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Aspirin in Asymmetrically Intrauterine Growth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03038607
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Brief Summary:

Intrauterine growth restriction refers to a fetus that has failed to get a specific measures by a gestational age. Asymmetric type of Intrauterine growth restriction is known by normal sized head with smaller abdomen.It is important to recognize the growth restricted fetuses, because these fetuses may have fetal or neonatal complications.

When blood flow is increased, the oxygen and nutrients will deliver good to the fetus. The role of low-dose aspirin therapy in management of intrauterine growth restriction is controversial. It has been used, in many studies, in prevention of intrauterine growth restriction especially in women at high risk of pre-eclampsia or obstetrical antiphospholipid syndrome.


Condition or disease Intervention/treatment Phase
Intrauterine Growth Restriction Asymmetrical Drug: Aspirin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Low-dose Aspirin on Fetal Weight of Idiopathic Asymmetrically Intrauterine Growth Restricted Fetuses With Abnormal Umbilical Doppler Indices
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Aspirin group Drug: Aspirin
This group were subjected to aspirin 75 mg once daily for 6 weeks.

No Intervention: No intervention



Primary Outcome Measures :
  1. Estimated fetal weight [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Birth weight [ Time Frame: 6 weeks ]
  2. Changes in Doppler blood flow indices in umbilical artery [ Time Frame: 6 weeks ]


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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:

  • The pregnant women
  • 28-30 weeks
  • Idiopathic asymmetrically intrauterine growth restriction
  • Middle aged women (20-35 years)
  • Women with abnormal umbilical artery Doppler flow indices ( > +2 standard deviation above mean for gestational age)

Exclusion Criteria:

  • Women less than 20 and more than 35 years
  • hypertensive or diabetic women
  • any type of smoking
  • multiple pregnancies
  • amniotic fluid index <5 cm
  • premature pre-labor rupture of membranes
  • abnormal placenta
  • any fetal congenital malformations.
  • women had absent diastolic flow or reversed flow in umbilical artery at the time of recruitment.

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): NCT03038607


Locations
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Egypt
Women Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University

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Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT03038607     History of Changes
Other Study ID Numbers: ASP
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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