Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01572805|
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : October 11, 2012
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||February 2012|
|Primary Completion Date :||September 2012|
|Study Completion Date :||October 2012|
|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||
To receive sublingual placebo tablet before spinal of anesthesia .
- Time to first requirement of analgesic supplement [ Time Frame: Time to first requirement of analgesic supplement within 24 hours after intratechal injection ]
- amount of blood loss after cesarean delivery [ Time Frame: during surgery ]
- hemodynamic variables [ Time Frame: 5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 min after the injection ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572805
|Iran, Islamic Republic of|
|Qazvin Medical Science University|
|Qazvin, Iran, Islamic Republic of, 3419759811|