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Trial History Detail on 2018-01-25

CUHK_CCRB00576

2018-01-10

Prospective

2017.007-T

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

nil

nil

Not Applicable

Cheung Wing Ching

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

9228 5312

cosycheung@cuhk.edu.hk

Department of O&G

Hong Kong

Dr. CHUNG Pui Wah, Jacqueline

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

35051537

jacquelinechung@cuhk.edu.hk

Department of OG

Hong Kong

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

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

Buscopan®用於手動真空抽吸引術的疼痛控制:隨機對照試驗

Hong Kong

Yes

2017-03-02

Joint CUHK-NTEC Clinical Research Ethics Committee

2017.007-T

miscarriage

Drug

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.

intravenous injection

1ml 20mg

once only

once only

normal saline

intravenous injection

1 ml

once only

once only

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

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

18

60

Female

Interventional

Randomized

double blinded

Placebo

Double-blind

Parallel

Other

Buscopan had been long used.

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

2018-01-30

100

Recruiting

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

questionnaire and stress biomarker

(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.

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

questionnaire and stress biomarker

(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.

No

2020-07-06

ChiCTR1800014590

2018-01-16

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