Clinical trial NCT04816097: Dexamethasone Before Elective Cesarean Section at Term in Reducing Neonatal Respiratory Distress Syndrome
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: C08.381.840.500.475
C08.381.840.500.737
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 950
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: incidence of neonatal respiratory distress syndrome (RDS)
timeFrame: 1st 6 hours after delivery
Secondary outcomes:
measure: APGAR score
timeFrame: 1 min after delivery
measure: APGAR score
timeFrame: 5 min after delivery
measure: Rate of Neonatal intraventricular hemorrhage (IVH)
timeFrame: within 1st 48 hours after delivery
Other outcomes:
Locations:
Study officials:
affiliation: AinSU
name: Hassan Awad, Professor
role: STUDY_CHAIR
References: