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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| melatonin 3mg | Active Comparator |
| |
| melatonin 6mg | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| melatonin 3mg | Drug | To receive sublingual 3 mg melatonin before spinal of anesthesia . |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first requirement of analgesic supplement | Time to first requirement of analgesic supplement within 24 hours after intratechal injection | |
| amount of blood loss after cesarean delivery | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| hemodynamic variables | 5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 min after the injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qazvin Medical Science University | Qazvin | Qazvin Province | 3419759811 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31598047 | Derived | 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. |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| melatonin 6mg |
| Drug |
To receive sublingual 6 mg melatonin before spinal of anesthesia . |
|
| placebo | Drug | To receive sublingual placebo tablet before spinal of anesthesia . |
|
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |