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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
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for C08.381.840.500.475

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    March 23, 2021
    Last Updated
    March 24, 2021
    Sponsor
    Ain Shams University
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    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

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

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