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Aspirin Versus Clopidogrel Effect on Uterine Blood Flow in Women With Unexplained Recurrent Miscarriages

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ClinicalTrials.gov Identifier: NCT01635426
Recruitment Status : Unknown
Verified March 2017 by Mohamed Ellaithy, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : July 9, 2012
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Ellaithy, Ain Shams University

Study Description
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Brief Summary:

The study will compare the effect of Aspirin versus clopidogrel effect on uterine perfusion in women with unexplained recurrent pregnancy loss with decreased uterine artery pulsatility index.

Null hypothesis: Women with recurrent miscarriage have the same blood flow after aspirin or clopidogrel treatment compared to their uterine artery pulsatility index before treatment.


Condition or disease Intervention/treatment Phase
Recurrent Pregnancy Loss Drug: Aspirin Drug: Clopidogrel Phase 2 Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Aspirin Versus Clopidogrel Effect on Uterine Perfusion in Women With Unexplained Recurrent Pregnancy Loss With Decreased Uterine Artery Pulsatility Index: A Randomized Controlled Trial
Study Start Date : March 2012
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Aspirin Drug: Aspirin
Aspirin 75 mg daily for 2 months after meals
Other Name: Acetylsalicylic Acid
Active Comparator: Clopidogrel Drug: Clopidogrel
Clopidogrel 75 mg daily for 2 months after meals
Other Name: Plavix


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in uterine artery pulsatility index [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Improvement in subendometrial blood flow [ Time Frame: 2 month ]

Eligibility Criteria
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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:

  • Women aged between 20 to 38 years old.
  • Regular menstrual cycle (26 to 33 days).
  • Women with 2 or more previous unexplained first trimester miscarriage.
  • Impaired uterine perfusion (PI of uterine artery more than 2.5).

Exclusion Criteria:

  • Known hypersensitivity to any of study medication components.
  • Immunotherapy, endocrinotherapy, anticoagulant or anti-platelet management during the past 3 months
Contacts and Locations
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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): NCT01635426


Contacts
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Contact: Mostafa I. Ibrahem, M.D. 00201001955996 mi_monem@yahoo.com

Locations
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Egypt
Ain Shams University Recruiting
Abbasiya, Cairo, Egypt, 11566
Contact: Mohamed I. Ellaithy, M.D.    00201006873417    drmellisy@hotmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Mohamed I Ellaithy, M.D. Ain Shams University
More Information
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Responsible Party: Mohamed Ellaithy, Lecturer of Obstetrics & Gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT01635426     History of Changes
Other Study ID Numbers: ASUOGRCT976
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by Mohamed Ellaithy, Ain Shams University:
Aspirin
Clopidogrel
Unexplained recurrent pregnancy loss
Uterine artery pulsatility index

Additional relevant MeSH terms:
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Abortion, Spontaneous
Fetal Death
Abortion, Habitual
Pregnancy Complications
Death
Pathologic Processes
Aspirin
Clopidogrel
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
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents