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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02696577
Other study ID # OIUGR
Secondary ID
Status Completed
Phase Phase 2
First received February 28, 2016
Last updated March 12, 2016
Start date March 2015
Est. completion date February 2016

Study information

Verified date March 2016
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority Egypt: Assiut Medical School Ethical Review Board
Study type Interventional

Clinical Trial 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 PPARĪ³ 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


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date February 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Low dose aspirin

Omega 3


Locations

Country Name City State
Egypt Assiut university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estimated fetal weight (gm) 1 year Yes
Secondary The changes in Doppler blood flow indices in both uterine arteries 1 year Yes
Secondary The changes in Doppler blood flow indices in umbilical artery 1 year Yes
Secondary Fetal weight at the time of delivery (gm) , 1 year Yes
Secondary Number of babies admitted to neonatal intensive care unit. 1 year Yes
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