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

Study Overview
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Brief Summary
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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

Conditions
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Intrauterine Growth Restriction

Intervention / Treatment
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* Drug: Low dose aspirin
* Drug: Omega 3


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose aspirin<br>Received aspirin 81mg once daily for 6 weeks | Drug: Low dose aspirin<br> <br> |
| Active Comparator: Low dose aspirin plus omega 3 group<br>Received aspirin 81mg and omega 3 once daily for 6 weeks. | Drug: Low dose aspirin<br> <br> Drug: Omega 3<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated fetal weight (gm) |  | 1 year | 

Secondary Outcome Measures

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