Comparison of nifedipine and magnesium sulfate in the treatment of preterm labor
Design
Clinical trial with two intervention groups, double-blind, randomized, phase 2 on 100 pregnant women with a gestational age of 28-34 weeks and with preterm labor pain
Settings and conduct
The study site was the maternity ward of Imam Khomeini Hospital in Ahvaz.
Blinding has been of the double-blind type.
In this study for blinding, one group receives nifedipine in addition to oral Ringer serum and one group receives magnesium sulfate in addition to placebo, and thus the patient and the doctor and the treatment staff of the patients do not know which participant belongs to which group.
Participants/Inclusion and exclusion criteria
Inclusion criterion: Single pregnancy with a gestational age of 28 to 34 weeks in the latent phase of labor
Exclusion criterion: Any situation that is inconsistent with continuing the pregnancy and receiving medication
Intervention groups
Intervention group 1: receiving nifedipine with a sample size of 50 people. Intervention group 2: receiving magnesium sulfate with a sample size of 50 people
Main outcome variables
Delaying delivery time with minimal side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201017049052N1
Registration date:2020-11-23, 1399/09/03
Registration timing:retrospective
Last update:2020-11-23, 1399/09/03
Update count:0
Registration date
2020-11-23, 1399/09/03
Registrant information
Name
Mina Mahdavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 6318
Email address
mina.m349@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-01, 1398/03/11
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2020-03-18, 1398/12/28
Trial completion date
2020-03-18, 1398/12/28
Scientific title
Comparison of magnesium sulfate and nifedipine in treatment of preterm labor in pregnant women with 28-34 weeks of gestational age.
Public title
Effect of magnesium sulfate and nifedipine in preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single fetus pregnancy
Pregnancy in 28_34 weeks of gestational age
Not in the active phase of labor
No contraindication to continue pregnancy
Exclusion criteria:
Any situation that makes it impossible to continue the pregnancy
Contraindications to the use of Nifedipin or Magnesium sulfate in the patient
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomisation of the random allocation role type, This method represents a large block for the entire sample size, This means that a balance in the number of people assigned to each group will be achieved at the end of the study.
For this purpose, it first determines a total sample size and then randomly assigns a set of them to group A and the remainder to group B.This method is used for two or more group trials.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blindness, the nifedipine group received Ringer serum in addition to oral medication and the magnesium sulfate group received oral placebo in addition to the injectable drug, and thus the patient, physician, and treatment staff of the patients under study have no knowledge of allocation of individuals to the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Unit 10, Tara Building, No 75, Second Phase, 2nd West St., Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
61558-19619
Approval date
2019-05-31, 1398/03/10
Ethics committee reference number
IR.AJUMS.REC.1398.186
Health conditions studied
1
Description of health condition studied
Preterm Labor
ICD-10 code
O60.00
ICD-10 code description
Preterm labor without delivery, unspecified trimester
Primary outcomes
1
Description
Delaying preterm delivery for more than 48 hours
Timepoint
Measurement of dilatation and effaceman of the cervix before treatment and 24 hours and 48 hours after treatment
Method of measurement
Manual vaginal examination
Secondary outcomes
1
Description
Drug side effects
Timepoint
Frequently after starting treatment until the end of the dose
Method of measurement
Patient statement and questionnaire
Intervention groups
1
Description
Intervention group 1: Nifidipine recipient with an initial dose of 20 mg orally and then every 6 hours for 24 hours
Category
Treatment - Drugs
2
Description
Intervention group 2: Recipient of 20% magnesium sulfate with an initial dose of 4 gram intravenously and then 2 gram per hour for 24 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahvaz
Full name of responsible person
Mina Mahdavi
Street address
Unit 10, Tara Building, No 75, Second Phase, 2nd West St., Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
61558-19619
Phone
+98 61 3337 6318
Email
mina.m349@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Karandish
Street address
Ahvaz Jundishapur University of Medical Sciences,Farvardin St., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61558-19619
Phone
+98 61 3337 6318
Email
mina.m349@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Mahdavi
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Unit 10,Tara Building, No 75, Second Phase, 2nd West St., Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
61558-19619
Phone
+98 61 3337 6318
Email
mina.m349@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Shahbazian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital; Azadegan street
City
Ahvaz
Province
Khouzestan
Postal code
61936-73111
Phone
+98 61 3222 2922
Email
nahid.shahbazian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Mahdavi
Position
Asistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Unit 10, Tara Building, No 75, Second Phase, 2nd West St., Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
61558-19619
Phone
+98 61 3337 6318
Email
mina.m349@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
No - There is not 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
Title and more details about the data/document
All data of study participants can be shared after making people and the entire study protocol unidentifiable.
When the data will become available and for how long
After publishing the results under the title of dissertation and also after registering in the Behsan system of Ahvaz Jundishapur University of Medical Sciences
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of all study materials without mentioning the source is unrestricted.
From where data/document is obtainable
Central Library of Ahvaz Jundishapur University of Medical Sciences
WWW.centrallib.ajums.ac.ir
What processes are involved for a request to access data/document
Access to the dissertation section is easily possible through the Central Library website.