Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000900011
Ethics application status
Approved
Date submitted
1/10/2010
Date registered
25/10/2010
Date last updated
25/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
High and low dose oxytocin for augmentation of labor
Scientific title
The effects of high versus low dose oxytocin on cesarean section rate, fetal and maternal outcomes for augmentation of labor in pregnant women gestational age > 37 weeks
Secondary ID [1] 252810 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effect of oxytocin for augmentation of labor 258314 0
Cesarean section rate 258338 0
Condition category
Condition code
Reproductive Health and Childbirth 258504 258504 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: High dose oxytocin infusion (4 mU/minute and increase the rate by 4 mU/ml every 30 minutes with maximum dose not exceed 16 mU/ml (oxytocin 10 units in isotonic solution 1,000 ml)
Arm 2: Low dose oxytocin infusion 2 mU/minute and increase the rate by 2 mU/ml every 30 minutes with maximum dose not exceed 16 mU/ml (oxytocin 10 units in isotonic solution 1,000 ml)
Intervention code [1] 257352 0
Treatment: Drugs
Comparator / control treatment
Arm 2:Low dose oxytocin infusion (2 mU/minute and increase the rate by 2 mU/ml every 30 minutes with maximum dose not exceed 16 mU/ml (oxytocin 10 units in isotonic solution 1,000 ml)
Control group
Dose comparison

Outcomes
Primary outcome [1] 259338 0
Primary outcome: Cesarean section rate, will be assessed by medical records
Timepoint [1] 259338 0
Time point: at one year after randomization
Secondary outcome [1] 265792 0
Secondary outcome: Fetal and maternal outcome, will be assessed by medical records
Timepoint [1] 265792 0
Time point: at one year after randomization

Eligibility
Key inclusion criteria
Mother criteria
1. Singleton, gestational age 37 weeks or more
2. Vertex presentation
3. Bishop score = 9 or more
4. Inadequate uterine contraction
Child criteria
1. Viable fetus
2. Singleton
3. Vertex presentation
4. well being fetus
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Contraindication for augmentation of labor e.g. malposition, placenta previa, prior uterine scar, overdistended uterus, grand multiparity
2. Cephalopelvic disproportion (CPD)
3. Dead fetus in utero (DFIU)
4. Contraindication in using oxytocin e.g. allergy to oxytocin, low blood pressure, fetal distress
5. Medical complications: hypertension, HIV infection, coagulopathy, diabetes mellitus, heart diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
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/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 2947 0
Thailand
State/province [1] 2947 0
Khon Kaen

Funding & Sponsors
Funding source category [1] 257769 0
Hospital
Name [1] 257769 0
Khon Kaen Hospital
Country [1] 257769 0
Thailand
Primary sponsor type
Individual
Name
Suppasiri Hayakungchat
Address
Khon Kaen Hospital
Srichan Road
Muang District
Khon Kaen Province
40000
Country
Thailand
Secondary sponsor category [1] 256981 0
Individual
Name [1] 256981 0
Ussanee Sangkhomkamhang Swadpanich
Address [1] 256981 0
Khon Kaen Hospital
Srichan Road
Muang District
Khon Kaen Province
40000
Country [1] 256981 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259811 0
The Ethics Committee for Research in Human Subjects, Khon Kaen Hospital
Ethics committee address [1] 259811 0
Srichan Road
Muang District
Khon Kaen Province
40000
Ethics committee country [1] 259811 0
Thailand
Date submitted for ethics approval [1] 259811 0
02/08/2010
Approval date [1] 259811 0
22/09/2010
Ethics approval number [1] 259811 0
75/01/2553

Summary
Brief summary
Dystocia is the most common cause of cesarean section in primigravida, This would be improved by adequate augmentation of labor. The augmentation methods included amniotomy, prostaglandins or oxytocin adminiatration. Intravenous oxytocin infusion was a commonly method used for augmentation of labor, but standard regimen is still inconclusive. The prior study reported that high dose oxytocin was significantly decrease cesarean section rate without serious maternal and fetal complications when compared to low dose oxytocin. However, some studies showed that high dose was not superior to low dose in augmentation of labor but only shorten delivery time. After we intensively searched and reviewed the literature, we found that no prior study has been conducted in Thailand. We therefore would like to study the effectiveness and safety of high dose oxytocin in augmentation of labor when compared to low dose oxytocin. The primary endpoint is cesarean section rate and the secondary endpoints are duration of delivery and maternal and fetal complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31730 0
Address 31730 0
Country 31730 0
Phone 31730 0
Fax 31730 0
Email 31730 0
Contact person for public queries
Name 14977 0
Suppasiri Hayakungchat
Address 14977 0
Khon Kaen Hospital
Srichan Road
Muang District
Khon Kaen Province
40000
Country 14977 0
Thailand
Phone 14977 0
+66813781283
Fax 14977 0
+6643336789 Ext.3736
Email 14977 0
[email protected]
Contact person for scientific queries
Name 5905 0
Ussanee Sangkhomkamhang Swadpanich
Address 5905 0
Khon Kaen Hospital
Srichan Road
Muang District
Khon Kaen Province
40000
Country 5905 0
Thailand
Phone 5905 0
+66812619299
Fax 5905 0
+6643336789 Ext.3736
Email 5905 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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