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Trial History Detail on 2017-10-16

CUHK_CCRB00525

2016-09-02

Prospective

2016.332

No

No

No

Not Applicable

Lai Chit Ying

1E office, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, 32 Ngan Shing Street, Shatin, Hong Kong

+852 35052258

cylai@cuhk.edu.hk

Department of Obstetrics and Gynaecology, Chinese University of Hong Kong

Hong Kong, China

Chit Ying Lai

1E office, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, 32 Ngan Shing Street, Shatin, Hong Kong

35052258

cylai@cuhk.edu.hk

Department of Obstetrics and Gynaecology, Chinese University of Hong Kong

Hong Kong, China

Effectiveness of a program of massage, controlled breathing and visualization used in Chinese primigravida during intrapartum pain relief management from 36 weeks gestation: A Randomised Control Trial

RCT on the effectiveness of childbirth massage program in Chinese primigravida during intrapartum pain relief management

初產華人婦女於妊娠36週後,使用按摩、控制性呼吸和視覺化練習在分娩疼痛管理的成效之隨機研究

NA

China

Yes

2016-07-30

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.332

pain relief management during labour

Procedure

childbirth massage

Massage techniques will be both relaxation and pain relief focused with the combination of breathing element.

Relaxation massage techniques includes arms, legs, shoulder and whole back. Pain relieving techniques will focus on the lower back.

Depends on each woman and how soon she feels sleepy and responds to the massage

at least once per week after 36 weeks gestation

women will be under standard antenatal and intrapartum care as usual

NA

NA

NA

NA

All adult Chinese low risk primiparous women who can understand and communicate with Cantonese and written Chinese, singleton with no known contraindication to vaginal delivery

single mother with no partner available to learn massage technique, mentally unfit to participate and allergic to massage oil, with multiple pregnancy, placenta praevia, preeclampsia or other serious antenatal complications

18

NA

Female

Interventional

Randomized

Blocked 2:2

Historical control

Single-blind

Investigator/research team

Parallel

Other

NA

2016-09-19

300 in each arm, total 600

Recruiting

Use of parenteral intramuscular Pethidine and other pain relief methods

choice of Pethidine injection or other pain relief methods by mother

during first stage of labour

Time of spontaneous labour onset (day onset or night onset specified)

time of spontaneous labour onset

during first stage of labour

Augmentation or induction of labour

indications of augmentation or induction of labour

during first stage of labour

Birth and neonatal outcome

Mode of delivery, Apgar score, Arterial cord blood gas, reasons to admit to Special baby care unit if any

at delivery

Pain score during labour

Visual analogue scale

after per vaginal assessment

Satisfaction to service/Satisfaction to childbirth massage

Birth experience satisfaction questionnaire/ Satisfaction questionnaire to childbirth massage

24 hours after delivery

No

2020-04-29

ChiCTR-INR-16009158

2016-09-02

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