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Trial registered on ANZCTR


Registration number
ACTRN12623000238673
Ethics application status
Approved
Date submitted
20/02/2023
Date registered
6/03/2023
Date last updated
6/03/2023
Date data sharing statement initially provided
6/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a combination of fluid restriction and the use of oxytocin in a pulsatile fashion (intermittent boluses) for women requiring an induction, result in a reduction in the duration of labour, defined by the commencement of oxytocin until the birth of the neonate, when compared to a regime of fluid restriction with continuous oxytocin?
Scientific title
Combined pulsatile oxytocin and fluid restriction study: A randomised controlled trial of women requiring an induction of labour, comparing pulsatile oxytocin to continuous oxytocin and the effect that this has on the duration of labour, as defined by the commencement of oxytocin until the birth of the neonate.
Secondary ID [1] 308535 0
Nil
Universal Trial Number (UTN)
U1111-1285-6461
Trial acronym
The COMPLETE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Labour (induction of) 328368 0
Childbirth 329151 0
Condition category
Condition code
Reproductive Health and Childbirth 325406 325406 0 0
Antenatal care
Reproductive Health and Childbirth 325407 325407 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 325408 325408 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pregnant females who require an induction and/or augmentation of their labour, will be randomised to either an intravenous continuous oxytocin infusion (which is commenced at 2 mls/hour from a stock solution of 500 mls of Hartmann's solution containing 30 IU of oxytocin), with the rate increased every 30 minutes until there are 4 uterine contractions within 10 minutes, as per Safer Care Victoria's maternity e-handbook, as opposed to the same concentration of oxytocin, but given in a pulsatile fashion.

As per Institutional policy and as per Safer Care Victoria's maternity e-handbook, using a stock solution of 10 IU oxytocin in 1000 ml crystalloid, oxytocin is commenced at an initial infusion rate of 12 ml/hr, which is then increased in a stepwise fashion, every 30 minutes, until 4 uterine contractions occur within 10 minutes. The maximum allowable rate of infusion to allow the uterus to contract 4 times within 10 minutes is 192 ml/hr. For this study, the stock solution of oxytocin to be used is the Queensland concentration of 30 IU oxytocin in 500 ml crystalloid, which is 6x greater the concentration of the Victorian stock solution. Therefore, for the continuous arm of the study, rather than initially commencing at 12 ml/hr, the equivalent volume would be 2 ml/hr and the maximum allowable rate of infusion would be 32 ml/hr. For the pulsatile arm of the study, rather than a continuous infusion of 12 ml/hr the equivalent 'pulse' is 0.1 ml every 3 minutes. For the maximum allowable rate of 32 ml/hr, this equates to a 'pulse' of 1.6 ml every 3 minutes.

A table showing the rates of infusion for both the continuous and pulsatile arms of the study will be provided to the midwife caring for the woman having an induction of labour and the table will also be attached to the pump used to deliver the oxytocin in either a continuous or pulsatile fashion. The initial programming of the pumps and education of the midwife caring for the woman having an induction of labour, will be provided by Darren Lowen, after the participant has been consented to the study. This will ensure that the intervention protocol is adopted and all participant's medical records will be audited to confirm that this is the case.
Intervention code [1] 324977 0
Prevention
Intervention code [2] 324978 0
Treatment: Drugs
Comparator / control treatment
For pulsatile oxytocin, the same stock solution of oxytocin is used (30 IU in 500 mls Hartmann's). As per continuous oxytocin, the starting rate for the pulsatile oxytocin is 2 ml/hr with a 'pulse' given every 3 minutes, which equates to 0.1 ml boluses (20 'pulses' of o.1 ml given per hour). As per continuous oxytocin, the rate is increased in a stepwise fashion until labour is established with 4 uterine contractions within 10 minutes. As per institutional policy, the maximum rate for continuous oxytocin is 32 ml/hr, which equates to 1.6 ml bolues every 3 minutes for the pulsatile arm of the study.
Control group
Active

Outcomes
Primary outcome [1] 333264 0
The primary outcome is the duration of labour as defined by the commencement of oxytocin, until the birth of the neonate. The time of commencement of oxytocin is documented in the participant's medical record, as is the time of birth of the neonate. The elapsed time between these two time points will be calculated in minutes, thus providing the duration of labour, in minutes.
Timepoint [1] 333264 0
The primary timepoint is the birth of the neonate.
Secondary outcome [1] 416399 0
The incidence of unplanned caesarean sections is a secondary outcome. We will determine if this outcome has occurred by quering the patient's medical record.
Timepoint [1] 416399 0
The secondary timepoint is when birth has occurred.
Secondary outcome [2] 416400 0
The incidence of instrumental deliveries (foreceps/ventouse) is a secondary outcome. We will determine if this outcome has occurred by quering the patient's medical record.
Timepoint [2] 416400 0
The secondary timepoint is when birth has occurred.
Secondary outcome [3] 416401 0
The incidence of operative delivery (instrumental and emergency caesarean section) is a secondary outcome. We will determine if this outcome has occurred by quering the patient's medical record.
Timepoint [3] 416401 0
The secondary timepoint is when birth has occurred.
Secondary outcome [4] 416402 0
The incidence of epidural analgesia required is a secondary outcome.. We will determine if this outcome has occurred by quering the patient's medical record.
Timepoint [4] 416402 0
This outcome will be queried after birth of the neonate has occurred, by a retrospective analysis of the patient's medical record.
Secondary outcome [5] 416403 0
The incidence of all cause neonatal admission to the special care nursery is a secondary outcome.. A medical record number (MRN) for the neonate is listed on the birth summary of the mother. We will use the MRN to determine if the neonate was admitted to the special care nursey. All admissions of neonates to the special care nursery are documented in the neonate's medical record. Additionally, the reason for admission and discharge summary from the special care nursery for the neonate is documented as part of the medical record. Therefore, this outcome will be determined by the retrospective analyis of the neonate's medical record.
Timepoint [5] 416403 0
Two weeks post birth of the neonate, we will determine if the neonate had been admitted to the special care nursery, within the previous two week period.
Secondary outcome [6] 416404 0
The incidence of uterine tachysystole is a secondary outcome. Any cardiotocograph abnormalities, including uterine tachysystole, are documented in the participant's medical record. Therefore, this outcome will be determined by the retrospective analyis of the pariticipant's medical record.
Timepoint [6] 416404 0
The presence of uterine tachysystole is documented in the participant's medical record during the time of commencement of induction of labour until the birth of the neonate.
Secondary outcome [7] 416405 0
The incidence of uterine hypertonus is a secondary outcome. Any cardiotocograph abnormalities, including uterine hypertonus, are documented in the participant's medical record. Therefore, this outcome will be determined by the retrospective analyis of the pariticipant's medical record.
Timepoint [7] 416405 0
The presence of uterine hypertonus is documented in the participant's medical record during the time of commencement of induction of labour until the birth of the neonate.
Secondary outcome [8] 416406 0
The incidence of uterine hyperstimulation. Any cardiotocograph abnormalities, including uterine hyperstimulation, are documented in the participant's medical record. Therefore, this outcome will be determined by the retrospective analyis of the pariticipant's medical record.
Timepoint [8] 416406 0
The presence of uterine hyperstimulation is documented in the participant's medical record during the time of commencement of induction of labour until the birth of the neonate.
Secondary outcome [9] 416407 0
The total dose of oxytocin received is a secondary outcome. The rate of oxytocin infusion is charted every 30 mins on the participant's partogram, which is part of the participant's medical record. Therefore, this outcome will be determined by the retrospective analyis of the pariticipant's medical record.
Timepoint [9] 416407 0
Birth of the neonate is the timepoint at which retrospective analysis of the total dose of oxytocin required will be calculated.
Secondary outcome [10] 416408 0
Incidence of postpartum haemorrhage (defined as estimated blood loss >= 500 ml) post delivery. The incidence and amount of postpartum haemorrhage is documented within the participant's medical record. Therefore, this outcome will be determined by the retrospective analyis of the pariticipant's medical record.
Timepoint [10] 416408 0
Post partum haemorrhage occurs from the time of birth until the first 24 hours post birth of the neonate. Therefore at 24 hours post neonatal birth, we will determine the incidence of post partum haemorrhage.
Secondary outcome [11] 416409 0
Incidence of severe postpartum haemorrhage (defined as an estimated blood loss >= 1500 ml) post delivery. The incidence and amount of postpartum haemorrhage is documented within the participant's medical record. Therefore, this outcome will be determined by the retrospective analyis of the pariticipant's medical record.
Timepoint [11] 416409 0
Severe post partum haemorrhage occurs from the time of birth until the first 24 hours post birth of the neonate. Therefore at 24 hours post neonatal birth, we will determine the incidence of severe post partum haemorrhage.
Secondary outcome [12] 416410 0
Umbilical cord arterial pH <= 7.00. For this study, umbilical cord blood gas analysis will be performed for every birth, the data of which, is recorded in the neonate's medical record. Therefore, this outcome will be determined by the retrospective analyis of the neonatal medical record.
Timepoint [12] 416410 0
The umbilical cord is sampled after the birth of the neonate.
Secondary outcome [13] 416411 0
Umbilical cord lactate >= 6.1. For this study, umbilical cord blood gas analysis, which includes lactate values, will be performed for every birth, the data of which is recorded in the neonate's medical record. Therefore, this outcome will be determined by the retrospective analyis of the neonatal medical record.
Timepoint [13] 416411 0
The umbilical cord is sampled after the birth of the neonate.
Secondary outcome [14] 416412 0
Apgar score <= 7 at 5 minutes. The apgar score is calculated by the midwife, during the first 5 minutes post birth of the neonate, which is recorded in the participant's medical record, as part of the birth discharge summary. Therefore, this outcome will be determined by the retrospective analyis of the pariticipant's medical record.
Timepoint [14] 416412 0
The Apgar score is recorded 5 minutes post birth of the neonate.
Secondary outcome [15] 416413 0
Incidence of neonatal hyperbilirubinaemia, either necessitating the use of phototherapy, or documented on the discharge summary from the special care unit. If a neonate is admitted to the special care nursery an admission and discharge summary is created, the results of which are recorded in the neonate's medical record. Therefore, this outcome will be determined by the retrospective analyis of the neonatal medical record.
Timepoint [15] 416413 0
We will determine if the neonate has been admitted to the special care nursery by retrospective analysis of the neonate's medical record, after two weeks has elapsed since the birth of the neonate.
Secondary outcome [16] 416414 0
Incidence of sustained exclusive breastfeeding. For those women who plan to breastfeed, permission will be obtained to enquire about breast feeding status via telephone at 1 month and 3 months post birth of the neonate. This outcome will be assessed, as reported by the mother at these two time periods. If the mother is not breastfeeding exclusively at 1 month, a further telephone call at 3 months is no longer necessary.
Timepoint [16] 416414 0
1 month post birth of the neonate
Secondary outcome [17] 416415 0
Incidence of sustained exclusive breastfeeding. For those women who plan to breastfeed, permission will be obtained to enquire about breast feeding status via telephone at 1 month and 3 months post birth of the neonate. This outcome will be assessed, as reported by the mother at these two time periods. If the mother is not breastfeeding exclusively at 1 month, a further telephone call at 3 months is no longer necessary.
Timepoint [17] 416415 0
3 months post birth of the neonate

Eligibility
Key inclusion criteria
Any of the indications for induction of labour as per institutional policy including the following:
Diabetes (Type I, Type II, gestational diabetes, which is poorly controlled)
Hypertension
Pre-eclampsia
Prolonged pregnancy defined as being greater than 41 weeks and 3 days
Term prolonged rupture of membranes
Reduced fetal movements +/- non-reassuring CTG
Past history of fetal death in utero
Chorioamnionitis
Low PAPP-A
Advanced maternal age (defined as greater than or equal to 40 years of age)
Blood group isoimmunisation
Suspected intrauterine growth restriction
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 18 years
Women who do not have the mental and/or legal capacity to consent
Fetal presentation other than cephalic
Gestational age < 37 weeks
Multiple pregnancy
Augmentation of labour

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)
Sealed, sequentially numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based upon an analysis of all of the birthing outcomes for 2017 at The Northern Hospital and a clinically significant differernce in emergency (unplanned) caesarean section rates of 50%, with an alpha of 0.05 and a power of 80%, we calculate that we will need 412 participants. Although this is a secondary outcome, we cannot calculate a power analysis for the primary outcome, as the data for duration of labour, defined as commencement of oxytocin until the birth of the neonate, has not been captured previously.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/03/2023
Actual
Date of last participant enrolment
Anticipated
29/02/2024
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
412
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23660 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 39083 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 312782 0
Self funded/Unfunded
Name [1] 312782 0
Country [1] 312782 0
Primary sponsor type
Hospital
Name
Northern Health
Address
185 Cooper Street
Epping VIC 3076
Country
Australia
Secondary sponsor category [1] 314418 0
None
Name [1] 314418 0
Address [1] 314418 0
Country [1] 314418 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312073 0
Austin Human Research Ethics Committee
Ethics committee address [1] 312073 0
Ethics committee country [1] 312073 0
Australia
Date submitted for ethics approval [1] 312073 0
13/11/2022
Approval date [1] 312073 0
16/02/2023
Ethics approval number [1] 312073 0
HREC/90672/Austin/2022

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123370 0
Dr Darren Lowen
Address 123370 0
Department of Anaesthesia & Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 123370 0
Australia
Phone 123370 0
+61 402 832 336
Fax 123370 0
Email 123370 0
dlowen@gmp.usyd.edu.au
Contact person for public queries
Name 123371 0
Darren Lowen
Address 123371 0
Department of Anaesthesia & Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 123371 0
Australia
Phone 123371 0
+61 402 832 336
Fax 123371 0
Email 123371 0
dlowen@gmp.usyd.edu.au
Contact person for scientific queries
Name 123372 0
Darren Lowen
Address 123372 0
Department of Anaesthesia & Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 123372 0
Australia
Phone 123372 0
+61 402 832 336
Fax 123372 0
Email 123372 0
dlowen@gmp.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after it has been de-identified
When will data be available (start and end dates)?
Data will be made available immediately following publication, with no end date
Available to whom?
Only to researchers who provide a methodologically sound proposal and at the discretion of the primary sponsor
Available for what types of analyses?
Data will be available for any purpose, provided that the data achieves the amis in the approved proposal, at the discretion of the primary sponsor. Data will be made available for meta-analyses
How or where can data be obtained?
In additiona to Institutional policy with regards to release of data, data will be made available subject to approval by the principal investigator, via e-mail address dlowen@gmp.usyd.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.