (by approximately 58%) and for any indication. The reduction of NICU admissions due to respiratory reasons is consistent with the reduction of respiratory morbidity after corticosteroid administration

• Study Type: Interventional
• Enrollment (Anticipated): 950
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahmed M Abass, MD; Phone Number: 02 01066903903; Email: ahmedmams@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Gestational age (37-39wks).
• Singleton pregnancy.
• Didn't receive any steroid treatment during pregnancy.

Exclusion Criteria:

• Undetermined gestational age
• Maternal chronic diseases (e.g: hypertension, DM-2) to avoid any side effects of steroid use and to keep the pregnant 's case from getting worse.
• Congenital fetal malformations
• Emergency CS
• Pregnant refusing to participate in the study or unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Steroid Group; Participants will receive 4 doses of dexamethasone 6mg IM 48h before elective CS.	Drug: Dexamethasone phosphate; 4 doses of dexamethasone 6mg IM 48h before elective CS.
NO_INTERVENTION: No Steroid Group; Participants will receive No treatment before elective CS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of neonatal respiratory distress syndrome (RDS)	1st 6 hours after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APGAR score	A: Activity/muscle tone 0 points: limp or floppy; point: limbs flexed; points: active movement P: Pulse/heart rate 0 points: absent; point: less than 100 beats per minute; points: greater than 100 beats per minute G: Grimace (response to stimulation, such as suctioning the baby's nose) 0 points: absent; point: facial movement/grimace with stimulation; points: cough or sneeze, cry and withdrawal of foot with stimulation A: Appearance (color) 0 points: blue, bluish-gray, or pale all over; point: body pink but extremities blue; points: pink all over R: Respiration/breathing 0 points: absent; point: irregular, weak crying; points: good, strong cry	1 min after delivery
APGAR score	A: Activity/muscle tone 0 points: limp or floppy; point: limbs flexed; points: active movement P: Pulse/heart rate 0 points: absent; point: less than 100 beats per minute; points: greater than 100 beats per minute G: Grimace (response to stimulation, such as suctioning the baby's nose) 0 points: absent; point: facial movement/grimace with stimulation; points: cough or sneeze, cry and withdrawal of foot with stimulation A: Appearance (color) 0 points: blue, bluish-gray, or pale all over; point: body pink but extremities blue; points: pink all over R: Respiration/breathing 0 points: absent; point: irregular, weak crying; points: good, strong cry	5 min after delivery
Rate of Neonatal intraventricular hemorrhage (IVH)		within 1st 48 hours after delivery

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Hassan Awad, Professor, AinSU

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): April 1, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (ACTUAL): March 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Dexamethasone 21-phosphate
• Other Study ID Numbers: Steroids for lung maturity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No