NCT02662790

Brief Summary

The current study aims to investigate the effects of dexamethasone exerted on fetal and uteroplacental circulation as measured by Doppler ultrasonography in pregnancies at risk for preterm birth after 24 hours of its administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

January 15, 2016

Last Update Submit

January 21, 2016

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • mean of Doppler Resistance index (RI)

    24 hours

Secondary Outcomes (1)

  • mean of Doppler Pulsatility index (PI)

    24 hours

Study Arms (1)

Preterm

EXPERIMENTAL
Other: Doppler

Interventions

DopplerOTHER
Preterm

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients at risk of preterm labor to be included were those with preterm uterine contractions, placenta previa, and mild preeclampsia

You may not qualify if:

  • Patients who were actively in labor, presented with premature rupture of membranes, intrauterine growth restriction (IUGR), those who had received corticosteroids in their pregnancies and/or fetuses with suspected structural abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 26, 2016

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

EG(1)