WHO Fetal Growth Charts

Fetal Growth Complications Clinical Trial

Official title:

Implementation of WHO Fetal Growth Charts in Assiut,Egypt

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03755024
• Other study ID #: WHOFC
• Status: Not yet recruiting
• Start date: January 2019
• Est. completion date: May 2020

Study information

• Verified date: November 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: May 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Fetal Growth Complications

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of fetuses with abnormal fetal growth diagnosed using WHO fetal charts	correlation of fetal growth pattern with neonatal birth weight and outcome	8 months