Investigating the effect of vaginal magnesium sulfate in preparing the cervix before labor induction
Design
A clinical trial with a control group, with parallel groups, three blinded, randomized, phase 3 on 104 patients. Computer random assignment software was used for randomization.
Settings and conduct
The study is a triple-blinded clinical trial in Imam Khomeini and Razi Hospitals in Ahvaz. Completely similar vials containing normal saline and magnesium sulfate will be used without drug labels. These vials will be labeled with an A or B code by a research colleague. They will be separated from each other and the patient and the examiner and the researcher and the analyst will be completely unaware of its nature.
In the initial examination, Bishop's score will be determined for the patient, then cotton soaked with 5cc of vial A or B is placed in the patient's cervix, and 3 hours later, the patient will be examined again and the secondary Bishop's score will be determined. The duration of labor and the active phase of labor are measured in each patient
Participants/Inclusion and exclusion criteria
Pregnant women 18_35 years
BMI:19.8 _30
Gestational age 34_42 week by first trimesther sonograghy
A single alive fetus with cephalic presentation and 2500 _4000 gr by sonograghy
Bishop score below 5
Having Indication of labor induction
The exclusion criteria :contraindications for induction of labor and lack of consent to participate in the study
Intervention groups
Control group:Cotton soaked in 5 cc of normal saline will be placed in the patient's vagina
Intervention group:Cotton soaked in 5 cc of magnesium sulfate will be placed in the patient's vagina
Main outcome variables
Primary and secondary Bishop score, type of labor, total length of labor, length of the active phase of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230612058462N1
Registration date:2023-10-09, 1402/07/17
Registration timing:registered_while_recruiting
Last update:2023-10-09, 1402/07/17
Update count:0
Registration date
2023-10-09, 1402/07/17
Registrant information
Name
Ayeh Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 4753
Email address
s.r.musavi88@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-20, 1402/05/29
Expected recruitment end date
2024-04-17, 1403/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of vaginal magnesium sulfate in preparing the cervix before labor induction
Public title
The effect of vaginal magnesium sulfate in preparing the cervix before labor induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women 18_35 years
BMI :19/8 _30
Gestational age 34_42 week by first trimester sonograghy
A single alive fetus with cephalic presentation and 2500_4000 gr by sonograghy
Having a Indication to labor induction
Exclusion criteria:
Having indications for cesarean section
Lack of consent to participate in the study
Having a history of cesarean section
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups of 52 people, A and B, using random assignment computer software, and the number of groups and samples are recorded in this software, and people are randomly assigned to two groups. The randomization list will be determined by the statistician.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study will be conducted in a triple-blind manner. Completely similar vials containing normal saline (placebo or placebo) and magnesium sulfate will be used without drug labels. These vials will be labeled with an A or B code by another research colleague. They will be separated from each other and the patient and the examiner and the researcher and the analyst will be completely unaware of its nature.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Ahvaz University of medical science
Street address
Ahvaz - Golestan - Koi Saadi - East Torbat Street - Plate 131
City
Ahwaz
Province
Khouzestan
Postal code
٦١٣٦٦٨٥٤٧٧
Approval date
2023-08-25, 1402/06/03
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1402.029
Health conditions studied
1
Description of health condition studied
The effect of vaginal magnesium sulfate in preparing the cervix before induction of labor
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bishop score
Timepoint
Before intervention and after 3 hours
Method of measurement
According to Bishop score
2
Description
Total time of vaginal delivery
Timepoint
Since start labor induction till vaginal delivery
Method of measurement
Clock
3
Description
Time of active phase of labor
Timepoint
Since cervix dilatation 4cm till vaginal delivery
Method of measurement
Clock
4
Description
Type of delivery
Timepoint
After delivery
Method of measurement
View and Record file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Completely similar vials containing normal saline ( placebo) and 50% magnesium sulfate from Shahid Ghazi Pharmaceutical Company of Tabriz, which are without drug labels, will be used. These vials will be labeled with an A or B code by another research colleague They will be separated, and the patient and the examiner, the researcher and the analyst will be completely unaware of its nature. In the initial examination, Bishop's score will be determined for the patient, then cotton soaked with 5 cc of vial A or B will be placed in the patient's cervix. 3 hours later, the patient will be examined again and the secondary Bishop score will be determined. Also, by entering the relevant code in the partograph form, the duration of labor and the active phase of labor were measured in each patient.
Category
Treatment - Drugs
2
Description
Control group: : Completely similar vials containing normal saline (placebo) and 50% magnesium sulfate from Shahid Ghazi Pharmaceutical Company of Tabriz, which are without drug labels, will be used. These vials will be labeled with an A or B code by another research colleague They will be separated, and the patient and the examiner, the researcher and the analyst will be completely unaware of its nature. In the initial examination, Bishop's score will be determined for the patient, then cotton soaked with 5 cc of vial A or B will be placed in the patient's cervix. 3 hours later, the patient will be examined again and the secondary Bishop score will be determined. Also, by entering the relevant code in the partograph form, the duration of labor and the active phase of labor were measured in each patient.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Seyede ayeh musavi
Street address
No.131،East torbat Ave،Quii saadi
City
Ahwaz
Province
Khouzestan
Postal code
۶۱۳۶۶۸۵۴۷۷
Phone
+98 61 3292 3985
Email
S.r.musavi88@gmail.com
Web page address
https://www.ajums.ac.ir/
2
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Seyede ayeh musavi
Street address
No.131،East torbat Ave،Quii saadi
City
Ahwaz
Province
Khouzestan
Postal code
۶۱۳۶۶۸۵۴۷۷
Phone
+98 61 3292 3985
Email
S.r.musavi88@gmail.com
Web page address
https://www.ajums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Doctor amir amani
Street address
No 131.East torbat،Quii saadi
City
Ahwaz
Province
Khouzestan
Postal code
۶۱۳۶۶۸۵۴۷۷
Phone
+98 61 3292 3985
Email
S.r.musavi88@gmail.com
Web page address
https://www.ajums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Seyede ayeh musavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
NO. 131 ،East Torbat Ave، saadi Qii
City
Ahwaz
Province
Khouzestan
Postal code
۶۱۳۶۶۸۵۴۷۷
Phone
+98 61 3337 4753
Fax
Email
S.r.musavi88@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyede ayeh musavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
NO. 131 ،East Torbat Ave، saadi Qii
City
Ahwaz
Province
Khouzestan
Postal code
۶۱۳۶۶۸۵۴۷۷
Phone
+98 61 3337 4753
Fax
Email
S.r.musavi88@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyede ayeh musavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
NO. 131 ،East Torbat Ave، saadi Qii
City
Ahwaz
Province
Khouzestan
Postal code
۶۱۳۶۶۸۵۴۷۷
Phone
+98 61 3337 4753
Fax
Email
S.r.musavi88@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Data related to the main outcome of the study
When the data will become available and for how long
1 year after the publication of the article
To whom data/document is available
Medical students and gynecologists
Under which criteria data/document could be used
Request through personal email - use for academic research
From where data/document is obtainable
The applicant should send an email to the research unit of the university, after explaining the working method, the necessary information will be sent
What processes are involved for a request to access data/document
Email your request to the research unit of the university and give a brief explanation about your work method or the details required from this study so that the details will be sent via email.