Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00525

2 Trial Registration Date

2016-09-02

i Registration Status

Prospective

3 Secondary IDs

2016.332

4 Source(s) of Funding

No

5 Primary Sponsor

No

6 Secondary Sponsor

No

Function

Not Applicable

Please specify

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

i Name

Lai Chit Ying

ii Address

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

iii Phone

+852 35052258

iv Email

cylai@cuhk.edu.hk

v Affiliation

Department of Obstetrics and Gynaecology, Chinese University of Hong Kong

vi Country

Hong Kong, China

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

i Name

Chit Ying Lai

ii Address

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

iii Phone

35052258

iv Email

cylai@cuhk.edu.hk

v Affiliation

Department of Obstetrics and Gynaecology, Chinese University of Hong Kong

vi Country

Hong Kong, China

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

NA

12 Countries of Recruitment

China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-07-30

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.332

14 Medical Condition Being Studied

pain relief management during labour

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

childbirth massage

iii Dosage form of the intervention

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

iv Dosage of the intervention

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

v Duration of the intervention

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

vi Frequency of the intervention

at least once per week after 36 weeks gestation

16 Comparative Treatments

i Description/ name of comparative treatments

women will be under standard antenatal and intrapartum care as usual

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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

ii Exclusion Criteria

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

iii Age Minimum

18

iv Age Maximum

NA

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Blocked 2:2

ii Nature of control

Historical control

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-09-19

21 Target Sample Size

300 in each arm, total 600

22 Recruitment Status

Complete

23 Primary Outcome

i The Name of the outcome

Use of parenteral intramuscular Pethidine and other pain relief methods

ii The metric or method of measurement used

choice of Pethidine injection or other pain relief methods by mother

iii The timepoint(s) of primary interest

during first stage of labour

Primary Outcome

i The Name of the outcome

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

ii The metric or method of measurement used

time of spontaneous labour onset

iii The timepoint(s) of primary interest

during first stage of labour

Primary Outcome

i The Name of the outcome

Augmentation or induction of labour

ii The metric or method of measurement used

indications of augmentation or induction of labour

iii The timepoint(s) of primary interest

during first stage of labour

Primary Outcome

i The Name of the outcome

Birth and neonatal outcome

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

at delivery

24 Secondary Outcome

i The Name of the outcome

Pain score during labour

ii The metric or method of measurement used

Visual analogue scale

iii The timepoint(s) of primary interest

after per vaginal assessment

Secondary Outcome

i The Name of the outcome

Satisfaction to service/Satisfaction to childbirth massage

ii The metric or method of measurement used

Birth experience satisfaction questionnaire/ Satisfaction questionnaire to childbirth massage

iii The timepoint(s) of primary interest

24 hours after delivery

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-04-29

27 Primary Registry and Trial Identifying Number

ChiCTR-INR-16009158

28 Date of Registration in Primary Registry

2016-09-02

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Trial History Detail on 2018-03-15