Back to resultsDexamethasone on Fetal and Uteroplacental Doppler
Primary Purpose
Preterm Birth
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Doppler
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Birth
Eligibility Criteria
Inclusion Criteria:
- Patients at risk of preterm labor to be included were those with preterm uterine contractions, placenta previa, and mild preeclampsia
Exclusion Criteria:
- 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
Sites / Locations
- Ahmed Abbas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Preterm
Arm Description
Outcomes
Primary Outcome Measures
mean of Doppler Resistance index (RI)
Secondary Outcome Measures
mean of Doppler Pulsatility index (PI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02662790
Brief Title
Dexamethasone on Fetal and Uteroplacental Doppler
Official Title
Effects of Antenatal Dexamethasone Administration on Fetal and Uteroplacental Doppler Waveforms in Women at Risk for Preterm Birth
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preterm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Doppler
Primary Outcome Measure Information:
Title
mean of Doppler Resistance index (RI)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
mean of Doppler Pulsatility index (PI)
Time Frame
24 hours
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients at risk of preterm labor to be included were those with preterm uterine contractions, placenta previa, and mild preeclampsia
Exclusion Criteria:
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
Facility Information:
Facility Name
Ahmed Abbas
City
Assiut
State/Province
Cairo
ZIP/Postal Code
002
Country
Egypt
12. IPD Sharing Statement
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Dexamethasone on Fetal and Uteroplacental Doppler
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