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

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ClinicalTrials.gov Identifier: NCT02696577
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Tracking Information
First Submitted Date  ICMJE February 28, 2016
First Posted Date  ICMJE March 2, 2016
Last Update Posted Date March 15, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2016)
Estimated fetal weight (gm) [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02696577 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2016)
  • The changes in Doppler blood flow indices in both uterine arteries [ Time Frame: 1 year ]
  • The changes in Doppler blood flow indices in umbilical artery [ Time Frame: 1 year ]
  • Fetal weight at the time of delivery (gm) , [ Time Frame: 1 year ]
  • Number of babies admitted to neonatal intensive care unit. [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Omega 3 on Pregnancy Complicated by Asymmetrical Intrauterine Growth Restriction
Official Title  ICMJE Not Provided
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intrauterine Growth Restriction
Intervention  ICMJE
  • Drug: Low dose aspirin
  • Drug: Omega 3
Study Arms  ICMJE
  • Active Comparator: Low dose aspirin
    Received aspirin 81mg once daily for 6 weeks
    Intervention: Drug: Low dose aspirin
  • Active Comparator: Low dose aspirin plus omega 3 group
    Received aspirin 81mg and omega 3 once daily for 6 weeks.
    Interventions:
    • Drug: Low dose aspirin
    • Drug: Omega 3
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2016)
68
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02696577
Other Study ID Numbers  ICMJE OIUGR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Mohammed Khairy Ali, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP