Dexamethasone Before Elective Cesarean Section at Term in Reducing Neonatal Respiratory Distress Syndrome
Primary Purpose
C08.381.840.500.475, C08.381.840.500.737
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexamethasone phosphate
Sponsored by
About this trial
This is an interventional prevention trial for C08.381.840.500.475
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Steroid Group
No Steroid Group
Arm Description
Participants will receive 4 doses of dexamethasone 6mg IM 48h before elective CS.
Participants will receive No treatment before elective CS.
Outcomes
Primary Outcome Measures
incidence of neonatal respiratory distress syndrome (RDS)
Secondary Outcome Measures
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
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
Rate of Neonatal intraventricular hemorrhage (IVH)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04816097
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C08.381.840.500.475, C08.381.840.500.737
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
950 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Steroid Group
Arm Type
Active Comparator
Arm Description
Participants will receive 4 doses of dexamethasone 6mg IM 48h before elective CS.
Arm Title
No Steroid Group
Arm Type
No Intervention
Arm Description
Participants will receive No treatment before elective CS.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone phosphate
Intervention Description
4 doses of dexamethasone 6mg IM 48h before elective CS.
Primary Outcome Measure Information:
Title
incidence of neonatal respiratory distress syndrome (RDS)
Time Frame
1st 6 hours after delivery
Secondary Outcome Measure Information:
Title
APGAR score
Description
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
Time Frame
1 min after delivery
Title
APGAR score
Description
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
Time Frame
5 min after delivery
Title
Rate of Neonatal intraventricular hemorrhage (IVH)
Time Frame
within 1st 48 hours after delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Abass, MD
Phone
02 01066903903
Email
ahmedmams@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Awad, Professor
Organizational Affiliation
AinSU
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dexamethasone Before Elective Cesarean Section at Term in Reducing Neonatal Respiratory Distress Syndrome
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