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

Sponsor

Qazvin University Of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01572805

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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

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 or Disease	Intervention/Treatment	Phase
Post Partum Haemorrhage in Patients Undergoing Cesarean Section	Drug: melatonin 3mg Drug: melatonin 6mg Drug: placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 .

Arm

Intervention/Treatment

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 .

Outcome Measures

Primary Outcome Measures

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

hemodynamic variables [5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 min after the injection]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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