Evaluation of the effect of topical magnesium sulfate on cervical progression
Design
A controlled clinical trial with randomized double-blind randomized parallel groups was performed on 88 patients.
Settings and conduct
492/5000
Location of Asalian Hospital, Lorestan University of Medical Sciences, 88 eligible patients will be included in the present study. In this way, a part of the table of random numbers is selected and AB code is used for 0 to 4 numbers and BA code is used for 5 to 9 numbers. In this study, code A represents the group receiving magnesium sulfate and code B represents the placebo group.
Participants/Inclusion and exclusion criteria
Inclusion criteria for women between 18-35 years of age are primiparous, gestational age 37-42 full weeks live live single fetus with fetal head weight estimate between 2500-4000 g Spontaneous onset of labor process, low risk pregnancy and body mass index 8.19 -30 kg per square meter. Exclusion criteria: fetal heart rate abnormalities, placental abruption and umbilical cord prolapse.
Intervention groups
In the intervention group, after the onset of the active phase, which is dilated 3-5 cm with active uterine contractions and having a urine score of 5, the researcher pours 10 cc of 50% magnesium sulfate into the cervix from the fingertips with a 10 cc syringe by the examiner. . If a ruptured bladder is seen, 10 cc of magnesium sulfate is poured onto the cervix again. In the control group, distilled water is used instead of magnesium sulfate for blinding
Main outcome variables
Effect of magnesium sulfate on dilatation, effusion, cervical condition and cervical consistency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090701002114N5
Registration date:2020-09-07, 1399/06/17
Registration timing:prospective
Last update:2020-09-07, 1399/06/17
Update count:0
Registration date
2020-09-07, 1399/06/17
Registrant information
Name
Fatemeh Yari
Name of organization / entity
Lorestan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1222 6450
Email address
yari.f@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-10, 1399/06/20
Expected recruitment end date
2020-11-10, 1399/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the local effect of magnesium sulfate on cervical progression during labor in nulliparous women
Public title
Effect of magnesium sulfate on cervical progression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women
18-35 years old
Fetal age 37-42 full weeks
live single fetus
Estimated weight 2500-4000 gr
Spontaneous onset of the labor process
low risk pregnancy
body mass index 19/8-30
Exclusion criteria:
Uncertain pattern of fetal heart rate
Occurrence of placental abruption and umbilical cord prolapse's lack of patient cooperation and mismatch of fetal head with mother pelvis
umbilical cord prolapse's
lack of patient cooperation
cephalopelvic disappropriation Based on the diagnosis of the treating physician
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
using the randomized block method, in the form of quadruple blocks in two double-blind intervention groups And control will be assigned. In this way, a part of the table of random numbers is selected and AB code is used for 0 to 4 numbers and BA code is used for 5 to 9 numbers. In this study, code A represents the group receiving magnesium sulfate and code B represents the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the fact that in the intervention group, 10 cc of magnesium sulfate 50% will be used topically through the vagina using a syringe, in the control group, under the same conditions, only distilled water instead of magnesium sulfate drug for blinding The researcher and the patient will be used. It should be noted that vials that are completely similar to distilled water and magnesium sulfate drug without a drug name label will be used. These vials will be separated by a label containing a code (by a specific pharmaceutical company) that 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 committe of Lorestan University of Medical Sciences
Street address
university campus complex, km 3 of Khorramabad-Borujerd road, Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2020-08-05, 1399/05/15
Ethics committee reference number
IR.LUMS.REC.1399.86
Health conditions studied
1
Description of health condition studied
Labor progress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of magnesium sulfate on cervical effacement
Timepoint
Every two hours until the cervix is fully open
Method of measurement
Through internal examination of the vagina, which is expressed as a percentage
2
Description
The effect of magnesium sulfate on cervical dilatation
Timepoint
Every two hours until the cervix is fully open
Method of measurement
Through an internal vaginal examination expressed in centimeters
3
Description
Effect of magnesium sulfate on cervical position
Timepoint
Every two hours until the cervix is fully
Method of measurement
Through an internal vaginal examination expressed in centimeters
4
Description
Effect of magnesium sulfate on cervical consistency
Timepoint
Every two hours until the cervix is fully
Method of measurement
Soft to medium hard
5
Description
Effect of magnesium sulfate on cervical position
Timepoint
Every two hours until the cervix is fully
Method of measurement
Anterior posterior medial
Secondary outcomes
1
Description
Effect of magnesium sulfate on Bishab score
Timepoint
Every two hours
Method of measurement
In terms of score
2
Description
Effect of magnesium sulfate on the duration of labor
Timepoint
Every two hours
Method of measurement
per second
Intervention groups
1
Description
Intervention group:. In the intervention group, after the onset of the active phase, which is dilated 3-5 cm with active uterine contractions and having a urine score of 5, the researcher pours 10 cc of 50% magnesium sulfate into the cervix from the fingertips with a 10 cc syringe by the examiner. Be. If a ruptured bladder is seen, 10 cc of magnesium sulfate is poured on the cervix again.
Category
Treatment - Drugs
2
Description
Control group:, distilled water is used instead of magnesium sulfate for blinding
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Asalian Hospital
Full name of responsible person
Dr. Masoumeh Ghaffarzadeh
Street address
Palestine Alley, 14 Asalian Hospital
City
khorramabad
Province
Lorestan
Postal code
6818795895
Phone
+98 66 3340 6099
Email
asali.hospital@lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ebrahim Falahi
Street address
Kamalvand, km 4 of Khorramabad-Borujerd road, medical school
City
khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0172
Email
Medicine@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
dr.fateme yari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Kamalvand - 4 km of Khorramabad-Borujerd road, medical school
City
khorramabad
Province
Lorestan
Postal code
381351698
Phone
009833120133
Email
yari.f@lums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
dr.fateme yari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Kamalvand, km 4, Khorramabad-Borujerd road, medical school
City
khorramabad
Province
Lorestan
Postal code
381351698
Phone
009833120133
Email
yari.f@lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
fateme yari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Kamalvand, km 4, Khorramabad-Borujerd road, medical school
City
khorramabad
Province
Lorestan
Postal code
0098381351698
Phone
009833120133
Email
yari.f@lums.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
It is possible to share all the data while maintaining the principle of not mentioning the names of individuals
When the data will become available and for how long
One year after the publication of the related article
To whom data/document is available
Researchers of university centers
Under which criteria data/document could be used
The data of the present study can be used after obtaining permission and approval from the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences
From where data/document is obtainable
Refer to the project manager, Dr. Fatemeh Yari, with email address yari1672@yahoo.com, and contact number 09163613621
What processes are involved for a request to access data/document
After completing the research and publishing the relevant article, individuals can apply to the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences to receive documents and after obtaining permission from this department, send a confirmation from the Vice Chancellor for Research to the project manager. Can access documentation.