- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03292939
Progestrone and Doppler Indices
October 10, 2017 updated by: sarah mohamed hassan, Kasr El Aini Hospital
The Effect of Vaginal Progestrone on Fetal and Maternal Doppler Indices
The aim of our study is to assess the effect of vaginal progestrone on fetal and maternal doppler indices
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11562
- Kasr El Ainiy Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: vaginal progestrone group
cohort of patients who received 400mg vaginal progestrone .
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of ultrasound doppler indices.
Time Frame: before and 48 hours after progestrone admistration
|
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.
|
before and 48 hours after progestrone admistration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
September 20, 2017
First Submitted That Met QC Criteria
September 25, 2017
First Posted (Actual)
September 26, 2017
Study Record Updates
Last Update Posted (Actual)
October 11, 2017
Last Update Submitted That Met QC Criteria
October 10, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7880
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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