Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00513

2 Trial Registration Date

2016-05-20

i Registration Status

Prospective

3 Secondary IDs

2016.056

4 Source(s) of Funding

NA

5 Primary Sponsor

NA

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

DR. KONG WING SHAN

ii Address

1/F, SPECIAL BLOCK (BLOCK F), PRINCE WALES OF HOSPITAL, 30-32 NGAN SHING STREET , SHATIN, N.T., HONG KONG

iii Phone

2632 2996

iv Email

gracekong@cuhk.edu.hk

v Affiliation

principle investigator

vi Country

Hong Kong

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

i Name

Kong Wing Shan Grace

ii Address

1/F, SPECIAL BLOCK (BLOCK F), PRINCE WALES OF HOSPITAL, 30-32 NGAN SHING STREET , SHATIN, N.T., HONG KONG

iii Phone

26321537

iv Email

gracekong@cuhk.edu.hk

v Affiliation

Department of Obstetrics and Gynaecology

vi Country

Hong Kong

9 Official Scientific Title of the Study

The physical and psychological outcome of manual vacuum aspiration, expectant management, surgical evacuation or medical evacuation with single dose 800mcg vaginal misoprostol for women with first trimester miscarriage

10 Public Title

The physical and psychological outcome of manual vacuum aspiration, expectant management, surgical evacuation or medical evacuation with single dose 800mcg vaginal misoprostol for women with first trimester miscarriage

i Public Title in Chinese 研究名稱

手動式真空吸引術、保守治療、外科手術及單次陰道塞劑（misoprostol）對早孕期流產之婦女的生理及心理之影響

11 Short Title (Optional)

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?

2016-02-12

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.056

14 Medical Condition Being Studied

miscarriage

15 Intervention

i Types of intervention

Other

Please specify

This study only require participants to fill in questionnaires

ii Description/ name of Intervention/article

NA

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

NA

vi Frequency of the intervention

NA

16 Comparative Treatments

i Description/ name of comparative treatments

NA

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

Women who present with spontaneous miscarriage

ii Exclusion Criteria

severe blood loss

clinically presenting sepsis

patient refusal

iii Age Minimum

18

iv Age Maximum

50

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

This is not a drug trial

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-06-13

21 Target Sample Size

100

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

1. To assess the complete miscarriage rates and its complications of each treatment modalities

ii The metric or method of measurement used

questionnaires study

iii The timepoint(s) of primary interest

observe clinical outcome at the day of admission and 7 days, 14 days, 28 days and 6 months after miscarriage

24 Secondary Outcome

i The Name of the outcome

3. To assess the psychological outcomes of currently acceptable forms of treatment, with a focus the miscarrying woman’s experience

ii The metric or method of measurement used

questionnaire study

iii The timepoint(s) of primary interest

at the day of admission and 7 days, 14 days, 28 days and 6 months after miscarriage

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-07-06

27 Primary Registry and Trial Identifying Number

ChiCTR-OOC-16008511

28 Date of Registration in Primary Registry

2016-05-20

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Trial History Detail on 2016-09-02