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

A

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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