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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
Information provided by (Responsible Party):
Mohamed Ellaithy, Ain Shams University

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

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

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 ]

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

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

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

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

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Ain Shams University Recruiting
Abbasiya, Cairo, Egypt, 11566
Contact: Mohamed I. Ellaithy, M.D.    00201006873417    drmellisy@hotmail.com   
Sponsors and Collaborators
Ain Shams University
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Principal Investigator: Mohamed I Ellaithy, M.D. Ain Shams University
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Responsible Party: Mohamed Ellaithy, Lecturer of Obstetrics & Gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT01635426    
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:
Unexplained recurrent pregnancy loss
Uterine artery pulsatility index
Additional relevant MeSH terms:
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Abortion, Spontaneous
Fetal Death
Abortion, Habitual
Disease Attributes
Pathologic Processes
Pregnancy Complications
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents