Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00384

2 Trial Registration Date

2013-12-23

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.360-T

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Chor Chung Ming

ii Address

1EF, Department of Obstetrics and Gynaecology, Special Block, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, Hong Kong SAR

iii Phone

2632 3190

iv Email

cmchor@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Chor Chung Ming

ii Address

1EF, Department of Obstetrics and Gynaecology, Special Block, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, Hong Kong SAR

iii Phone

2632 3190

iv Email

cmchor@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Determination of labor progression patterns using non-invasive, ultrasound based, multiple parameters in low risk Chinese population

10 Public Title

Non-invasive ultrasound based method to determine normal curves of labor progression

i Public Title in Chinese 研究名稱

以超聲波及定位系統監察生產過程之研究

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-10-25

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Labor Progress

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Labor pro is a FDA approved system that is developed by an Israel Company, TrigMed, which use magnetic position tracker and ultarasound technology to determine the level and orientation of fetal head.[Nizard 2004]. It has been demonstrated by different studies [Haberman 2011] that it is more robust in determination of the level (station) and orientation (position) of fetal head during labour. The accuracy of vaginal examination to determine cervical dilatation was also increased using its magnetic position tracker.[Haberman 2011].

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Less than 12 hours, actual duration depends on the length of the labor progress

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Digital vaginal examination

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Nulliparous women
2. At Least 37+0 weeks
3. Spontaneous onset of labour
4. Patient with regular uterine contraction >= 2 in 10 minutes
5. Cervix >=3cm dilated

ii Exclusion Criteria

1. Risk factors of cephalopelvic disproportion
i. Gestation at 41 weeks or beyond OR
ii. Cervix dilating <= 1cm per hour in past 2 hours according to vaginal examination after entering active phase OR
iii. Baby in occipital posterior position as suggested by vaginal examination OR
iv. Most recent antenatal ultrasound scan suggestive of Big Baby (EFW >=4.0kg OR AC >=+2SD OR BPD >+2SD OR HC >+2SD). OR
v. Maternal short stature (Maternal height<150cm) OR
2. Fetal Malformation
3. Fetal Growth Restriction
i. Any USG evidence of small for gestation fetus in recent 2 weeks
4. Pelvic Surgery
5. Still Birth

iii Age Minimum

18

iv Age Maximum

50

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

Open label

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-01-01

21 Target Sample Size

200

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Station, Position

24 Secondary Outcome

Birth Weight, Mode of Delivery, Cervical dilatation

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-01-24

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-12-23