Progestrone and Doppler Indices

Overview

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

Full Title of Study: “The Effect of Vaginal Progestrone on Fetal and Maternal Doppler Indices”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2017

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.

Interventions

  • Diagnostic Test: A complete Doppler flow assessment of the maternal and fetal circulation
    • 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.

Arms, Groups and Cohorts

  • Other: vaginal progestrone group
    • cohort of patients who received 400mg vaginal progestrone .

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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 andor effacement) in current pregnancy Exclusion Criteria:

  • PPROM – Contraindication to progesterone use – Diabetic patients, have glucose intolerance – Multiple pregnancies

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kasr El Aini Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: sarah mohamed hassan, lecturer of obstetrics and gynecology Cairo university – Kasr El Aini Hospital

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