Aspirin, Heparin and Miscarriage

NCT ID: NCT01917799

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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Conditions

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Pregnancy Miscarriage

Keywords

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Aspirin Heparin pregnancy miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aspirin

75mg tab of aspirin once daily

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

75mg tab of LDA once daily for 7 months

Aspirin + heparin

75mg tab of aspirin once daily + 0.4 mL/day of injection of low molecular weight heparin

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

75mg tab of LDA once daily for 7 months

Heparin

Intervention Type DRUG

0.4 mL/day of the Enoxaparin

Interventions

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Aspirin

75mg tab of LDA once daily for 7 months

Intervention Type DRUG

Heparin

0.4 mL/day of the Enoxaparin

Intervention Type DRUG

Other Intervention Names

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LDA Enoxaparin

Eligibility Criteria

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Inclusion Criteria

* Pregnant women
* History of 2 or more of miscarriage

Exclusion Criteria

* Twins
Minimum Eligible Age

15 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Khartoum

OTHER

Sponsor Role lead

Responsible Party

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Ishag Adam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Misurata Teaching Hospital

Misratah, Misurata, Libya

Site Status RECRUITING

Countries

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Libya

Facility Contacts

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Mohamed O Elmahashi, MD

Role: primary

Bashir M Ashur, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 24405979 (View on PubMed)

Other Identifiers

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LDA and LMWH

Identifier Type: -

Identifier Source: org_study_id