Progestrone and Doppler Indices

Study Overview
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Brief Summary
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The aim of our study is to assess the effect of vaginal progestrone on fetal and maternal doppler indices

Detailed Description
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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.

Official Title
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The Effect of Vaginal Progestrone on Fetal and Maternal Doppler Indices

Conditions
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Preterm Labor

Intervention / Treatment
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* Diagnostic Test: A complete Doppler ﬂow assessment of the maternal and fetal circulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: vaginal progestrone group<br>cohort of patients who received 400mg vaginal progestrone . | Diagnostic Test: A complete Doppler ﬂow assessment of the maternal and fetal circulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | before and 48 hours after progestrone admistration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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progestrone, doppler indices