Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
marzieh beigom khezri, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01572805
First received: April 3, 2012
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Post Partum Haemorrhage in Patients Undergoing Cesarean Section
Drug: melatonin 3mg
Drug: melatonin 6mg
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:
  • Time to first requirement of analgesic supplement [ Time Frame: Time to first requirement of analgesic supplement within 24 hours after intratechal injection ] [ Designated as safety issue: Yes ]
  • amount of blood loss after cesarean delivery [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hemodynamic variables [ Time Frame: 5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 min after the injection ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: melatonin 3mg Drug: melatonin 3mg
To receive sublingual 3 mg melatonin before spinal of anesthesia .
Active Comparator: melatonin 6mg Drug: melatonin 6mg
To receive sublingual 6 mg melatonin before spinal of anesthesia .
Placebo Comparator: placebo Drug: placebo
To receive sublingual placebo tablet before spinal of anesthesia .

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01572805

Locations
Iran, Islamic Republic of
Qazvin Medical Science University
Qazvin, Iran, Islamic Republic of, 3419759811
Sponsors and Collaborators
Qazvin University Of Medical Sciences
  More Information

No publications provided

Responsible Party: marzieh beigom khezri, Assistant professor, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT01572805     History of Changes
Other Study ID Numbers: ACTRN12612000117819
Study First Received: April 3, 2012
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Qazvin University Of Medical Sciences:
Post partum haemorrhage
Cesarean
Pain

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Obstetric Labor Complications
Pathologic Processes
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Melatonin
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014