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Trial registered on ANZCTR


Registration number
ACTRN12612000624886
Ethics application status
Approved
Date submitted
17/04/2012
Date registered
12/06/2012
Date last updated
12/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of intravenous versus intramuscular oxytocin in the management of third stage of labor.
Scientific title
Intravenous versus intramuscular oxytocin in the management of third stage of labor for prevention of postpartum hemorrhage.
Secondary ID [1] 280350 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incidence of postpartum hemorrhage within 24 hours postpartum periods 286309 0
Hematocrit concentration , change of hematocrit at 24 hr 286312 0
Prolonged third stage of labor ( > 30 mins ) 286313 0
Oxytocin additional dose, other additional drugs 286314 0
Blood transfusion 286315 0
Condition category
Condition code
Reproductive Health and Childbirth 286554 286554 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm1: Intravenous oxytocin injection 10 units immediately after delivery of the newborn
Intervention code [1] 284715 0
Prevention
Intervention code [2] 285042 0
Treatment: Drugs
Comparator / control treatment
Arm2: Intramuscular oxytocin injection 10 units immediately after delivery of the newborn
Control group
Active

Outcomes
Primary outcome [1] 286985 0
Incidence of postpartum hemorrhage within 24 hours postpartum periods using medical records
Timepoint [1] 286985 0
at six months after randomization
Secondary outcome [1] 297143 0
Postpartum blood loss using medical records
Timepoint [1] 297143 0
at six months after randomization
Secondary outcome [2] 297144 0
Hematocrit concentration , change of hematocrit at 24 hr using medical records
Timepoint [2] 297144 0
at six months after randomization
Secondary outcome [3] 297145 0
Prolonged third stage of labor morethan 30 minutes using medical records for the time from the delivery of the infant until delivery of the maternal placenta
Timepoint [3] 297145 0
at six months after randomization
Secondary outcome [4] 297146 0
Oxytocin additional dose or other additional drugs requirement using medical records
Timepoint [4] 297146 0
at six months after randomization
Secondary outcome [5] 297147 0
Amout of blood transfusion using medical records
Timepoint [5] 297147 0
at six months after randomization
Secondary outcome [6] 297148 0
Adverse effect: hypotension during third stage of labor using medical records
Timepoint [6] 297148 0
at six months after randomization

Eligibility
Key inclusion criteria
. Singleton pregnancy with spontaneous vertex delivery
. Gestational age at least 34 weeks
. Parity < 5
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
. Cesarean section
. High risk postpartum hemorrhage ;
- Pregnancy induced hypertension (PIH) ,
- multifetal pregnancy , polyhydramnios , macrosomia ,
- Placenta previa ,Placental abruption ,Placenta accreta/increta/percreta
- hematologic problems: thrombocytopenia, coagulopathy
- Obesity ( BMI >29 ) ,Previous postpartum hemorrhage
. Previous history of curettage
. Previous manual removal of placenta
. Cardiovascular instability
. Under anesthesia
. Oxytocin hypersensitivity
. Medical problem: Diabetes mellitus (DM) , nephrotic syndrome , renal insufficiency ,sepsis

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)
The randomization assignments were placed into opaque envelopes. Based on the obtained schedule, the number of sealed envelopes, which are equal to the required blocks, will be prepared and labeled. Each envelope contains the corresponding sealed allocation cards that will allocate treatments to patients. The people, who prepare the randomized scheme, will not involve in the trial. The allocation schedule will be concealed until the end of trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After signing on the consent form, all eligible patients will be enrolled in the trial and then randomized by computer-generated randomization into two groups to receive intravenous oxytocin and intramuscular oxytocin in the management of the third stage of labor.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment outside Australia
Country [1] 4266 0
Thailand
State/province [1] 4266 0
Khon Kaen

Funding & Sponsors
Funding source category [1] 285127 0
Hospital
Name [1] 285127 0
Khon Kaen Hospital
Country [1] 285127 0
Thailand
Primary sponsor type
Hospital
Name
Khon Kaen Hospital
Address
Srichan Road
Muang
Khon Kaen
40000
Country
Thailand
Secondary sponsor category [1] 283990 0
Individual
Name [1] 283990 0
Athittaya Krungpatee
Address [1] 283990 0
Srichan Road
Muang
Khon Kaen
40000
Country [1] 283990 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287143 0
Khon Kaen Hospital Ethics committee
Ethics committee address [1] 287143 0
Khon Kaen Hospital
Srichan Road
Muang
Khin Kaen
40000
Ethics committee country [1] 287143 0
Thailand
Date submitted for ethics approval [1] 287143 0
Approval date [1] 287143 0
Ethics approval number [1] 287143 0

Summary
Brief summary
Postpartum hemorrhage (PPH) is a significant cause of maternal morbidity and mortality throughout the world especially in developing countries. Uterine atony is the most common etiology. The incidence of postpartum hemorrhage was 3.9% in women delivered vaginally. Active management in third stage of labor is accepted protocol to prevent postpartum hemorrhage. Active management in third stage of labour involves giving a prophylactic uterotonic drug, controlled cord traction to deliver the placenta and uterine massage. Routine oxytocin has been well established. Synthetic oxytocin, acts on the smooth muscle of the uterus to stimulate contractions; especially after term, when adequate oxytocin receptors. When oxytocin binds to oxytocin receptors induces increase intracellular Ca2+ releasing and the increased prostaglandin secretion all contribute to the contractile effects and inhibition of Gamma-Aminobutyric acid (GABA) receptors (this would depolarize if GABA acts as a tonic inhibitory modulator) also causes responses contractions of the uterus. Oxytocin use is advocated either intramuscularly (10 IU) or as a dilute infusion, intravenous bolus has also been used by other authors and they showed an IV bolus of oxytocin 5 to 10 IU, can be used for postpartum hemorrhage prevention after vaginal birth but is not recommended in case of elective cesarean section. At Khon Kaen Hospital guideline recommended 10 units intramuscular oxytocin for routine prophylaxis postpartum hemorrhage. The data of all deliveries in 2010 were collected .We found that postpartum hemorrhage rate 3 % follow vaginal delivery. No maternal death caused from postpartum hemorrhage . We therefore would like to conduct randomized controlled trial to compare the efficacy and safety of intravenous versus intramuscular oxytocin in the management of third stage of labor.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34082 0
Address 34082 0
Country 34082 0
Phone 34082 0
Fax 34082 0
Email 34082 0
Contact person for public queries
Name 17329 0
Athittaya Kruangpatee
Address 17329 0
Khon Kaen Hospital
Srichan Road
Muang
Khon Kaen
40000
Country 17329 0
Thailand
Phone 17329 0
+6643336789 ext 3736
Fax 17329 0
+6643336789 ext 3736
Email 17329 0
[email protected]
Contact person for scientific queries
Name 8257 0
Ussanee Sangkhomkhamhang
Address 8257 0
Khon Kaen Hospital
Srichan Road
Muang
Khon Kaen
40000
Country 8257 0
Thailand
Phone 8257 0
+6643336789 ext 3736
Fax 8257 0
+6643336789 ext 3736
Email 8257 0
[email protected]

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