Aspirin, Heparin and Miscarriage

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Khartoum
Sponsor:
Information provided by (Responsible Party):
Ishag Adam, University of Khartoum
ClinicalTrials.gov Identifier:
NCT01917799
First received: July 31, 2013
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in patients with a history of recurrent miscarriages.


Condition Intervention Phase
Pregnancy
Miscarriage
Drug: Aspirin
Drug: Heparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low Dose Aspirin and Low-molecular-weight Heparin in the Treatment of Pregnant Libyan Women With Recurrent Miscarriage

Resource links provided by NLM:


Further study details as provided by University of Khartoum:

Primary Outcome Measures:
  • Number of miscarriages [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To compare number of miscarriages between the two groups


Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aspirin
75mg tab of aspirin once daily
Drug: Aspirin
75mg tab of LDA once daily for 7 months
Other Name: LDA
Active Comparator: Aspirin + heparin
75mg tab of aspirin once daily + 0.4 mL/day of injection of low molecular weight heparin
Drug: Aspirin
75mg tab of LDA once daily for 7 months
Other Name: LDA
Drug: Heparin
0.4 mL/day of the Enoxaparin
Other Name: Enoxaparin

  Eligibility

Ages Eligible for Study:   15 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women
  • History of 2 or more of miscarriage

Exclusion Criteria:

  • Twins
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917799

Locations
Libyan Arab Jamahiriya
Misurata Teaching Hospital Recruiting
Misurata, Libyan Arab Jamahiriya, 218
Contact: Mohamed O Elmahashi, MD    +249911259199 ext -    essadifathi@hotmail.com   
Contact: Bashir M Ashur, MD    +249911259199 ext -    bmashur@yahoo.com   
Sponsors and Collaborators
University of Khartoum
  More Information

No publications provided by University of Khartoum

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ishag Adam, Professor, University of Khartoum
ClinicalTrials.gov Identifier: NCT01917799     History of Changes
Other Study ID Numbers: LDA and LMWH
Study First Received: July 31, 2013
Last Updated: August 6, 2013
Health Authority: Libya:Misurata Central Hospital

Keywords provided by University of Khartoum:
Aspirin
Heparin
pregnancy
miscarriage

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Aspirin
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anticoagulants

ClinicalTrials.gov processed this record on August 27, 2014