Determining and comparing the progression of effacement, cervical dilatation and duration of labor in magnesium sulfate group and control before and after the intervention
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 98 pregnant women. Random number table was used for randomization.
Settings and conduct
In this double-blind clinical trial, 98 nulliparous women with term pregnancy referred to Kosar Hospital in Qazvin. Participants were randomly divided into two groups of 49 people. In the intervention group, 10 cc of 50% magnesium sulfate is poured on the cervix from the fingertips of the examiner during vaginal examination so that the whole cervix is covered with it. In the second group, distilled water is used in the same way. In order to blind the participants in the control group, distilled water is used instead of magnesium sulfate.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mother age between 18 until 35 years; Being primiparous; Full gestational age 37-42 weeks; Live single fetus; Spontaneous start of the labor process
Exclusion criteria: History of infertility; Having risky underlying diseases
Intervention groups
In one group, the whole cervix is impregnated with 50% magnesium sulfate through a 10 cc syringe during vaginal examination, and in the other group, distilled water is used in the same way.
Main outcome variables
Dilatation, effacement, duration of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120428009576N5
Registration date:2021-01-18, 1399/10/29
Registration timing:registered_while_recruiting
Last update:2021-01-18, 1399/10/29
Update count:0
Registration date
2021-01-18, 1399/10/29
Registrant information
Name
Ezzatsadat Haji seyed javadi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3223 6374
Email address
ehajiseyedjavadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical magnesium sulfate on the progression of effacement, dilatation and duration of labor in nullipar women
Public title
The effect of topical magnesium sulfate on the progression of effacement, dilatation and duration of labor in nullipar women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mother age between 18 until 35 years
Being primiparous
Full gestational age 37-42 weeks
Live single fetus with head display and estimated weight 2500-4000 grams
Spontaneous start of the labor process
Body mass index 19.8-30 kg per square meter
Exclusion criteria:
History of infertility
Having risky underlying diseases (heart disease, lung disease, connective tissue and smooth muscle problems, and fetal head incompatibility with the mother's pelvis)
Fetal heart rate problems
Incidence of placental abruption and umbilical cord prolapse
Patient non-cooperation
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization was performed using a table of random numbers. First, a number of numbers were randomly placed in the table and specified by the researcher to read the numbers from top to bottom in the table, then even numbers were used for intervention A and odd numbers were used for intervention B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Considering that in the intervention group, 10 cc of 50% magnesium sulfate will be applied topically through the vagina using a syringe, In the control group, under the same conditions, only distilled water will be used instead of magnesium sulfate to blind the researcher and the patient. It should be noted that completely identical vials of distilled water and magnesium sulfate will be used without the drug name label. These vials will be separated by a label containing a code, and the researcher is completely unaware of their nature.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2020-12-26, 1399/10/06
Ethics committee reference number
IR.QUMS.REC.1399.363
Health conditions studied
1
Description of health condition studied
labor progress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cervical effacement
Timepoint
At the beginning of the active phase and then every two hours
Method of measurement
Through vaginal examination
2
Description
Cervical dilatation
Timepoint
At the beginning of the active phase and then every two hours
Method of measurement
Through vaginal examination
Secondary outcomes
1
Description
Type of delivery
Timepoint
After delivery
Method of measurement
View and record in the file
2
Description
Duration of labor
Timepoint
Every two hours
Method of measurement
Per second
3
Description
Apgar score
Timepoint
Every two hours
Method of measurement
In terms of score
4
Description
Hemoglobin
Timepoint
Six hours after delivery
Method of measurement
Blood test
5
Description
Postpartum hemorrhage and rupture of the birth canal
Timepoint
After delivery
Method of measurement
Blood tests and examination
Intervention groups
1
Description
Intervention group: In the intervention group, after detecting the active phase with dilation of 3-5 cm, 10 cc of 50% magnesium sulfate made by Shahid Ghazi Pharmaceutical Company of Tabriz-Iran with serial number 3138 is poured on the cervix during vaginal examination, so that the whole cervix is impregnated with it. In addition, in order to better absorb the drug, the mother will be asked to stay in bed for half an hour after taking the drug.
Category
Treatment - Drugs
2
Description
Control group: In the control group, after detecting the active phase with dilation of 3-5 cm, 10 cc of distilled water is poured on the cervix during vaginal examination, so that the whole cervix is impregnated with it. In addition, in order to better absorb the drug, the mother will be asked to stay in bed for half an hour after taking the drug.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Azin Yazdani
Street address
Kosar Hospital, Taleghani St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
34156-13176
Phone
+98 28 3323 6374
Email
azin_y6583@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mohammad Mahdi Emamjomeh
Street address
Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 6001
Fax
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Azin Yazdani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 6001
Email
azin_y6583@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Ezzatalsadat Haji Seid Javadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kosar Hospital, Taleghani St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
13176- 34156
Phone
+98 28 3323 6374
Email
dr_seidjavadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Azin Yazdani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kosar Hospital, Taleghani St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
13176- 34156
Phone
+98 28 3323 6374
Email
azin_y6583@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The collected information is in the form of a questionnaire and is statistically analyzed.
When the data will become available and for how long
The start of the access period is one year after the results are published.
To whom data/document is available
For obstetricians and researchers working in academic institutions
Under which criteria data/document could be used
Evaluate the path and process of study and analyze it
From where data/document is obtainable
For information, refer to Dr. Azin Yazdani. The communication channels are as follows:
By sending an email to the address:
azin_y6583@yahoo.com or refer and contact Kosar Hospital at the address: Qazvin, Taleghani St. Phone: 028-33236374 Postal address: 34156-13176
What processes are involved for a request to access data/document
After sending the e-mail, the requested information will be reviewed by the facilitator and the person responsible for the scientific response of the study. At your discretion, the requested information will be sent within 10 days after receiving the email.