Condition category
Pregnancy and Childbirth
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
11/09/2013
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

Ms Sarah Gregson

ORCID ID

Contact details

Maternity Unit
Queen Mary's Sidcup NHS Trust
Frognal Avenue
Sidcup
Kent
DA14 6LT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0533091848

Study information

Scientific title

A single-blind randomised controlled trial comparing low dose vaginal misoprostol and dinoprostone vaginal gel for inducing labour at term

Acronym

Study hypothesis

To determine if vaginal misoprostol is a better method of inducing labour at term than dinoprostone vaginal gel.

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

Number of patients projected for 2000/2001 - 200

Condition

Pregnancy and Childbirth: Induction of labour

Intervention

1. Misoprostol
2. Dinoprostone

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Uterine tachysystole
2. Hyperstimulation
3. Presence of meconium in the amniotic fluid
4. Apgar Scores at 5 min. Umbilical arterial pH and base deficit
5. Neonatal Unit admission
6. Induction - delivery interval
7. Method of delivery
8. Bishop score at onset of labour
9. Oxytocin requirements in labour
10. Mode of delivery
11. Analgesia requirements in labour

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2000

Overall trial end date

31/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women at term (37-42 completed weeks of pregnancy)
2. Single fetus, cephalic presentation
3. Membranes may be intact or ruptured
4. Reactive fetal heart tracing

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/07/2000

Recruitment end date

31/01/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Maternity Unit
Sidcup, Kent
DA14 6LT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Queen Mary's Sidcup NHS Trust (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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15777441

Publication citations

  1. Results

    Gregson S, Waterstone M, Norman I, Murrells T, A randomised controlled trial comparing low dose vaginal misoprostol and dinoprostone vaginal gel for inducing labour at term., BJOG, 2005, 112, 4, 438-444, doi: 10.1111/j.1471-0528.2004.00496.x.

Additional files

Editorial Notes