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

NCT ID: NCT01572805

Last Updated: 2012-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Post Partum Haemorrhage in Patients Undergoing Cesarean Section

Keywords

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Post partum haemorrhage Cesarean Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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melatonin 3mg

Group Type ACTIVE_COMPARATOR

melatonin 3mg

Intervention Type DRUG

To receive sublingual 3 mg melatonin before spinal of anesthesia .

melatonin 6mg

Group Type ACTIVE_COMPARATOR

melatonin 6mg

Intervention Type DRUG

To receive sublingual 6 mg melatonin before spinal of anesthesia .

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

To receive sublingual placebo tablet before spinal of anesthesia .

Interventions

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melatonin 3mg

To receive sublingual 3 mg melatonin before spinal of anesthesia .

Intervention Type DRUG

melatonin 6mg

To receive sublingual 6 mg melatonin before spinal of anesthesia .

Intervention Type DRUG

placebo

To receive sublingual placebo tablet before spinal of anesthesia .

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Qazvin University Of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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marzieh beigom khezri

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qazvin Medical Science University

Qazvin, Qazvin Province, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 31598047 (View on PubMed)

Other Identifiers

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ACTRN12612000117819

Identifier Type: -

Identifier Source: org_study_id