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Clinical Trials/NCT04816097
NCT04816097
Unknown
Phase 4

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

Ain Shams University0 sites950 target enrollmentApril 1, 2021

Overview

Phase
Phase 4
Intervention
Dexamethasone phosphate
Conditions
C08.381.840.500.475
Sponsor
Ain Shams University
Enrollment
950
Primary Endpoint
incidence of neonatal respiratory distress syndrome (RDS)
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
April 1, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Abass

Lecturer

Ain Shams University

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

Arms & Interventions

Steroid Group

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

Intervention: Dexamethasone phosphate

Outcomes

Primary Outcomes

incidence of neonatal respiratory distress syndrome (RDS)

Time Frame: 1st 6 hours after delivery

Secondary Outcomes

  • APGAR score(5 min after delivery)
  • Rate of Neonatal intraventricular hemorrhage (IVH)(within 1st 48 hours after delivery)

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