Immediate versus Delayed Oxytocin Following Amniotomy for labour induction

ISRCTN	ISRCTN51476259
DOI	https://doi.org/10.1186/ISRCTN51476259
Protocol serial number	733.18
Sponsor	University of Malaya (Malaysia)
Funder	University of Malaya (Malaysia)

Submission date: 13/11/2009
Registration date: 11/12/2009
Last edited: 28/01/2013

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

Contact information

Prof Peng Chiong Tan
Scientific

Dept of Obstetrics & Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Study information

Primary study design	Interventional
Study design	Double blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Immediate versus Delayed Oxytocin Following Amniotomy for labour induction in parous women with favourable cervixes: a double blind randomised controlled trial
Study acronym	IDOFA trial
Study objectives	Delayed oxytocin compared with immediate oxytocin will result less use of oxytocin but result in a proportion of vaginal deliveries achieved within 12 hours and patient satisfaction.
Ethics approval(s)	University of Malaya Medical Centre Medical Ethics Committee approved on the 31st July 2009.
Health condition(s) or problem(s) studied	Induction of labour
Intervention	After amniotomy for labour induction: 1. Immediate oxytocin (blinded) starting at 1 mU/min (3 ml/hr, doubling in rate as required every 30 minutes to achieve 3 - 4 uterine contractions every 10 minutes (or to a maximum rate of 16 mU/min (48 ml/hr) if 3 - 4 contractions per 10 minutes not achieved) in the first 4 hours 2. Saline (blinded placebo) infusion with same regime as above After 4 hours, the woman is reassessed and open label oxytocin started if clinically required and standard labour management applies.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Oxytocin
Primary outcome measure(s)	1. Vaginal delivery within 12 hours 2. Maternal satisfaction score with the birth process (10 point visual numerical rating score VNRS)
Key secondary outcome measure(s)	1. Induction to delivery interval 2. Mode of delivery/caesarean delivery 3. Use opiate/epidural analgesia in labour 4. Prenatal oxytocin use 5. Intrapartum and postpartum fever 6. Delivery blood loss 7. Maternal antibiotic use 8. Induction to hospital discharge interval 9. Apgar Score 10. Umbilical arterial blood pH 11. Neonatal jaundice requiring phototherapy or more 12. Neonatal admission
Completion date	14/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	206
Key inclusion criteria	1. Females aged over 16 years 2. Planned labour induction 3. Parous (at least 1 prior vaginal birth greater than 24 weeks) 4. Term gestation (greater than 36 weeks) 5. Bishop score on recruitment greater than or equal to 6 with cervical dilation greater than or equal to 2 cm suitable for amniotomy 6. Intact membranes 7. Singleton pregnancy 8. Cephalic presentation 9. Reassuring cardiotocograph
Key exclusion criteria	1. Previous uterine incision or injury (e.g. caesarean delivery, myomectomy, perforation) 2. Gross foetal anomaly 3. Contraindication for vaginal birth
Date of first enrolment	15/11/2009
Date of final enrolment	14/11/2010

Locations

Countries of recruitment

Malaysia

Study participating centre

Dept of Obstetrics & Gynaecology

Kuala Lumpur
50603
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes