Back to resultsProgestrone and Doppler Indices
Primary Purpose
Preterm Labor
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
A complete Doppler flow assessment of the maternal and fetal circulation
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Labor focused on measuring progestrone, doppler indices
Eligibility Criteria
Inclusion Criteria:
- Gestational age: 18-33 weeks
- Willing and able to give informed consent
- History of preterm labor (<34 weeks)
- At risk for preterm labor ( increased amniotic fluid volume)
- Short cervical length (<25mm) as incidental finding
- Presenting with actual cervical changes ( dilatation and\or effacement) in current pregnancy
Exclusion Criteria:
- PPROM
- Contraindication to progesterone use
- Diabetic patients, have glucose intolerance
- Multiple pregnancies
Sites / Locations
- Kasr El Ainiy Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
vaginal progestrone group
Arm Description
cohort of patients who received 400mg vaginal progestrone .
Outcomes
Primary Outcome Measures
change of ultrasound doppler indices.
A complete Doppler flow assessment of the maternaland fetal circulation was conducted by an independent investigator blinded to the treatment, before and 48 hours after the first administration of progesterone, Voluson E8 (GE Healthcare, Zipf, Austria) ultrasoundmachine,equippedwitha3.5-MHzcurvilinearabdominaltransducer with color imaging capabilities, was used in all cases.
Secondary Outcome Measures
Full Information
NCT ID
NCT03292939
First Posted
September 20, 2017
Last Updated
October 10, 2017
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03292939
Brief Title
Progestrone and Doppler Indices
Official Title
The Effect of Vaginal Progestrone on Fetal and Maternal Doppler Indices
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of our study is to assess the effect of vaginal progestrone on fetal and maternal doppler indices
Detailed Description
A complete Doppler flow assessment of the maternal and fetal circulation was conducted by an independent investigator blinded to the treatment, before and 48 hours after the first administration of 400mg of vaginal progesterone, Voluson E8 (GE Healthcare, Zipf, Austria) ultrasound machine,equipped with a 3.5- MHz curvilinear abdominal transducer with color imaging capabilities, was used in all cases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
Keywords
progestrone, doppler indices
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vaginal progestrone group
Arm Type
Other
Arm Description
cohort of patients who received 400mg vaginal progestrone .
Intervention Type
Diagnostic Test
Intervention Name(s)
A complete Doppler flow assessment of the maternal and fetal circulation
Intervention Description
A complete Doppler flow assessment of the maternal and fetal circulation was conducted by an independent investigator blinded to the treatment, 48 hours after receiving 400mg of vaginal progestrone .Voluson E8 (GE Healthcare, Zipf, Austria) ultrasound machine ,equipped with a 3.5-MHz curvilinear abdominal transducer with color imaging capabilities, was used in all cases.
Primary Outcome Measure Information:
Title
change of ultrasound doppler indices.
Description
A complete Doppler flow assessment of the maternaland fetal circulation was conducted by an independent investigator blinded to the treatment, before and 48 hours after the first administration of progesterone, Voluson E8 (GE Healthcare, Zipf, Austria) ultrasoundmachine,equippedwitha3.5-MHzcurvilinearabdominaltransducer with color imaging capabilities, was used in all cases.
Time Frame
before and 48 hours after progestrone admistration
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age: 18-33 weeks
Willing and able to give informed consent
History of preterm labor (<34 weeks)
At risk for preterm labor ( increased amniotic fluid volume)
Short cervical length (<25mm) as incidental finding
Presenting with actual cervical changes ( dilatation and\or effacement) in current pregnancy
Exclusion Criteria:
PPROM
Contraindication to progesterone use
Diabetic patients, have glucose intolerance
Multiple pregnancies
Facility Information:
Facility Name
Kasr El Ainiy Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Progestrone and Doppler Indices
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