NCT02696577

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

February 28, 2016

Last Update Submit

March 12, 2016

Conditions

Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

  • Estimated fetal weight (gm)

    1 year

Secondary Outcomes (4)

  • The changes in Doppler blood flow indices in both uterine arteries

    1 year

  • The changes in Doppler blood flow indices in umbilical artery

    1 year

  • Fetal weight at the time of delivery (gm) ,

    1 year

  • Number of babies admitted to neonatal intensive care unit.

    1 year

Study Arms (2)

Low dose aspirin

ACTIVE COMPARATOR

Received aspirin 81mg once daily for 6 weeks

Drug: Low dose aspirin

Low dose aspirin plus omega 3 group

ACTIVE COMPARATOR

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

Drug: Low dose aspirinDrug: Omega 3

Interventions

Low dose aspirinDRUG
Low dose aspirinLow dose aspirin plus omega 3 group
Omega 3DRUG
Low dose aspirin plus omega 3 group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Asyut Governorate, 71111, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 28068596DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

AspirinDocosahexaenoic Acids

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 28, 2016

First Posted

March 2, 2016

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Locations

EG(1)