Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00168

2 Trial Registration Date

2008-08-28

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Kong Wing Shan Grace

ii Address

iii Phone

iv Email

e-mail gracekong@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Kong Wing Shan Grace

ii Address

iii Phone

iv Email

e-mail gracekong@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

The Physical and Psychological Outcomes of Expectant Management, Surgical Evacuation or Medical Evacuation with Single Dose 800 mcg Vaginal Misoprostol for Women with First Trimester Miscarriage in a Randomized Controlled Trial

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2008-08-11

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Women with first trimester miscarriage

15 Intervention

i Types of intervention

Other

Please specify

Drug & Procedure

ii Description/ name of Intervention/article

Expectant management, Surgical evacuation or Medical evacuation with single dose 800 mcg Misoprostol

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

2 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Expectant management, Surgical evacuation or Medical evacuation with single dose 800 mcg Misoprostol

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion Criteria: (i) ≥18 years old HK citizen (ii) Good past health; (iii) Gestation age ≤13 weeks; (iv) Ultrasound confirmed the diagnosis of miscarriage: (a) intrauterine gestational sac with mean sac diameter of ≥2cm without fetal pole; (b) presence of fetal pole with no cardiac pulsation; (c) the gestational sac was <2cm with no interval growth or persistent absence of fetal cardiac pulsation on rescanning 7 to 10 days later (v) Incomplete miscarriage which is supported by opened endocervical os and ultrasound findings of an endometrial echo showing mixed echogenicity.

ii Exclusion Criteria

Exclusion Criteria: (i) Women had complete miscarriage which was supported by an intrauterine dimension measuring <11cm2 (sagittal plus transverse plane) on ultrasound (ii) Severe blood loss, sepsis (iii) Known allergy to prostaglandin or their analogues (iv) Any reason that the attending clinician thinks that may make the patient unsuitable for misoprostol administration

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-09-01

21 Target Sample Size

180

22 Recruitment Status

Unknown

23 Primary Outcome

1. To assess the complete miscarriage rates and its complications of each treatment modalities 2. To determine the predictive factors for successful outcome of currently acceptable forms of treatment 3. To assess the acceptance and satisfaction of treatment 4. To assess the psychological outcomes of currently acceptable forms of treatment, with a focus the miscarrying woman's experience 5. To assess the women's preference of currently acceptable forms of treatment 6. To assess the psychological impact of father of pregnancy during treatment

24 Secondary Outcome

Nil

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-01-21

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000725

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2011-04-01