Plain English Summary
Not provided at time of registration
Trial website
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
+44 121 414 6754
d.bird@bham.ac.uk
Additional identifiers
EudraCT number
2009-012752-24
ClinicalTrials.gov number
Protocol/serial number
8896
Study information
Scientific title
High or Low Dose Syntocinon (Oxytocin) for delay in labour
Acronym
HOLDS
Study hypothesis
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.
Ethics approval
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
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