Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00408

2 Trial Registration Date

2014-04-23

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.533

4 Source(s) of Funding

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

5 Primary Sponsor

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

6 Secondary Sponsor

Nil

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

TSE Lai Yiu

ii Address

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

iii Phone

26321764

iv Email

eristse@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. Grace Wing Shan KONG

ii Address

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

iii Phone

26322996

iv Email

gracekong@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong

9 Official Scientific Title of the Study

A pilot study of thrombophilia among Chinese women with Recurrent miscarriage

10 Public Title

A pilot study of thrombophilia among Chinese women with Recurrent miscarriage

i Public Title in Chinese 研究名稱

慣性流產與血柱傾向疾之關係研究

11 Short Title (Optional)

Thrombophilia in Chinese recurrent miscarriage

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-03-26

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2013.533

14 Medical Condition Being Studied

women with recurrent miscarriage

15 Intervention

i Types of intervention

Other

Please specify

na

ii Description/ name of Intervention/article

This study will involve 15 ml blood taking for thrombophilic screening

iii Dosage form of the intervention

na

iv Dosage of the intervention

na

v Duration of the intervention

This study will involve 15 ml blood taking for the blood assay

vi Frequency of the intervention

once

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

Na

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1) clinical history of at least three early (<12 weeks of gestation) consecutive pregnancy losses; 2) aged between 18 and 40 years; 3) absence of any chromosomal, endocrine, infectious, anatomic, and autoimmune causes for recurrent miscarriage

ii Exclusion Criteria

Presence of any chromosomal, endocrine, infectious, anatomic, and autoimmune causes for recurrent miscarriage; Incompetence or refuse for informed consent.

iii Age Minimum

18

iv Age Maximum

40

v Gender

Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-06-01

21 Target Sample Size

100

22 Recruitment Status

Recruiting

23 Primary Outcome

prevalence of various thrombophillia among the Chinese women with recurrent miscarriage.During 1st visit in our study

24 Secondary Outcome

Result of Protein C, Protein S, Antithrombin III, Lupus anticoagulant and anticardiolipin antibody assay;
Result of Activated protein C resistance assay; Result of Factor V mutation, prothrombin gene mutation and 5,10-methylenetetrahydrofolate reductase genes mutation

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-06-05

27 Primary Registry and Trial Identifying Number

ChiCTR-OCS-14004560

28 Date of Registration in Primary Registry

2014-04-24

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Trial History Detail on 2016-07-13