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

C08.381.840.500.475 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04816097
• Other study ID #: Steroids for lung maturity
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: March 2021
• Source: Ain Shams University
• Contact: Ahmed M Abass, MD
• Phone: 02 01066903903
• Email: ahmedmams[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 950
• Est. completion date: April 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• C08.381.840.500.475
• C08.381.840.500.737
• Hyaline Membrane Disease
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Dexamethasone phosphate
4 doses of dexamethasone 6mg IM 48h before elective CS.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of neonatal respiratory distress syndrome (RDS)		1st 6 hours after delivery
Secondary	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
Secondary	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
Secondary	Rate of Neonatal intraventricular hemorrhage (IVH)		within 1st 48 hours after delivery