Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00575

2 Trial Registration Date

2018-01-10

i Registration Status

Prospective

3 Secondary IDs

2017.522

4 Source(s) of Funding

Nil

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Not Applicable

Please specify

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

i Name

Cheung Wing Ching

ii Address

1F, EF block (special block), department of OG, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, N.T.

iii Phone

9228 5312

iv Email

cosycheung@cuhk.edu.hk

v Affiliation

Department of OG

vi Country

Hong Kong

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

i Name

Dr. CHUNG Pui Wah, Jacqueline

ii Address

1F, EF block (special block), department of OG, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, N.T.

iii Phone

35051537

iv Email

jacquelinechung@cuhk.edu.hk

v Affiliation

Department of OG

vi Country

Hong Kong

9 Official Scientific Title of the Study

Incidence of intrauterine adhesion after use of Floseal to control placental bed bleeding

10 Public Title

Incidence of intrauterine adhesion after use of Floseal to control placental bed bleeding

i Public Title in Chinese 研究名稱

使用FloSeal來停止胎盤床出血後的宮腔粘連的發生率

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?

2017-10-10

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.522

14 Medical Condition Being Studied

intrauterine adhesion

placental bed bleeding

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

All women who had Floseal applied to intrauterine cavity during Caesarean section will be invited to participate in the study by our research assistant. For those who agree to join the study, an outpatient hysteroscopy will be performed within 3-6 months from their Caesarean section by a designated team of experienced gynaecologist.

iii Dosage form of the intervention

nil

iv Dosage of the intervention

nil

v Duration of the intervention

nil

vi Frequency of the intervention

nil

16 Comparative Treatments

i Description/ name of comparative treatments

nil

ii Dosage form of the comparative treatments

nil

iii Dosage of the comparative treatments

nil

iv Duration of the comparative treatments

nil

v Frequency of the comparative treatments

nil

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

All women presenting to our unit with use of FloSeal to control postpartum haemorrhage during Caesarean Section will be invited to join the study.

ii Exclusion Criteria

Women who did not have Floseal applied in intrauterine cavity during Caesarean

iii Age Minimum

18

iv Age Maximum

60

v Gender

Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

This is not a drug trial

vi Study Objectives (Optional)

To determine the incidence of intrauterine adhesion or Asherman’s syndrome after usage of Floseal to control postpartum haemorrhage

20 Anticipated trial start date

2018-01-17

21 Target Sample Size

20

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

To determine the incidence of intrauterine adhesion or Asherman’s syndrome after usage of Floseal to control postpartum haemorrhage

ii The metric or method of measurement used

out patient hysteroscopy

iii The timepoint(s) of primary interest

3-6 months from their Caesarean section

24 Secondary Outcome

i The Name of the outcome

nil

ii The metric or method of measurement used

nil

iii The timepoint(s) of primary interest

nil

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-07-06

27 Primary Registry and Trial Identifying Number

ChiCTR1800014589

28 Date of Registration in Primary Registry

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Trial History Detail on 2020-01-21