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Trial History Detail on 2014-01-06

CUHK_CCT00385

2014-01-03

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

Dinoprostone vaginal extended release system (Propess) for induction of labour versus amniotomy plus syntocinon, a randomized controlled trial

Randomized controlled trial of Propess versus amniotomy and oxytocin for induction of labour

比對使用Propess (Dinoprostone 緩釋陰道藥劑)催產與人工破水及催產素催產之隨機對照研究

N/A

Hong Kong SAR, China

Yes

2013-10-25

Induction of labour

Drug

There are various preparations of vaginal prostaglandin such as gel, tablet or extended release preperation. Although trials comparing prostaglandin gel and tablets versus amniotomy and oxytocin infusion have been performed in the past, there is less data on the use of extended release prostaglandin E2 (Propess). Propess is an extended release prostaglandin E2 vaginal insert. It consists of a polymer base containing 10 mg of dinoprostone with a polyester retrieval string. It can release 0.3mg of dinoprostone per hour over 24 hours. According to the manufacturer’s instruction, it can be removed after onset of labour or after 24 hours. Since its introduction in the 90s, Propess has been demonstrated to be as safe and as effective as other forms of vaginal dinoprostone preparation [Kalkat 2008],[El Shawarby 2006],[SOGC]. However, it is not known that whether Propess can be a feasible option to imporve cost-effectiveness and enhance patient's satisfaction in induction of labour with its simple regimen in the setting of HA hospitals in Hong Kong.

This prospective randomised open-labelled study aims at comparing the cost-effectiveness and outcome of controlled release vaginal prostaglandin E2 versus amniotomy and oxytocin for induction of labour in women with favourable cervix.

Ref
Induction of labour at term. SOGC Aug 2001.
Comparison of Dinoprostone slow release pessary (Propess) with gel (Prostin) for induction oflabour at term-a randomised trial. Kalkat RK, McMillan E, Cooper H, Palmer K. J Obstet Gynaecol. 2008 Oct;28(7).
Induction of labour at term with vaginal prostaglandins preparations: a randomised controlledtrial of Prostin vs Propess. El-Shawarby SA, Connell RJ. J Obstet Gynaecol. 2006 Oct;26(7):627-30.

24 hours

Artificial Rupture of membrane plus syntocinon infusion for induction of labour.

Nulliparous pregnant women admitted to antenatal ward for induction of labour at or more than 37 weeks with favourable cervix according to modified Bishop score (>=6)

Rupture of membranes, women aleready in labour before recruitment, presence of indication for caesarean section, major fetal anomaly, women with unfavourable cervix.

18

55

Female

Interventional

Randomized

Active

Open label

Parallel

2014-02-01

376

Not Yet Recruiting

Failed induction rate

Patient satisfaction score, Total admission time ( hours)
Admssion to induction interval (hours)
Induction to delivery interval (hours)
Cost
Delivery to discharge interval (hours)

No

2015-02-04

ChiCTR-TRC-14004079


Yes

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