Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00507

2 Trial Registration Date

2016-04-12

i Registration Status

Prospective

3 Secondary IDs

HMRF No. 03140236

4 Source(s) of Funding

HMRF

5 Primary Sponsor

NA

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

Yvonne KY Cheng

ii Address

Department of Obstetrics and Gynaecology
1E, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

35052582

iv Email

yvonnecheng@cuhk.edu.hk

v Affiliation

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Yvonne KY Cheng

ii Address

Department of Obstetrics and Gynaecology
1E, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

35052582

iv Email

yvonnecheng@cuhk.edu.hk

v Affiliation

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Perioperative prophylactic internal iliac artery balloon occlusion in the prevention of postpartum haemorrhage in placenta praevia: a randomized controlled trial

10 Public Title

Perioperative prophylactic internal iliac artery balloon occlusion in the prevention of postpartum haemorrhage in placenta praevia: a randomized controlled trial

i Public Title in Chinese 研究名稱

圍手術期預防性髂內動脈球囊閉塞術對預防前置胎盤產後出血的隨機對照研究

11 Short Title (Optional)

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?

2015-12-28

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.260-T

14 Medical Condition Being Studied

Placenta praevia

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Internal iliac artery balloon occlusion

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

Before caesarean section

vi Frequency of the intervention

Before caesarean section

16 Comparative Treatments

i Description/ name of comparative treatments

No intervention

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

Pregnant women with placenta praevia undergoing caesarean section

ii Exclusion Criteria

Age <18 years, mentally handicapped or severely ill

Fetus diagnosed with in-utero death

Contraindicated for internal iliac artery balloon occlusion

Unstable clinical condition in which patients could not be sent to interventional radiology suite for pre-operative internal iliac artery catheter placement

unable to understand English or Chinese

iii Age Minimum

18

iv Age Maximum

NA

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomized controlled trial

ii Nature of control

Placebo

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

Not yet started recruitment

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-05-03

21 Target Sample Size

44

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Reduction in postpartum haemorrhage

ii The metric or method of measurement used

Blood loss

iii The timepoint(s) of primary interest

At the time of delivery

24 Secondary Outcome

i The Name of the outcome

Haemglobin level

ii The metric or method of measurement used

Haemoglobin level

iii The timepoint(s) of primary interest

Peripartum

Secondary Outcome

i The Name of the outcome

Blood product transfusion

ii The metric or method of measurement used

Amount of blood product transfusion

iii The timepoint(s) of primary interest

Peripartum

Secondary Outcome

i The Name of the outcome

Incidence of hysterectomy

ii The metric or method of measurement used

Incidence of hysterectomy

iii The timepoint(s) of primary interest

Peripartum

Secondary Outcome

i The Name of the outcome

Maternal complications

ii The metric or method of measurement used

Maternal complications

iii The timepoint(s) of primary interest

Peripartum

Secondary Outcome

i The Name of the outcome

Days of hospital stay

ii The metric or method of measurement used

Days of hospital stay

iii The timepoint(s) of primary interest

Peripartum

Secondary Outcome

i The Name of the outcome

Admission to ICU

ii The metric or method of measurement used

Admission to ICU

iii The timepoint(s) of primary interest

Peripartum

Secondary Outcome

i The Name of the outcome

Maternal death

ii The metric or method of measurement used

Maternal death

iii The timepoint(s) of primary interest

Peripartum

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-09-16

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-16008281

28 Date of Registration in Primary Registry

2016-04-12

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Trial History Detail on 2018-09-10