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

Phase 1

Completed

• Conditions: Post Partum Haemorrhage in Patients Undergoing Cesarean Section
• Interventions: Drug: melatonin 3mg; Drug: melatonin 6mg; Drug: placebo

• Registration Number: NCT01572805
• Lead Sponsor: Qazvin University Of Medical Sciences

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Primary Completion: 2012-09
• Status Verified: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
melatonin 3mg	melatonin 3mg	-
melatonin 6mg	melatonin 6mg	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
hemodynamic variables	5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 min after the injection

Trial Locations

Locations (1)

Qazvin Medical Science University; 🇮🇷 Qazvin, Iran, Islamic Republic of