High or Low Dose Syntocinon (Oxytocin) for delay in labour

ISRCTN	ISRCTN23847193
DOI	https://doi.org/10.1186/ISRCTN23847193
EudraCT/CTIS number	2009-012752-24
Secondary identifying numbers	8896

Submission date: 29/10/2010
Registration date: 29/10/2010
Last edited: 28/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Ms Deborah Bird
Scientific

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

Phone	+44 121 414 6754
Email	d.bird@bham.ac.uk

Study information

Study design	Multicentre randomised interventional treatment trial with an observational qualitative element
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	High or Low Dose Syntocinon (Oxytocin) for delay in labour
Study acronym	HOLDS
Study objectives	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(s)	23/06/2010 (ref: 10/H0406/30)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Syntocinon (Oxytocin)
Primary outcome measure	Birth and early postnatal period
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/11/2010
Completion date	30/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned sample size: 100; UK sample size: 100
Total final enrolment	94
Key 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.
Key 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
Date of first enrolment	01/11/2010
Date of final enrolment	30/09/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Public Health and Epidemiology

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

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

Website	http://www.staff.bham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results			28/05/2020	No	No
HRA research summary			28/06/2023	No	No

Editorial Notes

28/05/2020: The following changes were made to the trial record:
1.Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
11/05/2017: No publications found in PubMed, verifying study status with principal investigator