This is a randomized single-blind and two centers clinical trial. The aim of this study is to compare the effect of Niphedipin and magnesium sulfate on labor pain. Our sample size is 200 who are enrolled in the study based on inclusion criteria including singleton pregnancy, gestational age32-34 weeks, 30 second contractions and one contraction in 10 minutes at least .Exclusion criteria include Underlying medical condition, severe preeclampsia, intrauterine infections and congenital anomalies. Patients are randomly allocated into 2 groups. Before treatment both groups are hydrated with 1 liter Ringer serum. In the first group 4 grams magnesium sulfate in 200 cc Ringer serum is infused during 20 minutes and then 2 grams magnesium sulfate is infused per hour and continued up to 24 hours or 2 hours after contraction. Urine volume, respiration rate and patellar reflex are assessed every 4 hours during infusion.
In second group, 10 mg oralNifedipin is administered and if contractions continue for 15 minutes, the second dose is administered and continued every quarter of an hour for 1 hour. Then a 10 mg Nifedipin capsule per 6 hours is administered and continued to 24 hours. Then, the amount of uterine contractions is compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120711020N8
Registration date:2017-02-25, 1395/12/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-25, 1395/12/07
Registrant information
Name
Maryam Khoshideh
Name of organization / entity
Tehran University of Medical Sciences, Arash Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 0909
Email address
khooshide@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Science
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Nifedipin and magnesium sulfate effect on inhibition of preterm labor
Public title
Effect of Nifedipin and magnesium sulfate on preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Singleton pregnancy; gestational age32-34 weeks; 30 second contractions and one contraction in 10 minutes at least ; intact amniotic sack; cervical dilatation 2 cm
Exclusion criteria: Underlying medical condition; severe preeclampsia; intrauterine infections; congenital anomalies
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random allocation was performed by a methodologist using Stata V.13 in 6-piece blocks. The code of medicines were placed in similar packets and the sequence of medicines and list of random allocation of patients were not disclosed to dispensing practitioners. To conceal the random allocation process, a random 10-digit code corresponding to the identification number of the patient was written on each packet. These packets were given to the dispensing nurse, who was unaware of the contents of each packet. When the gynecologis declared the eligibility of patients, the nurse gave packets to hers according to the identification numbering. The person who assessment outcomes is unaware of the process of random allocation and type of treatment.Because of difference type of drugs administration,participants will not unaware of kind of treatments so this study is single blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Science
Street address
Khlije Fars boulevard, Zahedan
City
Zahedan
Postal code
Approval date
2007-01-02, 1385/10/12
Ethics committee reference number
85-2592
Health conditions studied
1
Description of health condition studied
Preterm labor
ICD-10 code
060.0
ICD-10 code description
Preterm delivery without delivery
Primary outcomes
1
Description
Contraction
Timepoint
Every 4 hours to first 24 hours and then every 12 hours for 2 times
Method of measurement
Medical examination
Secondary outcomes
1
Description
blood pressure
Timepoint
every 15 minutes up to 2 hour and every hour up to 24 hours
Method of measurement
Manometer
2
Description
Shortness of breath
Timepoint
every 15 minutes up to 2 hour and every hour up to 24 hours
Method of measurement
asking the patient
3
Description
Tachycardia
Timepoint
every 15 minutes up to 2 hour and every hour up to 24 hours
Method of measurement
Measuring the pulse
Intervention groups
1
Description
Interventionl group: 10 mg oral Nifedipin is administered and if contractions continue for 15 minutes, the second dose is administered and continued every quarter of an hour for 1 hour. Then a 10 mg Nifedipin capsule per 6 hours is administered and continued to 24 hours.
Category
Treatment - Drugs
2
Description
Control group: 4 grams magnesium sulfate in 200 cc Ringer serum is infused during 20 minutes and then 2 grams magnesium sulfate is infused per hour and continued up to 24 hours or 2 hours after contraction.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abitleb Hospital
Full name of responsible person
Dr. Maryam Khooshide
Street address
Salamat Street
City
Zahedan
2
Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Maryam Khoshideh
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Science
Full name of responsible person
Dr. Mohammad Hashemi
Street address
Khlije Fars boulevard
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Maryam Khooshide
Position
gynecologist
Other areas of specialty/work
Street address
Arash Women Hospital, Rashid Street, Resalat Highway,Tehranpars
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
khooshide@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Maryam Khooshide
Position
gynecologist
Other areas of specialty/work
Street address
Arash Women Hospital, Rashid Avenue, Resalat Highway,Tehranparse