PreeclampsiaNCT03399006
Combined 3D Power Doppler Placental Volume and Vascular Flow Indices In the First Trimester of Pregnancy as Predictors Of Preeclampsia?.
An observational study of Preeclampsia, run by Cairo University at 1 site in Egypt.
Trial summary
200 women at risk factor for preeclampsia will be subjected to transabdominal Doppler ultrasonography for assessment of placental volume measurements, pulasatility index (PI) and resistivity index (RI) in both uterine arteries, and assessment of the placental volume and its vascular indices (VI, FI, VFI) Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- 2D ultrasound, Doppler Ultrasound and 3D ultrasound
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2018to Dec 2018
- 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 39 years
- Women only
- Adult
Study population: women at risk factor of preeclampsia as women with singleton pregnancy especially at the extremes of reproductive age
Who may be able to join
- 1. Singleton pregnancy. 2. Familial history of preeclampsia as it has agenetic predisposition. 3. Regular menstrual cycles before pregnancy. 4. Females had preeclampsia in a previous pregnancy. 5. Gestational diabetes or essential hypertension or chronic nephritis with pregnancy" they will be seen between 11 - 14 weeks' of gestation
Who cannot join
- 1. Cases with fetal anomalies. 2. Dead fetuses
Trial locations and contacts
1 site in 1 country.
ameer elsherief contact
About this study
Official title: Combined 3D Power Doppler Placental Volume and Vascular Flow Indices In the First Trimester of Pregnancy Could be a Specific Screening Toll in the Early Prediction Of Preeclampsia?.
200 women at risk factor for preeclampsia will be subjected to transabdominal Doppler ultrasonography for assessment of placental volume measurements, pulasatility index (PI) and resistivity index (RI) in both uterine arteries, and assessment of the placental volume and its vascular indices (VI, FI, VFI)
Read the detailed description
Ultrasonography assessment: Woman underwent an abdominal ultrasonographic examination including color-Doppler techniques at the period of 11-14 weeks of gestations to assess the following data:
- Gestational age was determined from the onset of the last normal menstrual period; measurements of fetal crown-rump length (CRL) were done to confirm the fetal gestational age.
- The fetal viability and careful search for any fetal abnormalities present.
- The measurement of the pulsatility index (PI), the resistance index (RI) in the uterine arteries both on the left and right side, detection for the presence of notch and determine whether it is unilateral or bilateral.
- The time of examination was approximately 20 minutes.
- The ultrasound equipment used for both abdominal sonography and color Doppler technique was GE ultrasound machine (model?? ) equipped with pulsed and color Doppler options was used with the probe frequency of 7 MHz.
Trans-abdominal ultrasound examination was performed with the woman placed in a recumbent or semi recumbent position \& carried out for measurement of fetal CRL and diagnosis of any major fetal defects and measurement of UtA-PI \& UtA-RI. A sagittal section of the uterus was obtained For the Doppler studies, and the cervical canal and internal cervical os were identified. The transducer was gently tilted from side to side and color flow mapping was used to identify each UtA along the side of the cervix and uterus at the level of the internal os.
the sampling gate set at 2mm to cover the whole vessel and care was taken to ensure that the angle of insonation was less than 60◦. When three similar consecutive waveforms had been obtained the UtA-PI and UtA-RI were measured, and the mean UtA-PI and UtA-RI of the left and right arteries were calculated.
Uterine artery Doppler was obtained with the patient in a semirecumbent position following a previously described technique [14]. A sagittal view of the uterus and of the cervical canal was obtained and color flow mapping was used to identify the uterine arteries coursing along the side of the cervix and uterus. The pulsed Doppler sample volume was placed on the ascending branch of the uterine artery closest to the internal os. The pulsatility index (PI = S _ D/M) was measured on three consecutive waveforms and the mean value between the left and right arteries was calculated. The presence of an early diastolic notch in the waveforms was recorded. An abnormal value was considered a mean PI greater than 2.36 corresponding to the 95th centile of a cross-sectional study on 3045 pregnancies
3D transabdominal ultrasound of the Placental volume: the transducer with a full bladder and the transducer placed perpendicular to the placenta to see the entire placenta. The adjustments to 3D placental scan were an angle of 70° and a maximum region of interest that allowed the full placental surface. The external limits of the placenta were defined by the basal plate and the chorionic plate excluding the myometrium. Another acquisition was done, if the quality criteria were not attained.
After sonography, the placental volume was calculated with 4D View software (GE Healthcare) by a single operator. The calculation was done twice using the same image, and the time spent was recorded. The VOCAL mode with an angle of rotation of 30° was chosen; the axial plane was the reference; and the calipers were placed on either side of the placenta. With 6 planes, it was possible to reconstruct the volume measured in cubic centimeters
- Conditions
- Preeclampsia
- Being tested
- 2D ultrasound, Doppler Ultrasound, 3D ultrasound
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D ultrasoundDevice
Trans-abdominal ultrasound examination was performed with the woman placed in a recumbent or semi recumbent position \& carried out for measurement of fetal CRL and diagnosis of any major fetal defects
Doppler UltrasoundDevice
measurement of UtA-PI \& UtA-RI. A sagittal section of the uterus was obtained For the Doppler studies, and the cervical canal and internal cervical os were identified. The transducer was gently tilted from side to side and color flow mapping was used to identify each UtA along the side of the cervix and uterus at the level of the internal os.
When three similar consecutive waveforms had been obtained the UtA-PI and UtA-RI were measured, and the mean UtA-PI and UtA-RI of the left and right arteries were calculated.
3D ultrasoundDevice
3D transabdominal ultrasound of the Placental volume: the transducer with a full bladder and the transducer placed perpendicular to the placenta to see the entire placenta. The adjustments to 3D placental scan were an angle of 70° and a maximum region of interest that allowed the full placental surface. The external limits of the placenta were defined by the basal plate and the chorionic plate excluding the myometrium. Another acquisition was done, if the quality criteria were not attained.
After sonography, the placental volume was calculated with 4D View software (GE Healthcare) by a single operator. The calculation was done twice using the same image, and the time spent was recorded. The VOCAL mode with an angle of rotation of 30° was chosen; the axial plane was the reference; and the calipers were placed on either side of the placenta. With 6 planes, it was possible to reconstruct the volume measured in cubic centimeters.
| Study group | Role | What they receive |
|---|---|---|
| preeclampsia | women who developed preeclampsia. Preeclampsia was defined as a blood pressure 140/90 mmHg and proteinuria of 300 mg in 24 hours, or two readings of at least 2+ on dipstick analysis of midstream urine specimens if no 24-hour urine collection was available in absence of urinary tract infection Receives: Device: 2D ultrasound; Device: Doppler Ultrasound; Device: 3D ultrasound | |
| Normal pregnancy | women with normal blood presure Receives: Device: 2D ultrasound; Device: Doppler Ultrasound; Device: 3D ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of preeclampsia
Preeclampsia was defined as a blood pressure 140/90 mmHg and proteinuria of 300 mg in 24 hours, or two readings of at least 2+ on dipstick analysis of midstream urine specimens if no 24-hour urine collection was available in absence of urinary tract infection
Measured: 28 to 38 weeks of gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study startJan 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399006
- Sponsor's protocol ID
- 19
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined 3D Power Doppler Placental Volume and Vascular Flow Indices In the First Trimester of Pregnancy Could be a Specific Screening Toll in the Early Prediction Of Preeclampsia?.
- ClinicalTrials.gov ID
- NCT03399006
- Acronym / sponsor ID
- 19
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Jan 2018 (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.
200 women at risk factor for preeclampsia will be subjected to transabdominal Doppler ultrasonography for assessment of placental volume measurements, pulasatility index (PI) and resistivity index (RI) in both uterine arteries, and assessment of the placental volume and its vascular indices (VI, FI, VFI)
Detailed description
Ultrasonography assessment: Woman underwent an abdominal ultrasonographic examination including color-Doppler techniques at the period of 11-14 weeks of gestations to assess the following data:
- Gestational age was determined from the onset of the last normal menstrual period; measurements of fetal crown-rump length (CRL) were done to confirm the fetal gestational age.
- The fetal viability and careful search for any fetal abnormalities present.
- The measurement of the pulsatility index (PI), the resistance index (RI) in the uterine arteries both on the left and right side, detection for the presence of notch and determine whether it is unilateral or bilateral.
- The time of examination was approximately 20 minutes.
- The ultrasound equipment used for both abdominal sonography and color Doppler technique was GE ultrasound machine (model?? ) equipped with pulsed and color Doppler options was used with the probe frequency of 7 MHz.
Trans-abdominal ultrasound examination was performed with the woman placed in a recumbent or semi recumbent position \& carried out for measurement of fetal CRL and diagnosis of any major fetal defects and measurement of UtA-PI \& UtA-RI. A sagittal section of the uterus was obtained For the Doppler studies, and the cervical canal and internal cervical os were identified. The transducer was gently tilted from side to side and color flow mapping was used to identify each UtA along the side of the cervix and uterus at the level of the internal os.
the sampling gate set at 2mm to cover the whole vessel and care was taken to ensure that the angle of insonation was less than 60◦. When three similar consecutive waveforms had been obtained the UtA-PI and UtA-RI were measured, and the mean UtA-PI and UtA-RI of the left and right arteries were calculated.
Uterine artery Doppler was obtained with the patient in a semirecumbent position following a previously described technique [14]. A sagittal view of the uterus and of the cervical canal was obtained and color flow mapping was used to identify the uterine arteries coursing along the side of the cervix and uterus. The pulsed Doppler sample volume was placed on the ascending branch of the uterine artery closest to the internal os. The pulsatility index (PI = S _ D/M) was measured on three consecutive waveforms and the mean value between the left and right arteries was calculated. The presence of an early diastolic notch in the waveforms was recorded. An abnormal value was considered a mean PI greater than 2.36 corresponding to the 95th centile of a cross-sectional study on 3045 pregnancies
3D transabdominal ultrasound of the Placental volume: the transducer with a full bladder and the transducer placed perpendicular to the placenta to see the entire placenta. The adjustments to 3D placental scan were an angle of 70° and a maximum region of interest that allowed the full placental surface. The external limits of the placenta were defined by the basal plate and the chorionic plate excluding the myometrium. Another acquisition was done, if the quality criteria were not attained.
After sonography, the placental volume was calculated with 4D View software (GE Healthcare) by a single operator. The calculation was done twice using the same image, and the time spent was recorded. The VOCAL mode with an angle of rotation of 30° was chosen; the axial plane was the reference; and the calipers were placed on either side of the placenta. With 6 planes, it was possible to reconstruct the volume measured in cubic centimeters
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preeclampsia | – | Device: 2D ultrasound, Device: Doppler Ultrasound, Device: 3D ultrasoundwomen who developed preeclampsia. Preeclampsia was defined as a blood pressure 140/90 mmHg and proteinuria of 300 mg in 24 hours, or two readings of at least 2+ on dipstick analysis of midstream urine specimens if no 24-hour urine collection was available in absence of urinary tract infection |
| Normal pregnancy | – | Device: 2D ultrasound, Device: Doppler Ultrasound, Device: 3D ultrasoundwomen with normal blood presure |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- women at risk factor of preeclampsia as women with singleton pregnancy especially at the extremes of reproductive age
Key inclusion criteria (1 listed)
- 1. Singleton pregnancy. 2. Familial history of preeclampsia as it has agenetic predisposition. 3. Regular menstrual cycles before pregnancy. 4. Females had preeclampsia in a previous pregnancy. 5. Gestational diabetes or essential hypertension or chronic nephritis with pregnancy" they will be seen between 11 - 14 weeks' of gestation
Key exclusion criteria (1 listed)
- 1. Cases with fetal anomalies. 2. Dead fetuses
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 |
|---|---|---|
| 2D ultrasoundTrans-abdominal ultrasound examination was performed with the woman placed in a recumbent or semi recumbent position \& carried out for measurement of fetal CRL and diagnosis of any major fetal defects | Device | Normal pregnancy, preeclampsia |
| Doppler Ultrasoundmeasurement of UtA-PI \& UtA-RI. A sagittal section of the uterus was obtained For the Doppler studies, and the cervical canal and internal cervical os were identified. The transducer was gently tilted from side to side and color flow mapping was used to identify each UtA along the side of the cervix and uterus at the level of the internal os. When three similar consecutive waveforms had been obtained the UtA-PI and UtA-RI were measured, and the mean UtA-PI and UtA-RI of the left and right arteries were calculated. | Device | Normal pregnancy, preeclampsia |
| 3D ultrasound3D transabdominal ultrasound of the Placental volume: the transducer with a full bladder and the transducer placed perpendicular to the placenta to see the entire placenta. The adjustments to 3D placental scan were an angle of 70° and a maximum region of interest that allowed the full placental surface. The external limits of the placenta were defined by the basal plate and the chorionic plate excluding the myometrium. Another acquisition was done, if the quality criteria were not attained. After sonography, the placental volume was calculated with 4D View software (GE Healthcare) by a single operator. The calculation was done twice using the same image, and the time spent was recorded. The VOCAL mode with an angle of rotation of 30° was chosen; the axial plane was the reference; and the calipers were placed on either side of the placenta. With 6 planes, it was possible to reconstruct the volume measured in cubic centimeters. | Device | Normal pregnancy, preeclampsia |
Primary outcome
Development of preeclampsia
Time frame: 28 to 38 weeks of gestational age
Preeclampsia was defined as a blood pressure 140/90 mmHg and proteinuria of 300 mg in 24 hours, or two readings of at least 2+ on dipstick analysis of midstream urine specimens if no 24-hour urine collection was available in absence of urinary tract infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
ameer elsherief contact
Ahmed Maged principal investigator
Professor
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 Preeclampsia, run by Cairo University 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 1 inclusion and 1 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 16 Jan 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 Ahmed maged (+20201005227404, dr_ahmedmaged08@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of preeclampsia (time frame: 28 to 38 weeks of gestational age). 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 16 Jan 2018.