Evaluating the effects of topical magnesium sulfate on the active phase and progression of labor in nulliparous women
Design
A controlled clinical trial with randomized double-blind randomized parallel groups is performed on 74 patients.
Settings and conduct
Study place is Kamali educational clinical center .In order to prepare patient's randomly allocated successions, it was placed in sealed envelopes that are designated in 5 digit serial numbers, by a third person who is not involved in the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnant women with gestational age of 37 to 42 weeks
first labor
single fetus weighting between 3.5 - 4 kg
low risk, non-induced labor
BMI of the mother being between 19.8 and 30 kg/m2
exclusion criteria: any sign indicating fetal heart rate abnormalities, placenta abruption, cord prolapse or anything that pregnancy is high risk
cephalopelvic disproportion mothers' chronic underlying disease like anemia, hemophilia, cardiopulmonary or neuromuscular disease any sign of allergy or toxicity caused by magnesium sulfate
Intervention groups
Intervention group: 10 cc of 50% topical magnesium sulfate solution is poured by a 10 cc syringe through the fingers and completely covers the cervix.
Control group: Control group which does not receive magnesium sulfate, their data is collected for comparison with the intervention group.
Main outcome variables
Fetal station-Cervical dilation-Cervical effacement-Cervical consistency-Cervical position-Bishop score-length of the active phase of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201024049128N3
Registration date:2021-08-09, 1400/05/18
Registration timing:registered_while_recruiting
Last update:2021-08-09, 1400/05/18
Update count:0
Registration date
2021-08-09, 1400/05/18
Registrant information
Name
Bita Badehnoosh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3222 2021
Email address
badehnoosh@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of topical magnesium sulfate on the active phase and progression of labor in nulliparous women
Public title
Effects of topical magnesium sulfate on progression of labor
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with gestational age of 37 to 42 weeks
First labor
Single fetus weighting between 3.5 - 4 kg
Low risk, non-induced labor
BMI of the mother being between 19.8 and 30 kg/m2
Exclusion criteria:
Any sign indicating fetal heart rate abnormalities, placenta abruption, cord prolapse or anything that pregnancy is high risk
Cephalopelvic disproportion
Mothers' chronic underlying disease like anemia, hemophilia, cardiopulmonary or neuromuscular disease
Any sign of allergy or toxicity caused by magnesium sulfate
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are recruited in from referred clientele of Kamali hospital that have inclusion criteria. 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 control group. This randomization are done with Random number generator command of STATA software until reaching determined sample size . In this special randomized study people are categorized in control and study group with technique of Balanced block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to prepare patient's randomly allocated successions, it was placed in sealed envelopes that are designated in 5 digit serial numbers, by a third person who is not involved in the trial. All the envelopes carry this 5 digit serial number and are opened immediately after completion of patient's work-up and basic lab tests and thus categorize them into intervention and control groups. No patient is aware of another's progression or outcome.
Placebo
Not 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
Research and Development Department of Alborz University of Medical Sciences, Safarian Ave, 45 Metri Blvd, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.ABZUMS.REC.1400.004
Health conditions studied
1
Description of health condition studied
Active phase and progression of Labor in nulliparous women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fetal station
Timepoint
Every 2 hours until the end of active phase of labor
Method of measurement
Physical examination and recording the data on questionnaire
2
Description
Cervical dilation
Timepoint
Every 2 hours until the end of active phase of labor
Method of measurement
Physical examination and recording the data on questionnaire
3
Description
Cervical effacement
Timepoint
Every 2 hours until the end of active phase of labor
Method of measurement
Physical examination and recording the data on questionnaire
4
Description
Cervical consistency
Timepoint
Every 2 hours until the end of active phase of labor
Method of measurement
Physical examination and recording the data on questionnaire
5
Description
Cervical position
Timepoint
Every 2 hours until the end of active phase of labor
Method of measurement
Physical examination and recording the data on questionnaire
6
Description
Bishop score
Timepoint
Every 2 hours until the end of active phase of labor
Method of measurement
Calculated by adding up the scores of the first 5 variables, maximum score of15
7
Description
Length of the active phase of labor
Timepoint
Every 2 hours until the end of active phase of labor
Method of measurement
Physical examination and recording the data on questionnaire
Secondary outcomes
empty
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 Bishop 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 on the cervix again. Generic drug used is magnesium sulfate injection parenteral 10 % 50milliliter (infu-magnesol); made by shahid ghazi pharmaceuticals company; IRC 6210969267810048.
Category
Treatment - Drugs
2
Description
Control group : we perform no special intervention on them just measure the above mentioned factors without magnesium sulphate.Then the data are comprised with the data of intevention group after entering in the analyzing program.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali Hospital
Full name of responsible person
Bita Badehnoosh
Street address
Kamali Hospital; Kamali Alley; Shohada Square; Shahid Beheshti Street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz 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
Alborz 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
Alborz University of Medical Science
Full name of responsible person
Reza Rakhshafar
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Kamali Hospital; Kamali Alley; Shohada Square; Shahid Beheshti Street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
rakhshafar.reza@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Bita Badehnoosh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali Hospital; Kamali Alley; Shohada Square; Shahid Beheshti Street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
b_badehnoosh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Science
Full name of responsible person
Reza Rakhshafar
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Kamali Hospital; Kamali Alley; Shohada Square; Shahid Beheshti Street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
rakhshafar.reza@gmail.com
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