Condition category
Pregnancy and Childbirth
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
16/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr N Mishra

ORCID ID

Contact details

Royal Surrey County Hospital NHS Trust
Egerton Road
Guildford
GU2 7XX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0211184290

Study information

Scientific title

Acronym

Study hypothesis

We hypothesize that the slow release mechanism of vaginal insert would be effective in achieving both cervical ripening and labour onset and patient would be more satisfied remaining at home.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pregnancy and Childbirth: Labour induction

Intervention

Inpatient and outpatient groups

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Effectiveness and satisfaction:
1. Effectiveness defined in terms of proportion of women in labour or delivered within 24 hours; requirement for additional intervention e.g. epidural
2. Satisfaction defined as proportion of women with high mean ratings after 12 hours insertion/after delivery

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2006

Overall trial end date

31/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primigravida
2. Term
3. Singleton pregnancy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2006

Recruitment end date

31/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Surrey County Hospital NHS Trust
Guildford
GU2 7XX
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Royal Surrey County Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes