Determine the effect of topical magnesium sulfate on cervical edema in women admitted to childbirth ward of Imam Khomeini Hospital of Divandareh in 2019.
Design
Randomized clinical trial
Settings and conduct
Maternity ward of Imam Khomeini hospital in Divandareh city
In the intervention group, 10% magnesium sulfate 10 cc will be topically applied to the cervix by the researcher through a 10 cc syringe. And if the cervical swelling does not improve after two hours, 10 cc of magnesium sulfate will be poured again on the cervix.The control group will receive 10 cc normal saline under the same conditions
Participants/Inclusion and exclusion criteria
Inclusion: Age 18-35 years, Primiparous, Gestational age 37-42, Cephalic presentation, Singleton, BMI 19.8-30, NST reactive, Willingness to participate in the study, History of severe dysmenorrhea, History of infertility, Narcotic use during pregnancy, Attend birth statistics classes
Exclusion: There are indications for cesarean section, Maternal withdrawal from continuing study
Intervention groups
In the intervention group, 50% magnesium sulfate vial will be applied topically to the cervix using a syringe.
The control group will receive normal saline as placebo.
Main outcome variables
Improve cervical edema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171210037807N2
Registration date:2019-12-12, 1398/09/21
Registration timing:prospective
Last update:2019-12-12, 1398/09/21
Update count:0
Registration date
2019-12-12, 1398/09/21
Registrant information
Name
sheno ghaderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 7228
Email address
ghaderi.sheno@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical magnesium sulfate on cervical edema in women admitted to childbirth ward of Imam Khomeini Hospital of Divandareh in 2019.
Public title
The effect of topical magnesium sulfate on cervical edema during labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-35 years
Primiparous
Gestational age 37-42
Cephalic presentation
Singleton
BMI 19.8-30
NST reactive
Willingness to participate in the study
A history of severe dysmenorrhea
History of infertility
Narcotic use during pregnancy
Attend birth statistics classes
Exclusion criteria:
There are indications for cesarean section
Maternal withdrawal from continuing study
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Using closed envelopes containing the letters A and B will be placed in one of the intervention (A) or control (B) groups, this will continue until the sample volume is completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Imam Khomeini Street
City
Divandarreh
Province
Kurdistan
Postal code
13446666147
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.MUK.REC.1398.185
Health conditions studied
1
Description of health condition studied
Cervical edema
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cervical edema
Timepoint
Vaginal examination every 2 hours
Method of measurement
Edema based on touch of fluid accumulation in the cervix (which changes the thickness and consistency of the cervix) will be considered by the researcher and improvement of cervical edema means swelling returns to normal.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using 50% magnesium sulfate vial made by Shahid Ghazi Pharmaceutical Company, The 50% magnesium sulfate 50 cc will be poured onto the cervix by the researcher through a 10 cc syringe. And if the cervical swelling does not improve after two hours, 10 cc of magnesium sulfate will be poured again on the cervix.
Category
Treatment - Drugs
2
Description
Control group:In the control group, 10 cc normal saline will be topically applied to the cervix by the researcher through a 10 cc syringe. And if the cervical swelling does not improve after two hours, 10 cc of normal saline will be poured on the cervix again.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Sheno Ghaderi
Street address
Imam Khomeini ِStreet
City
Divandarreh
Province
Kurdistan
Postal code
6648456485
Phone
+98 87 3872 2930
Email
Ghaderi.sheno1366sg@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sheno Ghaderi
Street address
Imam Khomeini Streeyt
City
Sanandaj
Province
Kurdistan
Postal code
13446666147
Phone
+98 87 3323 1458
Email
Ghaderi.sheno1366sg@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kurdistan 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
Sanandaj University of Medical Sciences
Full name of responsible person
Sheno ghaderi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Imam Khomeini Street
City
Divandareh
Province
Kurdistan
Postal code
6648456485
Phone
+98 87 3872 2930
Email
Ghaderi.sheno1366sg@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sheno Ghaderi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Imam Khomeini Street
City
Divandareh
Province
Kurdistan
Postal code
6648456485
Phone
+98 87 3872 2930
Email
Ghaderi.sheno1366sg@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sheno Ghaderi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Imam Khomeini Street
City
Divandareh
Province
Kurdistan
Postal code
6648456485
Phone
+98 87 3872 2930
Email
Ghaderi.sheno1366sg@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD