Condition category
Pregnancy and Childbirth
Date applied
13/11/2009
Date assigned
11/12/2009
Last edited
28/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peng Chiong Tan

ORCID ID

Contact details

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

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 measures

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

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

http://www.um.edu.my/

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

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23344273

Publication citations

  1. 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.

Additional files

Editorial Notes