Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section
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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 |
- 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 ]
- 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 |
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 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 Pathologic Processes Obstetric Labor Complications Pregnancy Complications Puerperal Disorders Uterine Hemorrhage Melatonin |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013