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

• ClinicalTrials.gov Identifier: NCT03081754
• Recruitment Status: Completed
• First Posted: March 16, 2017
• Last Update Posted: March 16, 2017
• Sponsor: Ahmed Maged
• Information provided by (Responsible Party): Ahmed Maged, Cairo University

Study Description

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:

Condition or disease	Intervention/treatment
Intrauterine Growth Restriction	Radiation: Doppler velocimetry

  Show Detailed Description

Study Design

• Study Type: Observational
• Actual Enrollment: 75 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Study of Placental Bed of Growth Restricted Fetuses: Correlation of Doppler Velocimetries of Uterine and Umbilical Arteries With Placental Pathology
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: March 2017
• Actual Study Completion Date: March 2017

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; 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.
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; 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.

Outcome Measures

Primary Outcome Measures :

1. Doppler correlation with placental pathology [ Time Frame: at delivery ]

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes
• 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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

Egypt

Kasr Alainy medical school

Cairo, Egypt, 12151

Sponsors and Collaborators

Ahmed Maged

Investigators

• Principal Investigator: Ahmed Maged, MD; Kasr Alainy medical school

More Information

• Responsible Party: Ahmed Maged, Assistant professor, Cairo University
• ClinicalTrials.gov Identifier: NCT03081754 History of Changes
• Other Study ID Numbers: 160
• First Posted: March 16, 2017
• Last Update Posted: March 16, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Fetal Growth Retardation; Fetal Diseases; Pregnancy Complications; Growth Disorders; Pathologic Processes