Correlation of Uterine and Umbilical Arteries Doppler With Placental Pathology in IUGR

NCT03081754 | Completed DMC

• 1 other identifier: 160
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

When indicated, a conservative management plan of IUGR was undertaken. Doppler studies were performed within the last week before delivery The results of Umbilical artery (UA) Doppler velocimetry were categorized as normal , increased , absent, and reversed . Patients were admitted for close surveillance in the case of worsening of maternal or fetal conditions (e.g. absent or reversed UA blood flow, and severe preeclampsia). Tissue samples The general shapes of placentas were assessed. The collected placentas were weighed by trimming the membranes and umbilical cord. Then the diameters and thickness of placentas were noted. The position of insertion of umbilical cord on the fetal surface of placenta was observed. Transverse cuts were made through the maternal surface at a distance of 1-2 cm in bread loaf manner and examined for the pale areas. All placentas were immersed in 10% formalin overnight and examined on the next day. For each placenta, blocks containing cord, membrane and full thickness of villous tissue were prepared. Whole thickness villous tissue blocks were obtained from three zones, i)central zone ii) peripheral zone and iii) intermediate zone between the first two zones, so as to include all areas of placenta. Placental bed biopsies were obtained at Caesarean sections with direct visualization of the placental site. Biopsies of at least 1cm were taken. The specimens were fixed in buffered formalin. The tissues were processed and stained with Haematoxlyin and Eosin. Microscopic study of placenta was carried out utilizing a set of standard criteria for villous and intervillous lesions Immunohistochemistry Expression of VEGF and CD34 was analyzed in 75 (50 placenta of IUGR and 25 of control) placental villous tissues. Immunostaining was performed by the streptavidin-biotin-peroxidase method. Evaluation of immunohistochemical staining To determine the MVD, the stained placental vasculature. Tissue sections were initially screened microscopically at low power (100×) to identify the areas of highest vascularization ("hot spots"). Evaluation of immunohistochemical staining of VEGF:

Conditions

Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

• Doppler correlation with placental pathology

  at delivery

Study Arms (2)

IUGR

Fifty women with intrauterine growth restricted fetuses were included in the study. Gestational age was based on the precisely dated last menstrual period and ultra-sonographic examination of crown-rump length in the first trimester. Intrauterine growth restriction was diagnosed when fetal abdominal circumference was more than two standard deviations below the mean for gestational age and also confirmed by the serial assessment of the fetal growth parameters (Chitty and Altman, 1999). Detailed obstetric history was available for each patient. Caesarean sections were performed on clinical grounds

Radiation: Doppler velocimetry

control group

Twenty five uneventful pregnancies with appropriate for gestational age fetuses are selected as control. Obstetric history Doppler results and placenta were examined for any remarkable pathology. Caesarean sections were performed on clinical grounds. The indications for Caesarean section of the controls, which were tried to be at equivalent gestational ages with the study group, were presentation abnormalities or previous Caesarean section

Radiation: Doppler velocimetry

Interventions

Doppler velocimetry RADIATION

Doppler studies were performed within the last week before delivery using a 3.5-Mhz transducer, all measurements were performed with the mothers in a semi recumbent position. Color-flow imaging was used to visualize the ascending branch of the uterine arteries. Pulsed Doppler velocimetry was performed with a sample volume of 5 mm.

IUGR; control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

1. Group 1 ( control group) : Twenty five uneventful pregnancies with appropriate for gestational age fetuses are selected as control. 2. Group 2: Fifty women with intrauterine growth restricted fetuses were included in the study. Gestational age was based on the precisely dated last menstrual period and ultra-sonographic examination of crown-rump length in the first trimester. Caesarean sections were performed on clinical grounds

You may qualify if:

• Pregnant women with gestational age 28-34 weeks fetal growth below 5th percentile

You may not qualify if:

• Pregnancies with known vascular maternal disease (chronic hypertension, autoimmune diseases, and diabetes) fetuses with structural abnormalities twins

Sponsors & Collaborators

• Ahmed Maged: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, Cairo Governorate, 12151, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The general shapes of placentas were assessed and weightedby trimming the membranes and umbilical cord. The diameters and thickness of placentas were noted cord insertion site. The maternal surface at a distance of 1-2 cm in bread loaf manner and examined for the pale areas. Whole thickness villous tissue blocks were obtained from three zones ;central, peripheral and intermediate zones Placental bed biopsies were obtained at Caesarean sections .. The specimens were fixed in buffered formalin. The tissues were processed and stained with Haematoxlyin and Eosin. Microscopic study of placenta was carried out utilizing a set of standard criteria for villous and intervillous lesions . For studying these criteria 8 random microscopic fields were chosen and 100 villi were counted in each field

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Laser-Doppler Flowmetry

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Rheology; Investigative Techniques

Study Officials

• Ahmed Maged, MD

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 16, 2017
• Study Start: January 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)