Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section
Primary Purpose
Post Partum Haemorrhage in Patients Undergoing Cesarean Section
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
melatonin 3mg
melatonin 6mg
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Post Partum Haemorrhage in Patients Undergoing Cesarean Section focused on measuring Post partum haemorrhage, Cesarean, Pain
Eligibility Criteria
Inclusion Criteria:
- pregnant women at term (37-40 wks) gestation scheduled for either elective or emergency lower segment cesarean section
Exclusion Criteria:
- women with any risk factor associated with an increased risk of postpartum hemorrhage were excluded i.e. 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 ,anemia (Hb8 g%)or known coagulopathy
Sites / Locations
- Qazvin Medical Science University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
melatonin 3mg
melatonin 6mg
placebo
Arm Description
Outcomes
Primary Outcome Measures
Time to first requirement of analgesic supplement
amount of blood loss after cesarean delivery
Secondary Outcome Measures
hemodynamic variables
Full Information
NCT ID
NCT01572805
First Posted
April 3, 2012
Last Updated
October 10, 2012
Sponsor
Qazvin University Of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01572805
Brief Title
Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the 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 determination 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Haemorrhage in Patients Undergoing Cesarean Section
Keywords
Post partum haemorrhage, Cesarean, Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
melatonin 3mg
Arm Type
Active Comparator
Arm Title
melatonin 6mg
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
melatonin 3mg
Intervention Description
To receive sublingual 3 mg melatonin before spinal of anesthesia .
Intervention Type
Drug
Intervention Name(s)
melatonin 6mg
Intervention Description
To receive sublingual 6 mg melatonin before spinal of anesthesia .
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
To receive sublingual placebo tablet before spinal of anesthesia .
Primary Outcome Measure Information:
Title
Time to first requirement of analgesic supplement
Time Frame
Time to first requirement of analgesic supplement within 24 hours after intratechal injection
Title
amount of blood loss after cesarean delivery
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
hemodynamic variables
Time Frame
5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 min after the injection
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant women at term (37-40 wks) gestation scheduled for either elective or emergency lower segment cesarean section
Exclusion Criteria:
women with any risk factor associated with an increased risk of postpartum hemorrhage were excluded i.e. 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 ,anemia (Hb8 g%)or known coagulopathy
Facility Information:
Facility Name
Qazvin Medical Science University
City
Qazvin
ZIP/Postal Code
3419759811
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
31598047
Citation
Khezri MB, Reihany MD, Dabbaghi Ghaleh T, Mohammadi N. Effect of Melatonin on Blood Loss After Cesarean Section: A Prospective Randomized Double-Blind Trial. J Obstet Gynaecol India. 2019 Oct;69(5):436-443. doi: 10.1007/s13224-019-01205-7. Epub 2019 Apr 24.
Results Reference
derived
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Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section
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