Effect of oral magnesium sachet versus placebo on treatment of post-dural puncture headache in pregnant women candidate for cesarean section: a double-blind randomized clinical trial
To assess the effect of oral magnesium sachet versus placebo on treatment of post-dural puncture headache in pregnant women candidate for cesarean section
Design
This is a double-blind randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Fatemieh Hospital in Hamadan city on 130 eligible pregnant women candidate for cesarean section. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 15 to 45 years
Pregnant women candidate for cesarean section
Exclusion criteria:
Preeclampsia
History of chronic headache
Renal failure
Intervention groups
Intervention group:
Magnesium sachet 400 mg once a day for 3 days
Control group:
Placebo sachet once a day for 3 days
Main outcome variables
Primary outcome:
Headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N433
Registration date:2022-07-06, 1401/04/15
Registration timing:prospective
Last update:2022-07-06, 1401/04/15
Update count:0
Registration date
2022-07-06, 1401/04/15
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral magnesium sachet versus placebo on treatment of post-dural puncture headache in pregnant women candidate for cesarean section: a double-blind randomized clinical trial
Public title
Effect of oral magnesium sachet versus placebo on treatment of post-dural puncture headache in pregnant women candidate for cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 15 to 45 years
Pregnant women candidate for cesarean section
Exclusion criteria:
Preeclampsia
History of chronic headache
Renal failure
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-06-25, 1401/04/04
Ethics committee reference number
IR.UMSHA.REC.1401.225
Health conditions studied
1
Description of health condition studied
Headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
Headache
Timepoint
On the first, third and fifth days after cesarean section
Method of measurement
Using Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Magnesium sachet 400 mg once a day for 3 days
Category
Treatment - Drugs
2
Description
Control group: Placebo sachet once a day for 3 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Kamran Borhani Naeini
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
kamranborhani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Kamran Borhani Naeini
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
kamranborhani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mahshid Nikooseresht
Position
Anesthesiologist
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
nikoo_mahshid@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available