Patients With Recurrent Unexplained Pregnancy LossJZNCT03054558
JZ Thickness as a Predictor of Recurrent Unexplained First Trimesteric Pregnancy Loss.
An observational study of Patients With Recurrent Unexplained Pregnancy Loss, run by sherine Hosny Mohamed Gad Allah at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Patients With Recurrent Unexplained Pregnancy Loss
- What is being tested?
- Pelvic ultrasound both two dimensional and three dimentional
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2015to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- Females with history of recurrent pregnancy loss
- for control group healthy females with history of at least one uncomplicated full pregnancy.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr AlAini teaching hospital
Cairo, 1243
Sherine H Gad Allah, MD, 01097665573 ext. +2, sherinehosny@gmail.com
About this study
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.
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.
Read the 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).
- Being tested
- Pelvic ultrasound both two dimensional and three dimentional
- Keywords
- Junctional zone, recurrent pregnancy loss, 3D power Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic ultrasound both two dimensional and three dimentionalOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Pelvic ultrasound both two dimensional and three dimentional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of junctional zone
Measured in coronal view of 3DTVS
Measured: immediatly measured by 3D TVS
Secondary outcomes (3)
Uterine artery Doppler Indices
measuring uterine artery pulsativity index (PI)
Measured: immediatly measured by 2D power Doppler TVS
Subendometrial blood flow
Measuring flow index (FI) ,vascularization index(VI) and vascularization flow index(VFI)
Measured: immediatly measured by 3d power Doppler TVS
Endometrial thickness
measuring endometrial thickness by 2d TVS (longitudinal view)
Measured: immediatly measured by 2D power Doppler TVS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startDec 2015
- Primary completionDec 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Recurrent Unexplained Pregnancy LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- sherine Hosny Mohamed Gad Allah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sherine Hosny Mohamed Gad Allah, Cairo University
- Investigators
- Sherine H Gad Allah, MD, Principal investigator, kasr al aini teaching hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054558
- Sponsor's protocol ID
- C111
- Acronym
- JZ
- Status last verified
- Apr 2018
- First submitted
- 11 Feb 2017
- Last updated
- 10 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03054558
- Acronym / sponsor ID
- JZ / C111
- Keywords
- Junctional zone, recurrent pregnancy loss, 3D power Doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- sherine Hosny Mohamed Gad AllahUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with recurrent unexplained pregnancy loss | – | Other: Pelvic ultrasound both two dimensional and three dimentionalPatients 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 |
| Healthy fertile patients | – | Other: Pelvic ultrasound both two dimensional and three dimentionalHealthy fertile patients with no history of previous miscarriage and have at least one uncomplicated pregnancy with no pelvic pathology |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- Females with history of recurrent pregnancy loss
- for control group healthy females with history of at least one uncomplicated full pregnancy.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic ultrasound both two dimensional and three dimentional | Other | Healthy fertile patients, patients with recurrent unexplained pregnancy loss |
Primary outcome
Thickness of junctional zone
Time frame: immediatly measured by 3D TVS
Measured in coronal view of 3DTVS
3 secondary outcomes
Uterine artery Doppler Indices
Time frame: immediatly measured by 2D power Doppler TVS
Subendometrial blood flow
Time frame: immediatly measured by 3d power Doppler TVS
Endometrial thickness
Time frame: immediatly measured by 2D power Doppler TVS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherine H Gad Allah, MD principal investigator
kasr al aini teaching hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Recurrent Unexplained Pregnancy Loss, run by sherine Hosny Mohamed Gad Allah at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherine H Gad Allah, MD (01097665573 ext. +2, sheribehosny@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of junctional zone (time frame: immediatly measured by 3D TVS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.