Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000396325
Ethics application status
Approved
Date submitted
5/06/2008
Date registered
5/08/2008
Date last updated
5/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the efficacy of oxtyocin agonist to oxytocin in the prevention of postpartum hemorrhage (PPH) in women undergoing vaginal delivery
Scientific title
Comparison of the efficacy of oxtyocin agonist to oxytocin in the prevention of postpartum hemorrhage (PPH) in women undergoing vaginal delivery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum Hemorrhage 3232 0
vaginal delivery 3233 0
vaginal delivery and blood loss 3465 0
Condition category
Condition code
Reproductive Health and Childbirth 3399 3399 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the management of 3rd stage of labour at vaginal delivery, 100 microgram Intramuscular (IM) slow bolus injection of oxytocin agonist after infant is delivered
Intervention code [1] 2975 0
Treatment: Drugs
Comparator / control treatment
Active control: For the management of 3rd stage of labour at vaginal delivery, 10IU (International Unit) Intramuscular (IM) bolus injection of oxytocin after infant is delivered
Control group
Active

Outcomes
Primary outcome [1] 4521 0
Requirement for additional intervention (including use of additional oxytocics or uterine massage etc.). Additional intervention can be used any point of time by ongoing assessments of uterine tone, bleeding and other vital signs.dditional intervention
Timepoint [1] 4521 0
24 hours postpartum
Secondary outcome [1] 7237 0
Hemoglobin concentration at the establishment of labour and at the 1st 24hrs after vaginal delivery by blood test
Timepoint [1] 7237 0
24 hours after delivery
Secondary outcome [2] 7238 0
Measure changes in uterine tone, blood pressure or pulse before and after study drug administration
Timepoint [2] 7238 0
24 hours after vaginal delivery
Secondary outcome [3] 7239 0
Safety profiles of the study drugs by recording all side effects or adverse events should they occur. Adverse events associated with oxytocin or carbetocin may be nausea, abdominal pain, pruritis, flushing, vomiting etc, infrequent adverse events include back pain, dizziness, metallic taste, anaemia, sweating etc., any above signs of possible adverse events would be recorded in the case report form (CRF) accordingly in both delivery and recovery rooms
Timepoint [3] 7239 0
prior to discharge
Secondary outcome [4] 7653 0
Blood loss: estimated total volume of blood loss over 24h was measured by weighing all sanitary napkins and disposable bedding sheets used in delivery and then subtracting the original weight of each item
Timepoint [4] 7653 0
24 hours after delivery

Eligibility
Key inclusion criteria
Normal and healthy women who will undergo vaginal delivery, Parity I-IV, Singleton pregnancy with cephalic presentation
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Primigravida or Para V and above, History of PPH and/or uterine atony in the previous delivery, History of cardiac arrhythmia or any other clinically significant heart diseases, History of hypertension requiring treatment within the last 2 years, History of anaemia (Hb <10 g/dL), Known or suspected coagulopathy (hereditary or acquired) (eg. von Willebrand’s disease, etc), History or evidence of chronic liver, renal or endocrine disease, History of hypersensitivity to oxytocin or carbetocin, Placenta previa or abruptio placentae, Any sign of pre-existing uterine pathology or anomaly, Rupture of membrane

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)
All eligible patients after signing the informed consent form would be randomized to treatment or active control groups using an element of chance to determine the assignment in order to reduce bias. Allocation concealment was done by central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation: simple randomisation by using a randomisation table created by a comuter software using service provided by www.randomization.com online
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
13/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
720
Accrual to date
Final
Recruitment outside Australia
Country [1] 998 0
Malaysia
State/province [1] 998 0

Funding & Sponsors
Funding source category [1] 3648 0
Self funded/Unfunded
Name [1] 3648 0
Dr Farouk
Country [1] 3648 0
Malaysia
Primary sponsor type
Individual
Name
Dr Farouk
Address
Dept of Obstetrics and Gynaecology, Hospital Tengku Ampuan Rahimah, Klang
Country
Malaysia
Secondary sponsor category [1] 3127 0
Individual
Name [1] 3127 0
Dr Jegananthan
Address [1] 3127 0
Dept of Obstertics and Gynaecology, Hospital Sultanah Aminah, Johor Bahru
Country [1] 3127 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5515 0
Medical research & Ethics committee Ministry of Health Malaysia
Ethics committee address [1] 5515 0
Jalan Pahang,
50588 Kuala Lumpur
Ethics committee country [1] 5515 0
Malaysia
Date submitted for ethics approval [1] 5515 0
Approval date [1] 5515 0
10/03/2006
Ethics approval number [1] 5515 0
KKM/JEPP/02 JID.3(20)

Summary
Brief summary
This study is intended to compare the efficacy and safety of an oxytocin analogue and oxytocin in the prevention of postpartum hemorrhage (massive bleeding after birth) in women undergoing vaginal delivery. Oxytocin and its analogue are drugs used to contract the uterus to prevent postpartum hemorrhage. We would like to compare the effect of the drugs to lower the need for additional intervention (additional massage or other uterotonic needed) in the prevention of PPH postpartum hemorrhage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28648 0
Address 28648 0
Country 28648 0
Phone 28648 0
Fax 28648 0
Email 28648 0
Contact person for public queries
Name 11805 0
Dr Farouk
Address 11805 0
Dept of Obstetrics and Gynaecology, Hospital Tengku Ampuan Rahimah, Klang
Country 11805 0
Malaysia
Phone 11805 0
+603-3375 6209
Fax 11805 0
Email 11805 0
[email protected]
Contact person for scientific queries
Name 2733 0
Dr Farouk
Address 2733 0
Dept of Obstetrics and Gynaecology, Hospital Tengku Ampuan Rahimah, Klang
Country 2733 0
Malaysia
Phone 2733 0
+603-3375 6209
Fax 2733 0
Email 2733 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.