Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00385

2 Trial Registration Date

2014-01-03

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

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

10 Public Title

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

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

N/A

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

Induction of labour

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

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.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

24 hours

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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

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

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)

ii Exclusion Criteria

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

iii Age Minimum

18

iv Age Maximum

55

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-02-01

21 Target Sample Size

376

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Failed induction rate

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-02-04

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004079

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 2014-01-06