Immediate versus Delayed Oxytocin Following Amniotomy for labour induction
| ISRCTN | ISRCTN51476259 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51476259 |
| Secondary identifying numbers | 733.18 |
- 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
Scientific
Dept of Obstetrics & Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Study information
| Study design | Double blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/11/2009 |
| Completion date | 14/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | At least 206 women |
| 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
50603
Malaysia
Sponsor information
University of Malaya (Malaysia)
University/education
University/education
University Malaya Medical Centre
Department of Obstetrics & Gynaecology
Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Website | http://www.um.edu.my/ |
|---|---|
"ROR" |
https://ror.org/00rzspn62 |
Funders
Funder type
University/education
University of Malaya (Malaysia)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
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? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2013 | Yes | No |
