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Trial History Detail on 2016-04-12

CUHK_CCRB00506

2016-04-12

Prospective

HMRF 12131001

Health and Medical Research Fund, Food and Health Bureau

The Chinese University of Hong Kong

N/A

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

Min Whui Fong

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

22528722

minwhui@cuhk.edu.hk

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

Hong Kong

TSANG Katrina

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

22528784

ktsang@cuhk.edu.hk

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

Hong Kong

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

Hong Kong

紓緩分娩痛楚研究計劃

Labour pain study

Hong Kong

Yes

2014-06-08

Joint CUHK-NTEC Clinical Research Ethics Committee

2014.189-T

Maternal health

Pain relief

Labour

Pregnancy

Other

non-pharmacological

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.

N/A

N/A

At least 15 minutes

During labour

N/A

N/A

N/A

N/A

N/A

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

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

18

50

Female

Interventional

Randomized

Randomised intervention-control trial

Not Applicable

Single-blind

Trial subjects

Parallel

Other

Non-pharmacological study

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.

2016-04-17

960

Not Yet Recruiting

Pain intensity

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

Satisfaction with pain relief

Patient Outcome Questionnaire–Modified (APS-POQ Modified); b. Questions on willingness to use different analgesic methods in their next pregnancy and the most satisfied non-pharmacological method

Sense of control in labour

Chinese validated Labour Agentry Scale (c-LAS)

Satisfaction with childbirth experience

Six Simple Questions (SSQ)

Effect (negative) on mother-baby interaction

Validated Chinese version Postpartum Bonding Questionnaire (c-PBQ)

Breastfeeding

Data on the type of breastfeeding as defined by World Health Organization (WHO, (18)) is collected and the number of times per day in the 24-hour period preceding assessment

Assisted vaginal birth

Indications of vacuum extraction (VE) and forceps delivery (FD)

Caesarean section

Indication

Adverse effects

a. Maternal: perineal trauma (episiotomy or second or third degree tears requiring suturing); estimated blood loss; fever > 38 C; delayed hospital discharge; post-partum haemorrhage; abnormal blood pressure (high or low); need for labour augmentation; need for transfusion b. Infant: infection, dela

Admission to special care baby unit or neonatal intensive care unit

Indication and duration

Apgar score

Five-minute Apgar score less than seven

Infant outcomes at long-term follow-up

Medical problems such as neonatal jaundice, hospital re-admission, body length, body weight, developmental assessment by community nurse at 2-month visit.

Cost

Direct medical costs of pharmacological and hospitalisation utilisation. We will estimate cost using Hospital Authority (HA) unit price data or average market unit price where HA data is not available.

No

2016-09-14

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