Condition category
Pregnancy and Childbirth
Date applied
25/07/2010
Date assigned
23/09/2010
Last edited
27/09/2011
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

Prof Philip Bennett

ORCID ID

Contact details

Professor of Obstetrics and Gynaecology
Imperial College Faculty of Medicine
Institute for Reproductive and Developmental Biology
Hammersmith Hospital Campus
Du Cane Road
London
W12 0NN
United Kingdom
+44 (0)20 7594 2141
pbennett@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTA/MHRA No: 13690/0212/001-0001

Study information

Scientific title

A comparison of the effectiveness of prostaglandin gel and tablet preparations in the induction of labour at term: a randomised controlled trial

Acronym

Study hypothesis

One dinoprostone formula is associated with less induction to delivery interval than the other one.

Ethics approval

Riverside Ethics Committee approved in 2004 (ref: 04/Q0401/139)

Study design

Randomised double blinded clinical controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Induction of labour

Intervention

In patients randomised to receive dinoprostone gel, in nulliparous with an unfavourable cervix (modified bishop score less than 4), an initial dose of 2 mg was administered. In multiparaous and nulliparous women with an favourable cervix (modified bishop score 5 to 7), an initial dose of 1 mg was administered. In the patients randomised to receive dinoprostone tablets, 3 mg was administered into the posterior vaginal fornix.

The duration of dinopristone treatment is variable for each patient. It starts at patients admission to the hospital for induction of labour and can last between 1 - 4 days.

Intervention type

Drug

Phase

Not Applicable

Drug names

Prostaglandin E2

Primary outcome measures

Time interval between induction of labour to delivery in minutes, irrespective of the mode of delivery, and the rate of failed induction of labour leading to caesarean section. Assessed in every patient during the process of labour induction at gestation (greater than or equal to 36+6 to 42 weeks gestation).

Secondary outcome measures

1. Requirement for oxytocin augmentation
2. Incidence of uterine hyperstimulation, defined as uterine tachysystole (with five or more contractions in a 10 minute period for two consecutive 10 minute periods) or uterine hypertonus (a uterine contraction lasting for more than two minutes) resulting in pathological cardiotocography trace that necessitated intervention by administering of a tocolytic or delivery
3. Incidence of intrapartum foetal blood sampling
4. Epidural requirement
5. Mode of delivery
6. Blood loss at delivery
7. Incidence of maternal pyrexia
8. Perineal lacerations require suturing
9. 1 and 5-minute Apgar score
10. Need for admission to NICU

Overall trial start date

01/04/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Women undergoing induction of labour with a cephalic presentation (singleton) or first twin cephalic at term (greater than or equal to 36+6 to 42 weeks gestation)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

220

Participant exclusion criteria

1. Favourable cervix (defined as a modified Bishop score of greater than or equal to 8)
2. Any contraindication to vaginal birth
3. Previous uterine surgery (including caesarean section)
4. Unwillingness to participate in the trial

Recruitment start date

01/04/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professor of Obstetrics and Gynaecology
London
W12 0NN
United Kingdom

Sponsor information

Organisation

Queen Charlotte's and Chelsea Hospital (QCCH) (UK)

Sponsor details

DuCane Road
London
W12 0NN
United Kingdom
+44 (0)20 8383 1111
s.taher@imperial.ac.uk

Sponsor type

Hospital/treatment centre

Website

http://www.imperial.nhs.uk/qcch

Funders

Funder type

Government

Funder name

Hammersmith Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21429067

Publication citations

  1. Results

    Taher SE, Inder JW, Soltan SA, Eliahoo J, Edmonds DK, Bennett PR, Prostaglandin E2 vaginal gel or tablets for the induction of labour at term: a randomised controlled trial., BJOG, 2011, 118, 6, 719-725, doi: 10.1111/j.1471-0528.2011.02901.x.

Additional files

Editorial Notes