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Trial registered on ANZCTR


Registration number
ACTRN12612000095864
Ethics application status
Approved
Date submitted
14/01/2012
Date registered
19/01/2012
Date last updated
15/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of combined Use of Oxytocin and Misoprostol in reducing blood loss at cesarean section
Scientific title
combined Use of Oxytocin and Misoprostol versus oxytocin infusion and Misoprostol alone to
reduce blood loss at cesarean section
Secondary ID [1] 252812 0
nil
Universal Trial Number (UTN)
U1111-1117-3480
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post partum haemorrhage at cesarean section 258317 0
Condition category
Condition code
Reproductive Health and Childbirth 258506 258506 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One hundred fifty women with singleton term pregnancy
undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 50 each.,The oxytocin group(group O) received intravenous infusion of 20 units of oxytocin soon after delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved in 1liter of lactated Ringer’s solution) at the rate of 1000 ml
over a 1h period, immediately after delivery of the neonate ,The misoprostol group (groupM) received 400 microgram sublingually and infusion of lactated Ringer ( which one ampoule placebo dissolved it) and the combined misoprostol-oxytocin group(group MO) received 200 microgram and 5 iu oxytocin bolous intravenously immediately after delivery of the neonate .
Intervention code [1] 257334 0
Prevention
Intervention code [2] 284044 0
Treatment: Drugs
Comparator / control treatment
syntocinon infusion(group O)
Control group
Active

Outcomes
Primary outcome [1] 259343 0
changes in hemoglobin levels after delivery is assessed by laboratory assesment of Hb
Timepoint [1] 259343 0
Hemoglobin values will be determined both before surgery and 24 h following surgery
Primary outcome [2] 259344 0
estimated amount of blood loss at cesarean section
Timepoint [2] 259344 0
The volume of blood in the suction bottle was measured, blood soaked sponges and added to volume from suction bottle during aperative period
Primary outcome [3] 259345 0
need for additional oxytocic therapy is assesesed by surgeon request
Timepoint [3] 259345 0
during operative period
Secondary outcome [1] 265799 0
Hemodynamic variables were recorded every 5 minutes during surgery
Timepoint [1] 265799 0
Hemodynamic variables will be assessed by noninvasive electrocardiogram monitoring every 5 minutes during surgery

Eligibility
Key inclusion criteria
pregnant women at term (37—40 wks) gestation scheduled for either elective or emergency lower segment cesarean
section .
Minimum age
18 Years
Maximum age
42 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
excluding criteria:Women with any risk factor
associated with an increased risk of postpartum
hemorrhage were excluded i.e. anemia (Hb8 g%), multiple gestation, antepartum hemorrhage,poly-hydramnios, two or more previous cesarean sections and/or a history of previous rupture uterus, current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy

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)
Enrollment is decided and permission of the patient is obtained by resident ofobstetric and gynecologic during preoperative rounding. Allocation will be managed by a Resident external to the project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was based on computer-generated codes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 2928 0
Iran, Islamic Republic Of
State/province [1] 2928 0
qazvin

Funding & Sponsors
Funding source category [1] 257773 0
Self funded/Unfunded
Name [1] 257773 0
hamideh pakniat
Country [1] 257773 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Qazvin University of Medical Science
Address
Shahid bahonar,Ave3419759811 Qazvin ,Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 256984 0
Hospital
Name [1] 256984 0
kosar hospital
Address [1] 256984 0
Taleghani street,qazvin,Iran
postal code:34188 99581
Country [1] 256984 0
Iran, Islamic Republic Of
Other collaborator category [1] 251540 0
Individual
Name [1] 251540 0
Marzieh Beigom Khezri
Address [1] 251540 0
Department of Anesthesiology ,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country [1] 251540 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286494 0
Qazvin Medical University Science
Ethics committee address [1] 286494 0
shahid bahonar,Ave3419759811 Qazvin ,Iran
Ethics committee country [1] 286494 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 286494 0
08/08/2011
Approval date [1] 286494 0
07/01/2012
Ethics approval number [1] 286494 0
d/20/3892

Summary
Brief summary
To demonstrate that the combined used of low dose of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin or misoprostol alone at cesarean sectionOne hundred fifty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 50 each. The oxytocin group(group O) recieved intravenous infusion of 20 units of oxytocin soon after delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved in 1liter of lactated Ringer’s solution) at the rate of 1000 ml over a 1h period, immediately after delivery of the neonate ,The misoprostol group (groupM) received 400 µg sublingually and infusion of lactated Ringer ( which one ampoule placebo dissolved it) and the combined misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolous intravenously immediately after delivery of the neonate . The main outcome measures were blood loss at cesarean section, change in hemoglobin levels, need for additional oxytocics and drug related
side effects.The volume of blood in the suction bottle was measured, blood soaked sponges and added to volume from suction bottle. Hemoglobin values were determined both before surgery and 24 h following surgery. Hemodynamic variables were recorded every 5 minutes during surgery .The need for additional oxytocic therapy, operating time, infusion volume given intraoperatively, need for blood transfusion, side effects of study drug and any significant puerperal morbidity were also recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31672 0
Address 31672 0
Country 31672 0
Phone 31672 0
Fax 31672 0
Email 31672 0
Contact person for public queries
Name 14919 0
Marzieh Beigom Khezri
Address 14919 0
Department of Anesthesiology ,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 14919 0
Iran, Islamic Republic Of
Phone 14919 0
+98-912-3811009
Fax 14919 0
+98-281-2236378
Email 14919 0
[email protected]
Contact person for scientific queries
Name 5847 0
hamideh Pakniat
Address 5847 0
Department of Obstetrics and Gynecology,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar
postal code:34188 99581
Country 5847 0
Iran, Islamic Republic Of
Phone 5847 0
+98 912 1822448
Fax 5847 0
+98-281-2236378
Email 5847 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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