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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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C08.381.840.500.475, C08.381.840.500.737

Intervention / Treatment
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* Drug: Dexamethasone phosphate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid Group<br>Participants will receive 4 doses of dexamethasone 6mg IM 48h before elective CS. | Drug: Dexamethasone phosphate<br>* 4 doses of dexamethasone 6mg IM 48h before elective CS.<br>|
| No Intervention: No Steroid Group<br>Participants will receive No treatment before elective CS. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |