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The effect of topical magnesium sulfate compared with topical normal saline on the cervix in the progression of labor : a randomized clinical trial

Protocol summary

Study aim
Determining the effect of topical magnesium sulfate on the cervix in the progression of labor : A clinical trial
Design
Two arm parallel group randomized trial with 100 pregnant women in each group, randomized with block randomization method
Settings and conduct
This study will be performed in labor ward , Kamali hospital, Karj on all women candidates for normal delivery who are eligible for the study. Patients who have consciously signed a consent form to participate in the project will be randomly assigned to two groups. The randomization list will be prepared by the statistician. Treatments will be placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure will be explained to her and informed consent will be obtained. Completing the final information is the responsibility of the person who is unaware of the type of treatment. The statistician will also be kept blind
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant woman candidate for vaginal birth, primigravida gestational age>= 38 weeks; Non-inclusion criteria: Indications for cesarean section including failure to progress, cessation of labor, decreased heart rate, bleeding and cleft palate, placenta abruption, fever, and chorioamnionitis, underlying diseases such as diabetes and hypertension, Preeclampsia and eclampsiae
Intervention groups
Intervention group: They will received 5 cc magnesium sulfate 50%, topically on the cervix in the latent and active phase of labor. Control group: They will received 5 cc normal saline, topically on the cervix in the latent and active phase of labor
Main outcome variables
Duration of labor, changes in Bishop score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210127050156N2
Registration date: 2021-12-06, 1400/09/15
Registration timing: prospective

Last update: 2021-12-06, 1400/09/15
Update count: 0
Registration date
2021-12-06, 1400/09/15
Registrant information
Name
Masoumeh Farahani
Name of organization / entity
The Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 5627
Email address
m.farahanii@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical magnesium sulfate compared with topical normal saline on the cervix in the progression of labor : a randomized clinical trial
Public title
The effect of topical magnesium sulfate on the cervix in the development of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant woman candidate for vaginal birth primigravid gestational age>= 38 weeks
Exclusion criteria:
Indications for cesarean section include failure to progress, cessation of labor, decreased heart rate, bleeding and cleft palate, placenta abruption , fever, and chorioamnionitis Underlying diseases such as diabetes and hypertension Preeclampsia Eclampsia
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Pregnant women who consented to participate were randomly selected to receive either Magnesium sulfate or Normal Saline . The block randomization method will be designed by using "www.sealedenvelope.com". The size of blocks is 4.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The randomization list will be prepared by the statistician. Treatments will be placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure will be explained to her and informed consent will be obtained. Completing the final information is the responsibility of the person who is unaware of the type of treatment. The statistician will also be kept blind
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Tehran
Postal code
3149779453
Approval date
2021-10-25, 1400/08/03
Ethics committee reference number
IR.ABZUMS.REC.1400.199

Health conditions studied

1

Description of health condition studied
labor
ICD-10 code
----
ICD-10 code description
----

Primary outcomes

1

Description
Duration of labor
Timepoint
After delivery
Method of measurement
Stopwatch

2

Description
Bishop Score changes
Timepoint
Every two hours until delivery
Method of measurement
Score Bishop Curve

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:They will received 5 cc magnesium sulfate 50%, topically on the cervix in the latent and also in the active phase of labor
Category
Treatment - Drugs

2

Description
Control group: They will received 5 cc normal saline, topically on the cervix in the latent and also in the active phase of labor
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Masoomeh Farahani
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Tehran
Postal code
3149779453
Phone
+98 26 3222 2021
Email
m.farahanii@abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Nourisepehr
Street address
Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Masoumeh Farahani
Position
Professor assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.51, Eastern 14 Ave., Northern Allameh Ave., Saadatabad
City
Tehran
Province
Tehran
Postal code
3149779453
Phone
+98 21 2236 5627
Fax
Email
m.farahanii@abzums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Masoumeh Farahani
Position
Professor assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.51, Eastern 14 Ave., Northern Allameh Ave., Saadatabad
City
Tehran
Province
Tehran
Postal code
3149779453
Phone
+98 21 2236 5627
Fax
Email
m.farahanii@abzums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Masoumeh Farahani
Position
Professor assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.51, Eastern 14 Ave., Northern Allameh Ave., Saadatabad
City
Tehran
Province
Tehran
Postal code
3149779453
Phone
+98 21 2236 5627
Fax
Email
m.farahanii@abzums.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
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