Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001173583p
Ethics application status
Submitted, not yet approved
Date submitted
9/10/2015
Date registered
2/11/2015
Date last updated
2/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of immediate cessation of intravenous oxytocin post birth on postpartum haemorrhage in spontaneous vaginal delivery following induction of labour with oxytocin: a comparison of three regimes.
Scientific title
The effect of cessation of intravenous oxytocin in women who have had an induction of labour with intravenous oxytocin and a spontaneous vaginal delivery, on postpartum measured blood loss: a three armed randomised controlled trial
Secondary ID [1] 287581 0
'Nil'
Universal Trial Number (UTN)
U1111-1175-0432
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum blood loss 296366 0
Condition category
Condition code
Reproductive Health and Childbirth 296639 296639 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1, Intravenous oxytocin ceased within 15 minutes of completion of the third stage of labour.
Arm2,Intravenous oxytocin ceased 30 minutes after completion of the third stage of labour.
Arm 3, Intravenous oxytocin ceased 60 minutes after completion of the third stage of labour.


Oxytocin is titrated up from 12 to 108 mls per hour until contractions are established therefore some women will need 60 mls to get into established labour and some women will need 108mls. For analysis women will be grouped into low medium and high groups for the maximum amount of oxytocin reached.
Intervention code [1] 292977 0
Prevention
Intervention code [2] 293067 0
Treatment: Drugs
Comparator / control treatment
The control arm is arm 1,where intravenous oxytocin ceased within 15 minutes of completion of the third stage of labour.
Control group
Active

Outcomes
Primary outcome [1] 296330 0
Total measured blood loss (all bedding etc weighed in conjunction with actual blood loss) in women who have intravenous oxytocin ceased after completion of the third stage of labour.

Please note that intravenous oxytocin is generally titrated up in labour from 12 to 108 mls per hour depending on the strength and length of contractions. For analysis women will be grouped into a low medium and high group according to the maximum amount of oxytocin reached
Timepoint [1] 296330 0
2 hours after the completion of the third stage of labour
Secondary outcome [1] 318186 0
The proportion of women who have a postpartum haemorrhage (blood loss greater than or equal to 500mls), when intravenous oxytocin is ceased at 15, 30 or 60 minutes following completion of the third stage of labour, for women who receive syntometrine management of the third stage of labour. Syntometrine is not given to women who
have high bood pressure-67% in our hospital recieves Syntometrine. It is the prefered drug for third stage of labour
Timepoint [1] 318186 0
2 hours after the completion of the third stage of labour
Secondary outcome [2] 318187 0
The proportion of women who have a postpartum haemorrhage (blood loss greater than or equal to 500mls), when intravenous oxytocin is ceased at 15, 30 or 60 minutes following completion of the third stage of labour, for women who receive syntocinon management of the third stage of labour
Syntocinon is given in 33% of women in our hospital for third stage labour. Generally this is given to women who have raised blood pressure/cardiac abnormalities.
Timepoint [2] 318187 0
2 hours after the completion of the third stage of labour

Eligibility
Key inclusion criteria
Women would be included in the study if they:
Are more than or equal to 16 years old.
Receive intrapartum oxytocin for induction of labour.
Have a singleton pregnancy.
Are more than or equal to 37 weeks gestation.
Have a spontaneous vaginal delivery.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women would be excluded from the study if they:
Are <16 years old.
Have a multiple pregnancy.
Are <37 weeks gestation.
Commence intravenous oxytocin as part of the postpartum haemorrhage regime.
Have an assisted vaginal delivery.
Have a caesarean section.
Have their intravenous oxytocin ceased before delivery.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To ensure complete allocation concealment an individual not associated with the study will place the computer generated randomised groups (1, 2 and 3) into the opaque numbered envelopes for allocation (in sequence with the number of women recruited)..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Third party, distant, internet –randomisation will be utilised to guarantee randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis
To check that randomisation has been effective the baseline differences between groups (e.g. age, gestation, maximum millilitres of oxytocin infused per hour) will be investigated using t- tests. Categorical data (such as the type of oxytocic administered for third stage) will be assessed using Chi–square or Fisher exact test. Univariate logistic regression analysis will be used to identify the significant candidate predictors for their associations with measured blood loss. Multivariable logistic regression will be used to identify simultaneous factors associated with measured blood loss, with the covariate effects summarised using odds ratios and 95% confidence intervals.
We estimate that a total of 312 participants will need to be recruited to adequately power this study. We are planning a study of independent cases and controls with one control per two cases. The failure rate among controls (postpartum haemorrhage) is 0.39 in our study centre. If the true failure rate for the experimental subjects is 0.19, we will need to study 80 control subjects and 80 experimental subjects to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal with 80% power in a two armed trial. As this is a three armed randomised controlled trial we need to multiply n=80 by 1.3 to maintain power. Therefore, we need 104 in each group (a total of n=312) to detect a 20% change in proportions. The type one error probability is 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/01/2016
Actual
Date of last participant enrolment
Anticipated
19/01/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
312
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4442 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 10649 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 292198 0
University
Name [1] 292198 0
Curtin University
Country [1] 292198 0
Australia
Primary sponsor type
University
Name
Curtin University School of Nursing Midwifery and Paramedicine
Address
Kent Street, Bentley, Perth, Western Australia 6102
Country
Australia
Secondary sponsor category [1] 290875 0
None
Name [1] 290875 0
Address [1] 290875 0
Country [1] 290875 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293668 0
Women and Newborn Ethics Committee
Ethics committee address [1] 293668 0
Women and Newborn Health Service
Level 1, CCRF, Roberts Rd, SUBIACO WA 6008
Ethics committee country [1] 293668 0
Date submitted for ethics approval [1] 293668 0
02/10/2015
Approval date [1] 293668 0
Ethics approval number [1] 293668 0

Summary
Brief summary
Oxytocin is a hormone which stimulates the smooth muscle of the uterus, producing rhythmic contractions, towards the end of pregnancy, during labour and after delivery. Synthetic oxytocin is a drug which is given to women in a drip (intravenous infusion) to help start (induce) and continue labour. Synthetic oxytocin is used because it helps establish contractions in a pattern similar to that of normal labour.
If a woman has a spontaneous vaginal birth, it is generally the midwife who decides when to stop the synthetic oxytocin infusion after the birth of the baby. However, if she has an assisted vaginal birth (such as a vacuum or forceps birth) or caesarean birth, it may be the obstetrician who decides when to stop the synthetic oxytocin infusion after the birth of the baby.
We are investigating the best time for the midwife to stop the synthetic oxytocin infusion after a spontaneous vaginal birth. We want to investigate this topic as there is no current evidence to guide this clinical practice.
The primary aim of this study is to determine the proportion of women who have a postpartum haemorrhage, when intravenous oxytocin is ceased at 15, 30 or 60 minutes following completion of the third stage of labour.
We hypothesise women who have intrapartum, intravenous oxytocin ceased at 15, 30 or 60 minutes following completion of the third stage of labour will experience the same rates of postpartum haemorrhage.
We estimate that a total of 312 participants will need to be recruited to adequately power this study
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60730 0
Dr Lucy Lewis
Address 60730 0
King Edward Memorial Hospital
Department of Nursing and Midwifery Education and Research
Bagot Road
Subiaco
WA, 6009
Country 60730 0
Australia
Phone 60730 0
61 (08) 9287-3024
Fax 60730 0
Email 60730 0
[email protected]
Contact person for public queries
Name 60731 0
Dr Lucy Lewis
Address 60731 0
King Edward Memorial Hospital
Department of Nursing and Midwifery Education and Research
Bagot Road
Subiaco
WA, 6009
Country 60731 0
Australia
Phone 60731 0
61 (08) 9287-3024
Fax 60731 0
Email 60731 0
[email protected]
Contact person for scientific queries
Name 60732 0
Dr Lucy Lewis
Address 60732 0
King Edward Memorial Hospital
Department of Nursing and Midwifery Education and Research
Bagot Road
Subiaco
WA, 6009
Country 60732 0
Australia
Phone 60732 0
61 (08) 9287-3024
Fax 60732 0
Email 60732 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3813Basic resultsNo 369418-(Uploaded-25-11-2020-14-18-57)-Basic results summary.docx
4008Plain language summaryNo This midwifery-led project1 was performed on the L... [More Details]
4574Study results articleYes Spontaneous vaginal birth following induction with... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSpontaneous vaginal birth following induction with intravenous oxytocin: Three oxytocic regimes to minimise blood loss post birth.2021https://dx.doi.org/10.1016/j.wombi.2020.05.006
N.B. These documents automatically identified may not have been verified by the study sponsor.