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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-02-29

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

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Detailed Description

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Conditions

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Intrauterine Growth Restriction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low dose aspirin

Received aspirin 81mg once daily for 6 weeks

Group Type ACTIVE_COMPARATOR

Low dose aspirin

Intervention Type DRUG

Low dose aspirin plus omega 3 group

Received aspirin 81mg and omega 3 once daily for 6 weeks.

Group Type ACTIVE_COMPARATOR

Low dose aspirin

Intervention Type DRUG

Omega 3

Intervention Type DRUG

Interventions

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Low dose aspirin

Intervention Type DRUG

Omega 3

Intervention Type DRUG

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No