Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00506

2 Trial Registration Date

2016-04-12

i Registration Status

Prospective

3 Secondary IDs

HMRF 12131001

4 Source(s) of Funding

Health and Medical Research Fund, Food and Health Bureau

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Take on all the responsibilities of sponsorship jointly with the primary sponsor

Please specify

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

i Name

Min Whui Fong

ii Address

5/F, JC School of Public Health & Primary Care, Prince of Wales Hospital, Shatin

iii Phone

22528722

iv Email

minwhui@cuhk.edu.hk

v Affiliation

Division of Family Medicine & Primary Healthcare, JC School of Public Health & Primary Care

vi Country

Hong Kong

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

i Name

TSANG Katrina

ii Address

4/F, JC School of Public Health & Primary Care, Prince of Wales Hospital, Shatin

iii Phone

22528784

iv Email

ktsang@cuhk.edu.hk

v Affiliation

Division of Family Medicine & Primary Healthcare, JC School of Public Health & Primary Care

vi Country

Hong Kong

9 Official Scientific Title of the Study

Birth Ball for Pregnant Women in Labour - A Multi-Centre Randomised Controlled Trial

10 Public Title

Hong Kong

i Public Title in Chinese 研究名稱

紓緩分娩痛楚研究計劃

11 Short Title (Optional)

Labour pain study

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?

2014-06-08

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014.189-T

14 Medical Condition Being Studied

Maternal health

Pain relief

Labour

Pregnancy

15 Intervention

i Types of intervention

Other

Please specify

non-pharmacological

ii Description/ name of Intervention/article

Birth balls, also called fitball or swissball, are large (55 cm or 65 cm) that provide a soft surface for women to sit on or lean against while carrying out simple exercises.

Birth balls can provide women with direct physical pain relief by improving pelvic dimensions, mobility and foetal positioning. Concurrently, women’s psychosocial wellbeing can be enhanced when they take an active role in their own care, thereby promoting a sense of control of their care and body postures, balance and coordination. Additionally, women’s caregivers (professional and lay) can use birth balls as a tangible means to support women throughout labour and delivery.

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

At least 15 minutes

vi Frequency of the intervention

During labour

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Chinese women able to provide informed consent

Singleton pregnancy in cephalic presentation planned for vaginal birth

Gestational age of 37-42 weeks admitted into a single room in labour unit either in spontaneous active labour and second stage not imminent; or for induction of labour

Uncomplicated past obstetrical and antenatal history enabling them to be under independent midwifery care

ii Exclusion Criteria

Multiple pregnancy

Foetal malpresentation contraindicating vaginal delivery

Complicated pregnancy requiring close monitoring and restricted mobilization

History of caesarean delivery or caesarean delivery planned for this pregnancy

iii Age Minimum

18

iv Age Maximum

50

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomised intervention-control trial

ii Nature of control

Not Applicable

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

Non-pharmacological study

vi Study Objectives (Optional)

To evaluate the effectiveness, safety and harms of birth ball use by pregnant women in labour compared to treatment as usual group on important and relevant woman-centred pregnancy and childbirth outcomes.

20 Anticipated trial start date

2016-04-17

21 Target Sample Size

960

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Pain intensity

ii The metric or method of measurement used

Visual analogue scale (VAS) of a 10-cm horizontal line subdivided evenly with marks