NCT01917799

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4 pregnancy

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

4.8 years

First QC Date

July 31, 2013

Last Update Submit

August 6, 2013

Conditions

PregnancyMiscarriage

Keywords

AspirinHeparinpregnancymiscarriage

Outcome Measures

Primary Outcomes (1)

  • Number of miscarriages

    To compare number of miscarriages between the two groups

    3 months

Study Arms (2)

Aspirin

EXPERIMENTAL

75mg tab of aspirin once daily

Drug: Aspirin

Aspirin + heparin

ACTIVE COMPARATOR

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

Drug: AspirinDrug: Heparin

Interventions

AspirinDRUG

75mg tab of LDA once daily for 7 months

Also known as: LDA
AspirinAspirin + heparin
HeparinDRUG

0.4 mL/day of the Enoxaparin

Also known as: Enoxaparin
Aspirin + heparin

Eligibility Criteria

Age15 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant women
  • History of 2 or more of miscarriage

You may not qualify if:

  • Twins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misurata Teaching Hospital

Misratah, Misurata, 218, Libya

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24405979DERIVED

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

AspirinHeparinEnoxaparin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsGlycosaminoglycansPolysaccharidesCarbohydratesHeparin, Low-Molecular-Weight

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 7, 2013

Study Start

January 1, 2009

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

LI(1)