The Effect of Omega 3 on Pregnancy Complicated by Asymmetrical Intrauterine Growth Restriction

Intrauterine Growth Restriction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696577
• Other study ID #: OIUGR
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2016
• Last updated: March 12, 2016
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Assiut Medical School Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

Intrauterine growth restriction is a common and complex obstetric problem. Intrauterine growth restriction is noted to affect approximately 10-15 % of pregnant women. Intrauterine growth restriction is diagnosed antenatal; however, some of these fetuses, especially if unscreened during pregnancy, may be detected only in the neonatal period. It is very important for obstetricians and perinatologists to identify growth restricted fetuses, because this fetal condition is associated with significant perinatal morbidity and mortality.

Omega 3 is composed of polyunsaturated fatty acids with a double bond at the third carbon atom from the end of the carbon chain. The fatty acids have two ends, the carboxylic acid end, which is considered the beginning of the chain, thus "alpha", and the methyl end, which is considered the "tail" of the chain, thus "omega." Omega3 improve fetal wellbeing by two mechanisms: Firstly, maternal and docosahexaenoic acid supplementation during pregnancy and lactation normalizes intrauterine growth restriction induced changes in adipose deposition and visceral PPARγ expression. Secondly, maternal docosahexaenoic acid supplementation increases serum adiponectin, as well as adipose expression of adiponectin and adiponectin receptors. Novel findings suggest that maternal docosahexaenoic acid supplementation normalize adipose dysfunction and promote adiponectin-induced improvements in metabolic function in intrauterine growth restriction

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age: from 20 - 35 years old.

• Pregnant from 30 week to 32 week gestation.

• Singleton pregnancy with asymmetrical intrauterine growth restriction .

• Normal uterine and umbilical Doppler indices at time of recruitment.

Exclusion Criteria:

• Multiple gestations.

• Hypertensive women.

• Premature rupture of membranes.

• Abnormal Doppler indices in the form of Doppler blood flow indices > 2 standard deviation , absent diastolic flow and lastly; reversed flow.

• Congenital fetal malformation.

• Pregnancy complicated by antepartum hemorrhage.

• Marked decrease in Amniotic fluid volume.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction

Intervention

Drug:
• Low dose aspirin

• Omega 3

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated fetal weight (gm)		1 year	Yes
Secondary	The changes in Doppler blood flow indices in both uterine arteries		1 year	Yes
Secondary	The changes in Doppler blood flow indices in umbilical artery		1 year	Yes
Secondary	Fetal weight at the time of delivery (gm) ,		1 year	Yes
Secondary	Number of babies admitted to neonatal intensive care unit.		1 year	Yes