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

Phase 2

Completed

• Conditions: Intrauterine Growth Restriction
• Interventions: Drug: Low dose aspirin; Drug: Omega 3

• Registration Number: NCT02696577
• Lead Sponsor: Assiut University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Study First Submitted: 2016-02-28
• Study First Submitted QC: 2016-02-28
• Status Verified: 2016-03
• Study First Posted: 2016-03-02
• Last Update Submitted: 2016-03-12
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose aspirin	Low dose aspirin	Received aspirin 81mg once daily for 6 weeks
Low dose aspirin plus omega 3 group	Low dose aspirin	Received aspirin 81mg and omega 3 once daily for 6 weeks.
Low dose aspirin plus omega 3 group	Omega 3	Received aspirin 81mg and omega 3 once daily for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Estimated fetal weight (gm)	1 year

Secondary Outcome Measures

Name	Time	Method
The changes in Doppler blood flow indices in both uterine arteries	1 year
Fetal weight at the time of delivery (gm) ,	1 year
Number of babies admitted to neonatal intensive care unit.	1 year
The changes in Doppler blood flow indices in umbilical artery	1 year

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt