NCT02978976

Brief Summary

The aim of this study is to determine the effect of administering antenatal steroids in term fetuses on the blood flow in the fetal pulmonary artery, and to correlate these findings with clinical data obtained after birth documenting respiratory disorders.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

October 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

October 22, 2016

Last Update Submit

November 15, 2017

Conditions

Neonatal Respiratory Distress

Keywords

RDSDoppler on fetal pulmonary artery

Outcome Measures

Primary Outcomes (1)

  • changes in the mean doppler parameters between the study groups before and after the drug administration ( compare means of doppler reading between both groups using t-test)

    1 week

Secondary Outcomes (1)

  • Presense of respiratory disorders in neonate (yes/no)

    8 days

Study Arms (2)

betamethasone

EXPERIMENTAL

will receive two doses of 12mg betamethasone, then the pulsatility index (PI), resistance index (RI), systolic/diastolic ratio (SD), and the acceleration-time/ejection-time ratio (At/Et) will be determined in all cases after recruitment, just before the administration of the drug (betamethasone), 24 hours after the last dose, and on the day of elective Cs.

Drug: Betamethasone

Saline

PLACEBO COMPARATOR

will receive saline injection placebo, then the pulsatility index (PI), resistance index (RI), systolic/diastolic ratio (SD), and the acceleration-time/ejection-time ratio (At/Et) will be determined in all cases after recruitment, just before the administration of the drug ( placebo), 24 hours after the last dose, and on the day of elective Cs.

Drug: saline

Interventions

BetamethasoneDRUG

will receive two doses of 12mg betamethasone ( Dipropfos ® SCHERING-PLOUGH; Kenilworth, New Jersey, USA) intramuscularly (IM) 24 hours apart.

Also known as: Dipropfos
betamethasone
salineDRUG

saline placebo injection in the same regimen.

Also known as: NaCl 0.9
Saline

Eligibility Criteria

Age28 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • indication for elective caesarean section.
  • weeks +6days

You may not qualify if:

  • hypertensive
  • diabetic
  • any disorder that may be aggravated by administration of steroids
  • women with systemic infection including tuberculosis or sepsis
  • any fetal congenital anomalies (affecting the fetal heart, lungs, and circulation)
  • history of rupture membranes, or suspected chorioamnionitis
  • intrauterine growth retardation (IUGR)
  • intrauterine fetal demise (IUFD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

11562

Cairo, 11562, Egypt

RECRUITING

Related Publications (1)

  • Bartha JL, Largo-Heinrich M, Machado MJ, Gonzalez-Bugatto F, Hervias-Vivancos B. Effects of antenatal betamethasone on human fetal branch pulmonary artery flow velocity waveforms. Fetal Diagn Ther. 2008;23(1):46-53. doi: 10.1159/000109226. Epub 2007 Oct 9.

    PMID: 17934298BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

BetamethasoneSodium Chloride

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ahmed Kamel, M.D.

    Lecturer Of obstetrics and gynecology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Kamel, M.D.

CONTACT

00201120022332dr.ahmed.m.kamel@gmail.com

Emad Salah, M.D.

CONTACT

emadsalah148@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrtics & gynecology

Study Record Dates

First Submitted

October 22, 2016

First Posted

December 1, 2016

Study Start

January 1, 2017

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

yes

Locations

EG(1)