Aspirin, Heparin and Miscarriage

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2013 by Ishag Adam, University of Khartoum.
Recruitment status was: Recruiting

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

History of Changes

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 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:

MedlinePlus related topics: Blood Thinners Miscarriage

Drug Information available for: Aspirin Heparin Heparin sodium

U.S. FDA Resources

Further study details as provided by Ishag Adam, University of Khartoum:

Primary Outcome Measures:

Number of miscarriages [ Time Frame: 3 months ]
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 (Child, Adult)
Sexes 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 essadifathi@hotmail.com
Contact: Bashir M Ashur, MD +249911259199 bmashur@yahoo.com

Sponsors and Collaborators

University of Khartoum

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Elmahashi MO, Elbareg AM, Essadi FM, Ashur BM, Adam I. Low dose aspirin and low-molecular-weight heparin in the treatment of pregnant Libyan women with recurrent miscarriage. BMC Res Notes. 2014 Jan 9;7:23. doi: 10.1186/1756-0500-7-23.


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

Keywords provided by Ishag Adam, University of Khartoum:


Aspirin Heparin pregnancy miscarriage

Additional relevant MeSH terms:


Abortion, Spontaneous Pregnancy Complications Aspirin Heparin Calcium heparin Heparin, Low-Molecular-Weight Dalteparin 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 Anticoagulants

ClinicalTrials.gov processed this record on July 21, 2017

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