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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

Tracking Information
First Submitted Date February 11, 2017
First Posted Date February 15, 2017
Last Update Posted Date April 10, 2018
Actual Study Start Date December 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2017)
Thickness of junctional zone [ Time Frame: immediatly measured by 3D TVS ]
Measured in coronal view of 3DTVS
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 11, 2017)
  • Uterine artery Doppler Indices [ Time Frame: immediatly measured by 2D power Doppler TVS ]
    measuring uterine artery pulsativity index (PI)
  • Subendometrial blood flow [ Time Frame: immediatly measured by 3d power Doppler TVS ]
    Measuring flow index (FI) ,vascularization index(VI) and vascularization flow index(VFI)
  • Endometrial thickness [ Time Frame: immediatly measured by 2D power Doppler TVS ]
    measuring endometrial thickness by 2d TVS (longitudinal view)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title JZ Thickness as a Predictor of Recurrent Unexplained First Trimesteric Pregnancy Loss.
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.
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.
Detailed Description

Among patients attending the Recurrent pregnancy loss outpatient clinic of kasr Al Aini teaching hospital, Cairo University .Those meeting investigators inclusion criteria will be selected for the study. All patients had a history of two or more consecutive, first trimester miscarriages. Patients with two miscarriages will be included in the study since equal frequencies of abnormal test results have been demonstrated among patients with two miscarriages or more . Accordingly, the American College of Obstetrics and Gynecologists states that the evaluation of couples with two consecutive miscarriages should be initiated.

All women will undergo an extensive examination ,investigations (laboratory ,TVS and hystroscopy) in order to evaluate all known etiological factors for RPL.

Only Patients with free examination and normal investigations will be enrolled in our study.

Healthy fertile women who attended the outpatient clinic of obstetrics and gynecology in kasr Al Aini hospital ,Cairo university,for a routine scan will be recruited for the control group. Inclusion criteria required the absence of previous miscarriages and the presence of at least one previous uncomplicated pregnancy. Women with a history of pelvic disease or with abnormal findings during the ultrasound examination were excluded from the study.

The thickness and the morphology of the JZ will be evaluated on the uterine coronal view obtained by 3D TVS. Endometrial thickness with be measured and subendometrial blood flow ( vascularization index VI ,flow index FI and vascularization flow index VFI ) will be obtained by 3D power Doppler .

The sonographic evaluation will be performed in the midluteal phase of the cycle (18th to 22nd cycle day), to avoid possible hormonal influences, using an E8 (GE Healthcare, Zipf, Austria) ultrasound machine equipped with a multifrequency 3D volume endovaginal probe (2.8-10 MHz).

The examination included a 2D-TVS evaluation of the pelvic organs to exclude any abnormalities. Transvaginal Doppler flow measurement of the impendence to uterine artery blood flow was performed.

In order to evaluate the JZ the coronal view of the uterus will be obtained using 3D-TVS. Two to four static grey-scale volumes of the uterus will be obtained from the sagittal plane and from the transverse plane. The volume acquisition technique will be performed in a standardized fashion.

Recent studies indicate that the use of these criteria allow to an assessment of the JZ reproducible enough to be used in clinical practice. In particular: frequency, 6-9 MHz; magnification of the uterus up to half of the screen; sweep angle, 1208; sweep velocity will be adjusted from medium to maximum quality; 3D volume box exceeding the uterus by 1 cm on each side.

The coronal view reconstruction technique involved placing a straight or curved line (OmniView or rendering mode) along the endometrial stripe on the sagittal and transverse views. The multiplanar view was then manipulated until a satisfactory coronal image is obtained of the uterine external profile and the cavity, with bilateral visualization of the interstitial portion of the Fallopian tube. Volume contrast imaging (VCI) is applied (2- 4 mm slice thickness) with volume rendering (mixed light surface and gradient light). Following acquisition, ultrasound volumes will be stored for subsequent offline analysis. On the coronal view the JZ appears as a hypo-echoic zone around the endometrium. JZ measurements are therefore performed only on 3D multi-planar view using VCI. Disruption and infiltration of the hypo-echoic JZ by the hyper-echoic endometrial tissue are evaluated and the JZ thickness is measured as the distance from the basal endometrium to the internal layer of the outer myometrium. The minimum (JZmin), the maximum (JZmax) and the difference between the maximum and the minimum JZ (JZmax - JZmin) thickness are assessed. The JZmax and the JZmin are defined as the largest and smallest JZ thickness measured on a coronal or longitudinal section at any level of the uterus (fundus or anterior, posterior or lateral walls).

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition Patients With Recurrent Unexplained Pregnancy Loss
Intervention Other: Pelvic ultrasound both two dimensional and three dimentional
Study Groups/Cohorts
  • 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
    Intervention: 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
    Intervention: Other: Pelvic ultrasound both two dimensional and three dimentional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 11, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03054558
Other Study ID Numbers C111
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party sherine Hosny Mohamed Gad Allah, Cairo University
Study Sponsor sherine Hosny Mohamed Gad Allah
Collaborators Not Provided
Investigators
Principal Investigator: Sherine H Gad Allah, MD kasr al aini teaching hospital
PRS Account Cairo University
Verification Date April 2018