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Predictors of Intrauterine Growth Restriction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03349671
Recruitment Status : Unknown
Verified June 2018 by Ahmed Mohamed Abbas, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : November 21, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Study Description
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Brief Summary:

The main objectives of modern antenatal care programs are to identify high risk pregnancies then to predict any possibility of adverse pregnancy outcome as early as possible.

The earliest attempts to achieve this goal were possible with the introduction of ultrasound in obstetrical practice in the 1950s. A breakthrough that enabled obstetricians to directly visualize the fetus, placenta and amniotic fluid. At first 2-dimensional (2D) imaging was employed whereby fetal biometry and placental location were detected. Later on, Doppler measurements & 3-dimensional (3D) representation became feasible further revolutionizing this area


Condition or disease Intervention/treatment
Pre-Eclampsia Procedure: ultrasound

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Second Trimester Doppler Indices and Placental Vascularity as Predictors of Intrauterine Growth Restriction
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: ultrasound
    A 3D volume of the uterus will be acquired by transabdominal sonography. The sweep angle was set at 85º and the probe will be kept perpendicular to the placental plate. The placenta will be examined and the size of the volume box will be adapted in such a way that the placenta fitted into it completely. The volume will then stored for later offline analysis.

Outcome Measures
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Primary Outcome Measures :
  1. The rate of preeclampsia during pregnancy. [ Time Frame: 5 months ]
    number of women developed preeclampsia


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who meet the eligibility criteria of the study will be invited to participate and only those who will give agreement on the informed written consent.
Criteria

Inclusion Criteria:

  1. Pregnant female.
  2. Pregnant ± 22 to 26 weeks gestation
  3. Singleton pregnancy.
  4. Consenting to participate

Exclusion Criteria:

  1. Intrauterine fetal death
  2. Diagnosed to have Any congenital anomalies
  3. Symmetrical IUGR
  4. Established fetal compromise that necessitates delivery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349671


Contacts
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Contact: Ahmed Abbas, MD 1001655790 bmr90@hotmail.com

Locations
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Egypt
Assiut Faculty of Medicine
Assiut, Egypt
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03349671    
Other Study ID Numbers: IUGRPET
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
 Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes