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Trial record 88 of 251 for:    ASPIRIN AND low-dose aspirin

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

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


Condition or disease Intervention/treatment Phase
Intrauterine Growth Restriction Drug: Low dose aspirin Drug: Omega 3 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Low dose aspirin
Received aspirin 81mg once daily for 6 weeks
Drug: Low dose aspirin
Active Comparator: Low dose aspirin plus omega 3 group
Received aspirin 81mg and omega 3 once daily for 6 weeks.
Drug: Low dose aspirin
Drug: Omega 3



Primary Outcome Measures :
  1. Estimated fetal weight (gm) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. The changes in Doppler blood flow indices in both uterine arteries [ Time Frame: 1 year ]
  2. The changes in Doppler blood flow indices in umbilical artery [ Time Frame: 1 year ]
  3. Fetal weight at the time of delivery (gm) , [ Time Frame: 1 year ]
  4. Number of babies admitted to neonatal intensive care unit. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696577


Locations
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Egypt
Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02696577     History of Changes
Other Study ID Numbers: OIUGR
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Aspirin
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics