C08.381.840.500.475, C08.381.840.500.737
Conditions
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
Interventions
DRUGDexamethasone phosphate
4 doses of dexamethasone 6mg IM 48h before elective CS.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of neonatal respiratory distress syndrome (RDS) | 1st 6 hours after delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| APGAR score | 1 min after delivery | A: Activity/muscle tone 0 points: limp or floppy 1. point: limbs flexed 2. points: active movement P: Pulse/heart rate 0 points: absent 1. point: less than 100 beats per minute 2. points: greater than 100 beats per minute G: Grimace (response to stimulation, such as suctioning the baby's nose) 0 points: absent 1. point: facial movement/grimace with stimulation 2. points: cough or sneeze, cry and withdrawal of foot with stimulation A: Appearance (color) 0 points: blue, bluish-gray, or pale all over 1. point: body pink but extremities blue 2. points: pink all over R: Respiration/breathing 0 points: absent 1. point: irregular, weak crying 2. points: good, strong cry |
| Rate of Neonatal intraventricular hemorrhage (IVH) | within 1st 48 hours after delivery | — |
Contacts
Primary ContactAhmed M Abass, MD
Outcome results
None listed