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JZ Thickness as a Predictor of Recurrent Unexplained First Trimesteric Pregnancy Loss. (JZ)

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ClinicalTrials.gov Identifier: NCT03054558
Recruitment Status : Unknown
Verified April 2018 by sherine Hosny Mohamed Gad Allah, Cairo University.
Recruitment status was:  Recruiting
First Posted : February 15, 2017
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
sherine Hosny Mohamed Gad Allah, Cairo University

Brief Summary:
Patients with history of two or more recurrent pregnancy loss (RPL) and no history of living babies who had performed all investigations for recurrent miscarriage (RM) including : laboratory investigation ,trans vaginal ultrasound (TVS) ,autoimmune work up and hystroscopy and all results were free,will be scheduled for three dimensional trans-vaginal ultrasound (3D TVS) in the midluteal phase for measuring the impedance of uterine artery blood flow( by two dimensional Power Doppler TVS).Also by using 3D power Doppler the sub-endometrial blood flow will be assessed. In addition to the thickness of Junctional Zone (JZ) by using coronal view of 3 D TVS. To be compared with patients who had at least one full term living baby through normal vaginal delivery with no history of early pregnancy loss.

Condition or disease Intervention/treatment
Patients With Recurrent Unexplained Pregnancy Loss Other: Pelvic ultrasound both two dimensional and three dimentional

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Predictive Value of Junctional Zone Thickness in Combination With Three Dimensional Power Doppler and Uterine Artery Vascular Indices in Patients With Recurrent Unexplained Pregnancy Loss; A New Diagnostic Tool.
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Group/Cohort Intervention/treatment
patients with recurrent unexplained pregnancy loss
Patients with history of two or more recurrent pregnancy loss (RPL) and no history of living babies who had performed all investigations for recurrent miscarriage (RM) including : laboratory investigation ,trans vaginal ultrasound (TVS) ,autoimmune work up and hystroscopy and all results were free
Other: Pelvic ultrasound both two dimensional and three dimentional
Healthy fertile patients
Healthy fertile patients with no history of previous miscarriage and have at least one uncomplicated pregnancy with no pelvic pathology
Other: Pelvic ultrasound both two dimensional and three dimentional



Primary Outcome Measures :
  1. Thickness of junctional zone [ Time Frame: immediatly measured by 3D TVS ]
    Measured in coronal view of 3DTVS


Secondary Outcome Measures :
  1. Uterine artery Doppler Indices [ Time Frame: immediatly measured by 2D power Doppler TVS ]
    measuring uterine artery pulsativity index (PI)

  2. Subendometrial blood flow [ Time Frame: immediatly measured by 3d power Doppler TVS ]
    Measuring flow index (FI) ,vascularization index(VI) and vascularization flow index(VFI)

  3. Endometrial thickness [ Time Frame: immediatly measured by 2D power Doppler TVS ]
    measuring endometrial thickness by 2d TVS (longitudinal view)



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Young females with history of two or more consecutive unexplained pregnancy loss who attend Kasr alainy out patient clinic seeking for fertility..

Control group are healthy females of the same age group with no history of pregnancy loss and history of at least one full term healthy pregnancy who attends outpatient clinic for routine check up

Criteria

Inclusion Criteria:

  • Females with history of recurrent pregnancy loss
  • for control group healthy females with history of at least one uncomplicated full pregnancy.

Exclusion Criteria:

  • no history of endocrinal disorders
  • no history of immunological diseases
  • no history of pelvic pathology
  • no history of uterine anomalies or cervical incompetence As a cause of recurrent pregnancy loss

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054558


Contacts
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Contact: Sherine H Gad Allah, MD 01097665573 ext +2 sheribehosny@gmail.com
Contact: Sherine H Gad Allah, MD 01097885573 ext +2 sherinehosny@gmail.com

Locations
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Egypt
Kasr AlAini teaching hospital Recruiting
Cairo, Egypt, 1243
Contact: Sherine H Gad Allah, MD    01097665573 ext +2    sherinehosny@gmail.com   
Sponsors and Collaborators
sherine Hosny Mohamed Gad Allah
Investigators
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Principal Investigator: Sherine H Gad Allah, MD kasr al aini teaching hospital
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Responsible Party: sherine Hosny Mohamed Gad Allah, Assisstant professor of obs and gyne cairo uneveristy ,MD, Cairo University
ClinicalTrials.gov Identifier: NCT03054558    
Other Study ID Numbers: C111
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Keywords provided by sherine Hosny Mohamed Gad Allah, Cairo University:
Junctional zone
recurrent pregnancy loss
3D power Doppler
Additional relevant MeSH terms:
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Abortion, Spontaneous
Fetal Death
Pregnancy Complications
Death
Pathologic Processes