Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
733.18
Study information
Scientific title
Immediate versus Delayed Oxytocin Following Amniotomy for labour induction in parous women with favourable cervixes: a double blind randomised controlled trial
Acronym
IDOFA trial
Study hypothesis
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
University of Malaya Medical Centre Medical Ethics Committee approved on the 31st July 2009.
Study design
Double blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Oxytocin
Primary outcome measure
1. Vaginal delivery within 12 hours
2. Maternal satisfaction score with the birth process (10 point visual numerical rating score VNRS)
Secondary outcome measures
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
Overall trial start date
15/11/2009
Overall trial end date
14/11/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
At least 206 women
Participant exclusion criteria
1. Previous uterine incision or injury (e.g. caesarean delivery, myomectomy, perforation)
2. Gross foetal anomaly
3. Contraindication for vaginal birth
Recruitment start date
15/11/2009
Recruitment end date
14/11/2010
Locations
Countries of recruitment
Malaysia
Trial participating centre
Dept of Obstetrics & Gynaecology
Kuala Lumpur
50603
Malaysia
Sponsor information
Organisation
University of Malaya (Malaysia)
Sponsor details
University Malaya Medical Centre
Department of Obstetrics & Gynaecology
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Malaya (Malaysia)
Alternative name(s)
University of Malaya, UM
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Malaysia
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
Basic results (scientific)
Publication list
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23344273
Publication citations
-
Results
Tan PC, Soe MZ, Sulaiman S, Omar SZ, Immediate compared with delayed oxytocin after amniotomy labor induction in parous women: a randomized controlled trial., Obstet Gynecol, 2013, 121, 2 Pt 1, 253-259, doi: http://10.1097/AOG.0b013e31827e7fd9.