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WHO Fetal Growth Charts

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ClinicalTrials.gov Identifier: NCT03755024
Recruitment Status : Not yet recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
mina eshak tawfeek khalil, Assiut University

Brief Summary:
Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Ultrasound estimation of fetal weight before birth is today very widely used in clinical practice, and, while essential for the identification and management of high-risk pregnancies,the current reference ranges used worldwide are largely based on single populations from a few high-income countries and are therefore of uncertain general applicability.

Condition or disease Intervention/treatment
Fetal Growth Complications Device: ultrasound

Detailed Description:
Against this background, WHO made it a high priority to provide fetal growth charts for estimated fetal weight and common ultrasound biometric measurements intended for worldwide use. WHO study was conducted in 10 countries including Egypt (Assiut).The study showed that fetal growth differs significantly between countries. Growth was to a small extent influenced by maternal age, height, weight, and parity, and by fetal sex. The study suggested that these WHO charts for growth are more suitable for international use than those commonly applied today. However, the differences between countries, with maternal factors, and with fetal sex mean that these growth charts may need to be adjusted for local clinical use to increase their diagnostic and predictive performance. In our setting, we are using the charts built in the ultrasound machines based on studies done in western countries. So, it is prudent now to implement the WHO fetal growth charts in our setting

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Study Type : Observational
Estimated Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implementation of WHO Fetal Growth Charts in Assiut,Egypt
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Group/Cohort Intervention/treatment
normal group
fetuses with normal growth
Device: ultrasound

The compulsory ultrasound measurements to be obtained at all visits include the following biometrical parameters:

  • Biparietal diameter
  • Head circumference
  • Abdominal circumference
  • Femur length
  • Humerus length

Growth retardation group
fetuses with retarded growth
Device: ultrasound

The compulsory ultrasound measurements to be obtained at all visits include the following biometrical parameters:

  • Biparietal diameter
  • Head circumference
  • Abdominal circumference
  • Femur length
  • Humerus length




Primary Outcome Measures :
  1. Proportion of fetuses with abnormal fetal growth diagnosed using WHO fetal charts [ Time Frame: 8 months ]
    correlation of fetal growth pattern with neonatal birth weight and outcome



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pregnant women attending Antenatal care clinic of Women's Health Hospital, Faculty of Medicine, Assiut university.
Criteria

Inclusion Criteria:

  • They have body-mass index between 18-30;
  • They have a singleton pregnancy;
  • Their gestational age at entry is between 8+0 to 12+6 weeks based on last menstrual period.
  • They have no history of health, environmental or economic constraints likely to impede fetal growth; need for long-term medication (including fertility treatment); smoking currently or in the previous 6 months; recurrent miscarriage; and any previous baby delivered pre-term (<37 weeks) or with a birth weight <2,500g b. Exclusion criteria:
  • Multiple pregnancy
  • Congenital fetal malformation (cardiac, cerebral, renal malformations, etc.)
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Responsible Party: mina eshak tawfeek khalil, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03755024    
Other Study ID Numbers: WHOFC
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

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