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

Primary Purpose

Intrauterine Growth Restriction

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Low dose aspirin
Omega 3
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrauterine Growth Restriction

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low dose aspirin

Low dose aspirin plus omega 3 group

Arm Description

Received aspirin 81mg once daily for 6 weeks

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

Outcomes

Primary Outcome Measures

Estimated fetal weight (gm)

Secondary Outcome Measures

The changes in Doppler blood flow indices in both uterine arteries
The changes in Doppler blood flow indices in umbilical artery
Fetal weight at the time of delivery (gm) ,
Number of babies admitted to neonatal intensive care unit.

Full Information

First Posted
February 28, 2016
Last Updated
March 12, 2016
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02696577
Brief Title
The Effect of Omega 3 on Pregnancy Complicated by Asymmetrical Intrauterine Growth Restriction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Growth Restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose aspirin
Arm Type
Active Comparator
Arm Description
Received aspirin 81mg once daily for 6 weeks
Arm Title
Low dose aspirin plus omega 3 group
Arm Type
Active Comparator
Arm Description
Received aspirin 81mg and omega 3 once daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Low dose aspirin
Intervention Type
Drug
Intervention Name(s)
Omega 3
Primary Outcome Measure Information:
Title
Estimated fetal weight (gm)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The changes in Doppler blood flow indices in both uterine arteries
Time Frame
1 year
Title
The changes in Doppler blood flow indices in umbilical artery
Time Frame
1 year
Title
Fetal weight at the time of delivery (gm) ,
Time Frame
1 year
Title
Number of babies admitted to neonatal intensive care unit.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28068596
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.
Results Reference
derived

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

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