NCT03396107

Brief Summary

Caesarean section is a risk factor for the development of neonatal respiratory complications, mostly respiratory distress syndrome (RDS) and transient tachypnoea of the new-born, both in term and preterm infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
498

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

May 17, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2020

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

1.5 years

First QC Date

January 5, 2018

Last Update Submit

June 18, 2021

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • Incidence of respiratory complications after cesarean section

    To determine respiratory distress in infants born by elective cesarean section

    30 min

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone 6mg, IM, 48 hours before cesarean section

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Placebo 6mg, IM, 48 hours before cesarean section

Drug: Placebo

Interventions

DexamethasoneDRUG

Dexamethasone 6mg, IM, 48 hours before cesarean section

Dexamethasone
PlaceboDRUG

Placebo 6mg, IM, 48 hours before cesarean section

Also known as: Saline
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Maternal age (18-35 years)
  • Singleton pregnancy
  • Gestational age (38-40 years)

You may not qualify if:

  • Major maternal morbidities as DM and pre-eclampsia
  • Sever oligohydramnios
  • Premature rupture of membranes
  • Women who receive steroids during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (1)

  • Barber EL, Lundsberg LS, Belanger K, Pettker CM, Funai EF, Illuzzi JL. Indications contributing to the increasing cesarean delivery rate. Obstet Gynecol. 2011 Jul;118(1):29-38. doi: 10.1097/AOG.0b013e31821e5f65.

    PMID: 21646928BACKGROUND

MeSH Terms

Interventions

DexamethasoneSodium Chloride

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ahmed Fayek, Professor

    Assiut University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 10, 2018

Study Start

May 17, 2018

Primary Completion

November 25, 2019

Study Completion

May 24, 2020

Last Updated

June 21, 2021

Record last verified: 2021-06

Locations

EG(1)