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

NCT01572805 | Completed Phase 1 DMC

• 1 other identifier: ACTRN12612000117819
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Post Partum Haemorrhage in Patients Undergoing Cesarean Section

Keywords

Post partum haemorrhage; Cesarean; Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• hemodynamic variables

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

Study Arms (3)

melatonin 3mg

ACTIVE COMPARATOR

Drug: melatonin 3mg

melatonin 6mg

ACTIVE COMPARATOR

Drug: melatonin 6mg

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

melatonin 3mg DRUG

To receive sublingual 3 mg melatonin before spinal of anesthesia .

melatonin 3mg

melatonin 6mg DRUG

To receive sublingual 6 mg melatonin before spinal of anesthesia .

melatonin 6mg

placebo DRUG

To receive sublingual placebo tablet before spinal of anesthesia .

placebo

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women at term (37-40 wks) gestation scheduled for either elective or emergency lower segment cesarean section

You may not qualify if:

• 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

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (1)

Qazvin Medical Science University

Qazvin, Qazvin Province, 3419759811, Iran

Location

Related Publications (1)

• 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.

  PMID: 31598047 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage; Pain

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 6, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

IR (1)