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Trial History Detail on 2013-12-23

CUHK_CCT00384

2013-12-23

Prospective

CRE-2013.360-T

The Chinese University of Hong Kong

The Chinese University of Hong Kong

N/A

Chor Chung Ming

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

2632 3190

cmchor@cuhk.edu.hk

The Chinese University of Hong Kong

Chor Chung Ming

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

2632 3190

cmchor@cuhk.edu.hk

The Chinese University of Hong Kong

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

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

以超聲波及定位系統監察生產過程之研究

Nil

Hong Kong SAR, China

Yes

2013-10-25

Labor Progress

Device

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].

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

Digital vaginal examination

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

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

18

50

Female

Observational

Not Applicable

Not Applicable

Open label

Not Applicable

2014-01-01

200

Not Yet Recruiting

Station, Position

Birth Weight, Mode of Delivery, Cervical dilatation

No

2015-01-24


Yes

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