ANZCTR - Registration

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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]

'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

Condition category

Condition code

Reproductive Health and Childbirth

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]

Prevention

Intervention code [2]

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]

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]

2 hours after the completion of the third stage of labour

Secondary outcome [1]

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]

2 hours after the completion of the third stage of labour

Secondary outcome [2]

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]

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)

Recruitment hospital [1]

King Edward Memorial Hospital - Subiaco

Recruitment postcode(s) [1]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

Kent Street, Bentley, Perth, Western Australia 6102

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Women and Newborn Ethics Committee

Ethics committee address [1]

Women and Newborn Health Service
Level 1, CCRF, Roberts Rd, SUBIACO WA 6008

Ethics committee country [1]

Date submitted for ethics approval [1]

02/10/2015

Approval date [1]

Ethics approval number [1]

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

Dr Lucy Lewis

Address

King Edward Memorial Hospital
Department of Nursing and Midwifery Education and Research
Bagot Road
Subiaco
WA, 6009

Country

Australia

Phone

61 (08) 9287-3024

Fax

Lucy.Lewis@health.wa.gov.au

Contact person for public queries

Name

Lucy Lewis

Address

King Edward Memorial Hospital
Department of Nursing and Midwifery Education and Research
Bagot Road
Subiaco
WA, 6009

Country

Australia

Phone

61 (08) 9287-3024

Fax

Lucy.Lewis@health.wa.gov.au

Contact person for scientific queries

Name

Lucy Lewis

Address

King Edward Memorial Hospital
Department of Nursing and Midwifery Education and Research
Bagot Road
Subiaco
WA, 6009

Country

Australia

Phone

61 (08) 9287-3024

Fax

Lucy.Lewis@health.wa.gov.au

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

Type	Is Peer Reviewed?	Citations or Other Details	Attachment
Basic results	No		369418-(Uploaded-25-11-2020-14-18-57)-Basic results summary.docx
Plain language summary	No	This midwifery-led project1 was performed on the L... [More Details]
Study results article	Yes	Spontaneous vaginal birth following induction with... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Spontaneous vaginal birth following induction with intravenous oxytocin: Three oxytocic regimes to minimise blood loss post birth.	2021	https://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.

Trial Review

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Documents added manually

Documents added automatically