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

Assiut University

Status and phase: Completed; Phase 2

Conditions: Intrauterine Growth Restriction

Treatments: Drug: Omega 3; Drug: Low dose aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02696577

OIUGR

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Low dose aspirin

Active Comparator group

Description:

Received aspirin 81mg once daily for 6 weeks

Treatment:

Drug: Low dose aspirin

Low dose aspirin plus omega 3 group

Active Comparator group

Description:

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

Treatment:

Drug: Low dose aspirin

Drug: Omega 3