Protocol summary
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Study aim
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Determining the effectiveness of nasal oxytocin on the prevention of post-dural pucture headache in women undergoing cesarean section
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Design
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2 Parallel groups with control group, double-blind, phase 3 on 170 patients, For randomization, the Random allocation software will be used.
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Settings and conduct
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1.The study will be performed in Kamali Hospital. Women who are candidates for elective cesarean section are admitted according to the inclusion criteria.
2. Exclusion of patients with exclusion criteria in pre-surgery visit by examination.
3. 170 women will be selected and They will be randomly divided into two groups.
5. Administration of 3 puffs (30IU) of nasal oxytocin to intervention group immediately after delivery, as a single dose and a dose of equal volume of normal saline, to the control group.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Elective cesarean section candidates,
Exclusion criteria:
Known allergy to any of the studied drugs,
Hepatic, renal, cardiac dysfunction,
Severe obesity (BMI more than 35),
Neuromuscular disease,
History of lumbar discopathy / history of neuropathy,
opioids or analgesic usage 3 days before the study,
Consumption of calcium channel blockers,
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Intervention groups
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Intervention group: Receiving of 3 puffs (30IU) Nasal oxytocin (alborz drug company, made in Iran) Immediately after delivery
Controll group: Receiving of 3 puffs Nasal saline Immediately after delivery
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Main outcome variables
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The severity of headache after spinal anesthesia
General information
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Reason for update
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Add the actual recruitment date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201215049725N1
Registration date:
2021-09-10, 1400/06/19
Registration timing:
registered_while_recruiting
Last update:
2022-08-17, 1401/05/26
Update count:
1
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Registration date
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2021-09-10, 1400/06/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-09-29, 1400/07/07
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Expected recruitment end date
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2021-10-13, 1400/07/21
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Actual recruitment start date
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2021-05-23, 1400/03/02
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Actual recruitment end date
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2021-09-15, 1400/06/24
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Trial completion date
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2021-09-18, 1400/06/27
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Scientific title
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Evaluation of Intranasal oxytocine spray effect on preventing post-dural puncture headache after elective cesarean section, A Clinical trial
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Public title
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Evaluation of Intranasal oxytocine spray effect on preventing post-dural puncture headache after cesarean section
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Elective cesarean candidates
Exclusion criteria:
Allergies to drugs used in this study
BMI more than 35
Hepatic, renal or cardiac disorder
Neuromuscular disease
History of lumbar discopathy / history of neuropathy
Opioids or analgesic usage 3 days before the study
Consumption of calcium channel blockers
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Age
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No age limit
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Gender
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Female
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
170
Actual sample size reached:
170
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A randomized list will be generated using block randomization method with non-identical blocks of 2, 4 and 6 in two groups. This list will be generated by the following web address: https://www.sealedenvelope.com/simple-randomiser/v1/lists
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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For blinding, placebo will be used in the control group which has exact similar appearance with the medicine used in the intervention group. The physician who assess the outcome will not be aware of the patient's groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-05-18, 1400/02/28
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Ethics committee reference number
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IR.ABZUMS.REC.1400.047
Health conditions studied
1
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Description of health condition studied
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post-dural puncture headache
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ICD-10 code
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O89.4
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ICD-10 code description
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Spinal and epidural anesthesia-induced headache during the puerperium
Primary outcomes
1
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Description
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headache severity after spinal anesthesia based on vas-score
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Timepoint
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12, 24, 48, 72 hours after cesarean section
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Method of measurement
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Visual Analogue Scale
Intervention groups
1
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Description
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Intervention group: After cesarean section, The intervention group is given 3-puff (30IU) nasal oxytocin (Alborz Drug Company, Made in Iran) as a single dose immediately after delivery.
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Category
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Prevention
2
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Description
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Control group: After cesarean section, The Control group is given 3-puff nasal saline, which its appearance is exactly similar to oxytocin, as a single dose immediately after delivery.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Karaj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable