Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00576

2 Trial Registration Date

2018-01-10

i Registration Status

Prospective

3 Secondary IDs

2017.007-T

4 Source(s) of Funding

Department of Obstetrics and Gynaecology, CUHK and health and medical research fund

5 Primary Sponsor

nil

6 Secondary Sponsor

nil

Function

Not Applicable

Please specify

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

i Name

LEE Hiu Tan, Margaret

ii Address

office 4, 1F, Block E, Department of O&G, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, N.T. Hong Kong

iii Phone

35051764

iv Email

margaretlee@cuhk.edu.hk

v Affiliation

Department of O&G

vi Country

Hong Kong

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

i Name

Dr. CHUNG Pui Wah, Jacqueline

ii Address

1/F, Block E, Department of O&G, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, N.T. Hong Kong

iii Phone

35051537

iv Email

jacquelinechung@cuhk.edu.hk

v Affiliation

Department of OG

vi Country

Hong Kong

9 Official Scientific Title of the Study

Buscopan® for pain control in manual vacuum aspiration (MVA): A randomized controlled trial

10 Public Title

Buscopan® for pain control in manual vacuum aspiration (MVA): A randomized controlled trial

i Public Title in Chinese 研究名稱

Buscopan®用於手動真空抽吸引術的疼痛控制：隨機對照試驗

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?

2017-03-02

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.007-T

14 Medical Condition Being Studied

miscarriage

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Buscopan® (Hyoscine-N-Butylbromide, Boehringer In-gelheim, Berkshire, UK) is an anti-spasmodic drug which is used to relieve the spams from genitourinary system . It has been available more than 60 years and large placebo controlled demonstrated that it is beneficial in relieving discomfort associated with cramping. Moreover, it only act locally and does not cross blood brain barrier which indicate that the systemic anticholinergic adverse event is very low.

iii Dosage form of the intervention

intravenous injection

iv Dosage of the intervention

1ml 20mg

v Duration of the intervention

once only

vi Frequency of the intervention

once only

16 Comparative Treatments

i Description/ name of comparative treatments

normal saline

ii Dosage form of the comparative treatments

intravenous injection

iii Dosage of the comparative treatments

1 ml

iv Duration of the comparative treatments

once only

v Frequency of the comparative treatments

once only

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Women 18 years old or above

first trimester miscarriage

No fetal heart beat in those with CRL 25mm

incomplete miscarriage with POG <5cm

hemodynamically stable

tolerates well with speculum examination

ii Exclusion Criteria

cervical stenosis

fibroid uterus >12 weeks in size

known uterine malformation

bleeding disorder

clinically sepsis

inability to tolerate pelvic examination

History of allergy to misprostol, Buscopan® or same group of drug

Contraindication to the use of Buscopan®

Unable to follow instruction to have saliva sampling

History of psychological/ psychiatric problem

History of smoking, physical exercise, meals, alcoholic beverages and low pH drinks at least 1 hour prior to saliva sampling

iii Age Minimum

18

iv Age Maximum

60

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

double blinded

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

Buscopan had been long used.

vi Study Objectives (Optional)

To investigate the effectiveness of the effectiveness Buscopan® via structured questionnaire and stress biomarker throughout the MVA procedure.

20 Anticipated trial start date

2018-01-30

21 Target Sample Size

122

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

To investigate the use of Buscopan in reducing pain level during MVA procedure

ii The metric or method of measurement used

questionnaire and stress biomarker

iii The timepoint(s) of primary interest

(1) take 10 minutes to fill in questionnaires (2) provide saliva samples for salivary alpha amylase (sAA) analysis in the following time point: (a) before MVA procedure, (b) immediately after MVA, (c) every 10 mins after MVA for 30 mins.

24 Secondary Outcome

i The Name of the outcome

To investigate the use of Buscopan in reducing stress level during MVA procedure

ii The metric or method of measurement used

questionnaire and stress biomarker

iii The timepoint(s) of primary interest

(1) take 10 minutes to fill in questionnaires (2) provide saliva samples for salivary alpha amylase (sAA) analysis in the following time point: (a) before MVA procedure, (b) immediately after MVA, (c) every 10 mins after MVA for 30 mins.

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

ChiCTR1800014590

28 Date of Registration in Primary Registry

2018-01-16

Back History

Trial Detail