Condition category
Pregnancy and Childbirth
Date applied
29/10/2010
Date assigned
29/10/2010
Last edited
01/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.holds.bham.ac.uk

Contact information

Type

Scientific

Primary contact

Ms Deborah Bird

ORCID ID

Contact details

Department of Public Health and Epidemiology
Edgbaston
Birmingham
B15 2TT
United Kingdom
d.bird@bham.ac.uk

Additional identifiers

EudraCT number

2009-012752-24

ClinicalTrials.gov number

Protocol/serial number

8896

Study information

Scientific title

Acronym

HOLDS

Study hypothesis

The main hypothesis of the trial is that the use of high dose oxytocin will achieve more effective uterine contractions resulting not only in shorter labours but in a higher chance of vaginal birth in women who are diagnosed as having delay in the first stage of labour. The regimen we will evaluate has a higher starting dose, earlier attainment of conventional maximum doses (at 2 hours rather than over 4 hours) and the use of higher maximum doses of oxytocin compared to the standard regimen used at present.

Ethics approval

MREC approved on 23/06/2010 (ref: 10/H0406/30)

Study design

Multicentre randomised interventional treatment trial with an observational qualitative element

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Reproductive Health and Childb; Subtopic: Reproductive Health and Childb (all Subtopics); Disease: Reproductive Health & Childbirth

Intervention

Syntocinon, 10 IU versus 20 IU

Study entry: single randomisation only

Intervention type

Drug

Phase

Not Applicable

Drug names

Syntocinon (Oxytocin)

Primary outcome measures

Birth and early postnatal period

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2010

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consenting nulliparous women with a singleton pregnancy at term (37 - 42 weeks) gestation
2. Confirmed delay in labour as defined by NICE Intrapartum Care Guideline and with ruptured membranes
3. Labour is established when there are regular painful contractions and progressive cervical dilation from 4 cm. Delay is suspected when cervical dilatation of less than 2 cm in 4 hours occurs once labour is established. Delay is confirmed when progress of less than 1 cm in 2 hours is found on repeat vaginal examination.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned sample size: 100; UK sample size: 100

Participant exclusion criteria

1. Under 16 years old
2. Induction
3. Body mass index (BMI) greater than 40
4. Multiple pregnancy
5. Existing maternal or fetal disease or concern
6. Gestational diabetes
7. Previous uterine surgery
8. Vaginal bleeding in this pregnancy of clinical significance
9. Contra-indication to oxytocin therapy

Recruitment start date

01/11/2010

Recruitment end date

30/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Public Health and Epidemiology
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Department of Public Health and Epidemiology
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.staff.bham.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

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