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Comparing the effectiveness of Nifedipine and magnesium sulfate in treating preterm labor.

Protocol summary

Summary
Aim of this study was comparing the effectiveness of nifedipine and magnesium -sulfate in treating preterm labor. during the year 2011, a group of 110 cases of preterm labor at their 27th-36th of Gestation were entered and blindly divided into two groups of 55 patients. While, one group was treated with oral Nifedipine, the other was administered intravenous Mg-sulfate. inclusion criteria were 4 contractions per 20 min, while dilatation of cervices were > 1cm & effacement > 85 % and Exclusion criteria were rupture of membranes, vaginal bleeding, fetal distress, dilatation of cervix >3cm, and a blood pressure below 90/50 mm Hg. cases were treated either by 10 mg of nifedipine orally repeated up to 4 dozes per 20/min which was continued by 20mg/4-8hr and then every 12 hours or by 4gr/20min of Mg-Sulfate intravenously which was continued by 1g/hr up to 24hr, in case of no contraindications treatments were continued till 48hr or 12hr after clinical responses for nifedepine and 24hr for mg-sulfate groups. 48 hours of treatments were watched and patients were controlled for contractions. if no contractions were observed it was considered as clinical response, meanwhile headache, hypotension, dyspnea and tachycardia considered as maternal complications and neonatal outcome was described by 1st min Apgar score.

General information

Acronym
preterm / threatened preterm labor and Nifedipine
IRCT registration information
IRCT registration number: IRCT2013052113421N1
Registration date: 2015-02-20, 1393/12/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-20, 1393/12/01
Registrant information
Name
Fariba Nanbakhsh
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1346 7167
Email address
f.nanbakhsh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
research deputy of urmia university of medical sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Nifedipine and magnesium sulfate in treating preterm labor.
Public title
Comparing the effectiveness of Nifedipine and magnesium sulfate in treating preterm labor.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Patients in 27th-36th of Gestation; 4 contractions per 20 min; dilatation of cervices > 1cm; effacement > 85 % ; intact membranes; have gestational age determined by LMP or ultrasonogeraphical study; Not to be included if : any indication for termination of pregnancy; any previous medication as tocolysis ; Placental abruption; infection; contra indictions of ca-blocker usage; primarily, a blood pressure below 90/50; Exclusion : were rupture of membranes; vaginal bleeding; fetal distress; dilatation of cervix >3cm; blood pressure below 90/50 mm Hg.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Reproductive health research center
Street address
urmia, kashani street, Reproductive health research center, health center No6, third flour, No 42
City
urmia
Postal code
57156-65895
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
56

Health conditions studied

1

Description of health condition studied
Preterm labour
ICD-10 code
O60.0
ICD-10 code description
Preterm labour without delivery

Primary outcomes

1

Description
hampering contractions of labor.
Timepoint
48 hours from beginning of treatments.
Method of measurement
observation by gynecologist.

Secondary outcomes

1

Description
maternal complications : headache, hypotension, dyspnea and tachycardia.
Timepoint
48 hours of medication.
Method of measurement
observation and physical examination by gynecologist

2

Description
Neonatal outcome : 1st min Apgar score.
Timepoint
Just exact after labor.
Method of measurement
Physical examination & observation by gynecologist.

Intervention groups

1

Description
In Nifedipine group : Patients were treated by 10 mg of nifedipine orally repeated up to 4 dozes per 20/min which was continued by 20mg/4-8hr and then every 12 hours till 48hr or 12hr after clinical responses.
Category
Treatment - Drugs

2

Description
In Mg-sulfate group : Patients were treated by 4gr/20min of Mg-Sulfate intravenously which continued by 1g/hr up to 24hr, in case of no contraindications treatment continued till 24hr or for 24hr after clinical responses.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Hospital of Urumia, genycology department
Full name of responsible person
Dr. Fariba nanbakhsh
Street address
Kosar Hospital of Urumia, Kashani Street,
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
urmia university of medical sciences, deputy of research and technology.
Full name of responsible person
Dr. Firouz Ghaderi Pakdel,
Street address
Urumia University of Medical science, Resalat Ave, Urgans Street.
City
Urumia
Grant name
00
Grant code / Reference number
00
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
urmia university of medical sciences, deputy of research and technology.
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
Urumia University of Medical Science
Full name of responsible person
Dr. Fariba nanbakhsh
Position
Associate Professor / Gynecologist, Fellowship of Infertility.
Other areas of specialty/work
Street address
Kashani Street,Urmia Reproductive Health Research Center, Urmia, Iran
City
Urumia
Postal code
Phone
+98 44 3344 5138
Fax
+98 44 3344 5138
Email
faribanan@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urumia University of Medical Science
Full name of responsible person
Dr. Fariba nanbakhsh
Position
Associate Professor ; Gynecologist, Fellowship of Infertility.
Other areas of specialty/work
Street address
Room n.42, Urmia reproductive Health research cente, Kashani Street.
City
Urmia
Postal code
Phone
+98 44 1344 5138
Fax
Email
f.nanbakhsh@umsu.ac.ir faribanan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urumia University of Medical Science
Full name of responsible person
Dr. Fariba nanbakhsh
Position
Associate Professor / Gynecologist, Fellowship of Infertility.
Other areas of specialty/work
Street address
Room n.42, Urmia reproductive Health research cente, Kashani Street.
City
Urumia
Postal code
Phone
+98 44 3344 5138
Fax
Email
‏00984433445138 
009141415815 
04433445138 
faribanan@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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