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Trial registered on ANZCTR


Registration number
ACTRN12612000117819
Ethics application status
Approved
Date submitted
22/01/2012
Date registered
24/01/2012
Date last updated
1/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of melatonin for postoperative pain relief and reduced blood loss after cesarean section
Scientific title
Evaluation of melatonin's effect on pain and blood loss after cesarean section
Secondary ID [1] 279771 0
nil
Universal Trial Number (UTN)
U1111-1127-4170
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post partum haemorrhage i n
Patients undergoing cesarean section
285643 0
post-operative pain in
Patients undergoing cesarean section
285645 0
Condition category
Condition code
Anaesthesiology 285829 285829 0 0
Anaesthetics
Reproductive Health and Childbirth 285839 285839 0 0
Fertility including in vitro fertilisation
Surgery 285850 285850 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One hundred twenty 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 40 each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated Ringer’s solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery of the neonate was infused .
Intervention code [1] 284094 0
Prevention
Intervention code [2] 284095 0
Treatment: Drugs
Comparator / control treatment
sublingual microcellulose tablet
Control group
Placebo

Outcomes
Primary outcome [1] 286339 0
Time to first requirement of analgesic supplement(analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
Timepoint [1] 286339 0
Time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution
Primary outcome [2] 286340 0
amount of blood loss after cesarean delivery
Timepoint [2] 286340 0
amount of blood loss after cesarean delivery will be assess by determination of Hemoglobin values both before surgery and 12 h following surgery
Secondary outcome [1] 295633 0
hemodynamic variables 5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 min after the injection
Timepoint [1] 295633 0
hemodynamic variables is assessed by nonivasive automatic blood pressure measurement 5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 min after the injection

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
Gender
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 the anesthesiologists during preoperative rounding.This is a double blinded clinical trial, with blinding of both the patient and the administrating practitioner to the anaesthetic type. Allocation will be managed by a Resident external to the project.Study drugs given to patients by nurse who is not involved in the study.
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4071 0
Iran, Islamic Republic Of
State/province [1] 4071 0
Qazvin

Funding & Sponsors
Funding source category [1] 284556 0
Self funded/Unfunded
Name [1] 284556 0
Marzieh Beigom Khezri
Address [1] 284556 0
Marzieh Beigom Khezri, , Department of Anesthesiology ,Qazvin University of Medical Science,boulvar bahonar,postal code:34188 99578 ,qazvin,Iran.
Country [1] 284556 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Qazvin Medical Science University
Address
Shahid bahonar,Ave3419759811 Qazvin ,Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 283477 0
Hospital
Name [1] 283477 0
Kosar Hospital
Address [1] 283477 0
Taleghani street,Qazvin,Iran
postal code:3413996134
Country [1] 283477 0
Iran, Islamic Republic Of
Other collaborator category [1] 260467 0
Individual
Name [1] 260467 0
Morteza Reihani Delkhosh
Address [1] 260467 0
Resident of Anesthesiology,Qazvin Medical Science University,shahid bahonar,Ave3419759811 Qazvin ,Iran
Country [1] 260467 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286536 0
Qazvin Medical University Science
Ethics committee address [1] 286536 0
shahid bahonar,Ave3419759811 Qazvin ,Iran
Ethics committee country [1] 286536 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 286536 0
10/06/2011
Approval date [1] 286536 0
26/12/2011
Ethics approval number [1] 286536 0
d/20/3893

Summary
Brief summary
To assess effect of melatonin on pain and amount of blood loss after cesarean delivery one hundred twenty 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 40 each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal of anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated Ringer’s solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery of the neonate was infused . Time to first requirement of analgesic supplement, Hemodynamic variables,will be recorded.Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given. For determiniation of blood loss ,change in hemoglobin levels, need for additional oxytocics and ,the volume of blood in the suction bottle was measured, blood soaked sponges. Hemoglobin values were determined both before surgery and 12 h following surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33663 0
Address 33663 0
Country 33663 0
Phone 33663 0
Fax 33663 0
Email 33663 0
Contact person for public queries
Name 16910 0
Marzieh Beigom Khezri
Address 16910 0
Marzieh Beigom Khezri, Department of Anesthesiology ,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 16910 0
Iran, Islamic Republic Of
Phone 16910 0
+98-281-2222951
Fax 16910 0
+98-281-2236378
Email 16910 0
mkhezri@qums.ac.ir
Contact person for scientific queries
Name 7838 0
Marzieh Beigom Khezri
Address 7838 0
Marzieh Beigom Khezri, Department of Anesthesiology ,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 7838 0
Iran, Islamic Republic Of
Phone 7838 0
+98-281-2222951
Fax 7838 0
+98-281-2236378
Email 7838 0
mkhezri@qums.ac.ir

No information has been provided regarding IPD availability
Summary results
No Results