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

NCT ID: NCT04816097

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 950 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-04-01

Brief 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

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

Conditions

C08.381.840.500.475; C08.381.840.500.737

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Steroid Group

Participants will receive 4 doses of dexamethasone 6mg IM 48h before elective CS.

Group Type: ACTIVE_COMPARATOR

Dexamethasone phosphate

Intervention Type: DRUG

4 doses of dexamethasone 6mg IM 48h before elective CS.

No Steroid Group

Participants will receive No treatment before elective CS.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dexamethasone phosphate

4 doses of dexamethasone 6mg IM 48h before elective CS.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abass

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hassan Awad, Professor

Role: STUDY_CHAIR

AinSU

Central Contacts

Ahmed M Abass, MD

Role: CONTACT

ahmedmams@hotmail.com

02 01066903903

Other Identifiers

Steroids for lung maturity

Identifier Type: -

Identifier Source: org_study_id