Preterm delivery is defined a birth occurring before 37 weeks of gestation or before 259 days from the last menstrual period and its incidence has increased during the last decade in most countries. Several drugs have been suggested for treatment of preterm labor but suitable and safe drug is not still available.The aim of this study is comparison of Nifedipin versus Magnesium Sulfate in treatment of preterm labor.120 pregnant women in 24-34 gestational weeks who are admitted in Rohani Hospital of Babol because of preterm labor are randomly assigned to receive Magnesium Sulfate (n=60)or Nifedipine (n=60).Before enrolling in this study the informed consent from women is obtained. The first step of management is bed rest and hydration by 500cc infusion of ringer solution and 50 mg Pethedine IM for two groups. If contractions are continued all patients will receive Betamethasone 12mg IM twice, 24 hours apart and randomly receive either oral Nifedipine or intravenous Magnesium Sulfate. Demographic and obstetrics characteristics, maternal and fetus adverse effects, clinical assessment, time to failure of the treatment are record by questionnaire . Fetal distress and induced delivery are excluded from study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301281760N20
Registration date:2013-05-11, 1392/02/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-11, 1392/02/21
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2012-12-10, 1391/09/20
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprasion of nifedipin versus magnesium salfate in Treatment of preterm labor
Public title
Comprasion of nifedipin versus magnesium salfate in Treatment of preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 24w-34w gestational age with a diagnosis of preterm labor; at least four contractions[During the "30 in 20 minutes with increasing cervical dilatation and effacement] (2cm dilatation or effacement of 80%).
Exclusion criteria: multiple pregnancies; corioamnionitis؛ preeclampsia, abruption previa, liver disease, heart and blood pressure, maternal vaginal bleeding; IUGR; IUFD; Fetal distress, fetal major anomaly; PPROM; (PR> 100, BP <90/50) ³ 5cm dilatation.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
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
The ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Postal code
Approval date
2012-12-09, 1391/09/19
Ethics committee reference number
1671
Health conditions studied
1
Description of health condition studied
preterm labor
ICD-10 code
O60
ICD-10 code description
Preterm labour and delivery
Primary outcomes
1
Description
Premature birth control
Timepoint
Before 37 weeks of gestation
Method of measurement
Clinical
Secondary outcomes
1
Description
Adverse effects of maternal magnesium sulfate versus nifedipine
Timepoint
Three days a week during the first 48 hours of onset of pain
Method of measurement
clinical
2
Description
Magnesium sulfate versus nifedipine complication rate of fetal tachycardia
Timepoint
Three days a week during the first 48 hours of onset of pain
Method of measurement
clinical
3
Description
The effect of nifedipine versus magnesium sulfate to stop the contractions of
Timepoint
Three days a week during the first 48 hours of onset of pain
Method of measurement
Clinical
Intervention groups
1
Description
Intervention :
Patients in Nifedipine group will receive 10mg orally and follow every 20 minutes for total four doses and assess for blood pressure.Then received 20 mg orally every 6 hours until 24 hours and every 8 hours until next 24 hours.
Category
Treatment - Drugs
2
Description
Control:
Patients in Magnesium Sulfate group will receive 4gr bolus and follow by 2gr/h infusion. All patient assess for urinary output, DTR, respiratory rate, The drug will continue until 12 hours after stopping of contractions.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani hospital
Full name of responsible person
Mahboubeh Ramzani
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
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 and Technology, Babol University of Medical Sciences
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
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
MA/Responsible for Public Affairs of Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
ngh_pa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh Zahra Fertility & Reprodactive Health Research Center
Full name of responsible person
Dr. Nesa Asnafi
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
asnafi2001@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh Zahra Fertility & Reprodactive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
MA/Responsible for Public Affairs of Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)