Clinical trial NCT02696577: The Effect of Omega 3 on Pregnancy Complicated by Asymmetrical Intrauterine Growth Restriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intrauterine Growth Restriction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 68
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Estimated fetal weight (gm)
timeFrame: 1 year
Secondary outcomes:
measure: The changes in Doppler blood flow indices in both uterine arteries
timeFrame: 1 year
measure: The changes in Doppler blood flow indices in umbilical artery
timeFrame: 1 year
measure: Fetal weight at the time of delivery (gm) ,
timeFrame: 1 year
measure: Number of babies admitted to neonatal intensive care unit.
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
citation: Ali MK, Amin ME, Amin AF, Abd El Aal DEM. Evaluation of the effectiveness of low-dose aspirin and omega 3 in treatment of asymmetrically intrauterine growth restriction: A randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2017 Mar;210:231-235. doi: 10.1016/j.ejogrb.2017.01.002. Epub 2017 Jan 3.