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

NCT03399006 | Unknown DMC

• 1 other identifier: 19
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Device: 2D ultrasound; Device: Doppler Ultrasound; Device: 3D ultrasound

Normal pregnancy

women with normal blood presure

Device: 2D ultrasound; Device: Doppler Ultrasound; Device: 3D ultrasound

Interventions

2D ultrasound DEVICE

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

Normal pregnancy; preeclampsia

Doppler Ultrasound DEVICE

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.

Normal pregnancy; preeclampsia

3D ultrasound DEVICE

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.

Normal pregnancy; preeclampsia

Eligibility Criteria

• Age: 18 Years - 39 Years
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women at risk factor of preeclampsia as women with singleton pregnancy especially at the extremes of reproductive age

You may qualify if:

• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ahmed Maged

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed maged

CONTACT

+20201005227404; dr_ahmedmaged08@kasralainy.edu.eg

ameer elsherief

CONTACT

ameerelsherief@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

EG (1)