Combined 3D Power Doppler Placental Volume and Vascular Flow Indices In the First Trimester of Pregnancy as Predictors Of Preeclampsia?.

Preeclampsia Clinical Trial

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?.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03399006
• Other study ID #: 19
• Status: Not yet recruiting
• Phase: N/A
• First received: January 8, 2018
• Last updated: January 8, 2018
• Start date: January 2018
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: Ahmed maged
• Phone: +20201005227404
• Email: dr_ahmedmaged08[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 1. Cases with fetal anomalies. 2. Dead fetuses

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Device:
• 2D ultrasound
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 Ultrasound
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 ultrasound
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.

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 to 38 weeks of gestational age