NCT01635426

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.

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
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_2

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

March 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

5.8 years

First QC Date

July 4, 2012

Last Update Submit

March 9, 2017

Conditions

Recurrent Pregnancy Loss

Keywords

AspirinClopidogrelUnexplained recurrent pregnancy lossUterine artery pulsatility index

Outcome Measures

Primary Outcomes (1)

  • Improvement in uterine artery pulsatility index

    2 months

Secondary Outcomes (1)

  • Improvement in subendometrial blood flow

    2 month

Study Arms (2)

Aspirin

ACTIVE COMPARATOR
Drug: Aspirin

Clopidogrel

ACTIVE COMPARATOR
Drug: Clopidogrel

Interventions

AspirinDRUG

Aspirin 75 mg daily for 2 months after meals

Also known as: Acetylsalicylic Acid
Aspirin
ClopidogrelDRUG

Clopidogrel 75 mg daily for 2 months after meals

Also known as: Plavix
Clopidogrel

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Known hypersensitivity to any of study medication components.
  • Immunotherapy, endocrinotherapy, anticoagulant or anti-platelet management during the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Al ‘Abbāsīyah, Cairo Governorate, 11566, Egypt

RECRUITING

MeSH Terms

Interventions

AspirinClopidogrel

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mohamed I Ellaithy, M.D.

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa I. Ibrahem, M.D.

CONTACT

00201001955996mi_monem@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics & Gynecology

Study Record Dates

First Submitted

July 4, 2012

First Posted

July 9, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

EG(1)