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

Ain Shams University

Status and phase: Unknown; Phase 4

Conditions: C08.381.840.500.737; C08.381.840.500.475

Treatments: Drug: Dexamethasone phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT04816097

Steroids for lung maturity

Details and patient eligibility

About

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

Full 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

Enrollment: 950 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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950 participants in 2 patient groups

Steroid Group

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone phosphate

No Steroid Group

No Intervention group

Description:

Participants will receive No treatment before elective CS.