NCT04816097

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
950

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 23, 2021

Last Update Submit

March 24, 2021

Conditions

C08.381.840.500.475C08.381.840.500.737

Outcome Measures

Primary Outcomes (1)

  • incidence of neonatal respiratory distress syndrome (RDS)

    1st 6 hours after delivery

Secondary Outcomes (3)

  • APGAR score

    1 min after delivery

  • APGAR score

    5 min after delivery

  • Rate of Neonatal intraventricular hemorrhage (IVH)

    within 1st 48 hours after delivery

Study Arms (2)

Steroid Group

ACTIVE COMPARATOR

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

Drug: Dexamethasone phosphate

No Steroid Group

NO INTERVENTION

Participants will receive No treatment before elective CS.

Interventions

Dexamethasone phosphateDRUG

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

Steroid Group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age (37-39wks).
  • Singleton pregnancy.
  • Didn't receive any steroid treatment during pregnancy.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

dexamethasone 21-phosphate

Study Officials

  • Hassan Awad, Professor

    AinSU

    STUDY CHAIR

Central Study Contacts

Ahmed M Abass, MD

CONTACT

02 01066903903ahmedmams@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

April 1, 2021

Primary Completion

October 1, 2021

Study Completion

April 1, 2022

Last Updated

March 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share