This is a randomized clinical trial. The aim of this study was to compare the effect of nifedipine and magnesium sulfate for treatment of preterm labor. Participants were 100 singleton pregnant women between 24 to 37 weeks of gestation with signs of preterm labor referred to Alzahra hospital in 2003. Exclusion criteria was maternal or fetal indications of pregnancy termination. After obtaining Consent letter, Women were divided in two groups: nifedipine and magnesium sulfate. Vital signs, vaginal bleeding, rupture of membranes, fetal heart rate, and uterine contractions were monitored.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012062310089N1
Registration date:2013-06-07, 1392/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-07, 1392/03/17
Registrant information
Name
Roya Faraji Darkhaneh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
h_fertility@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Guilan University of Medical Sciences
Expected recruitment start date
2003-03-03, 1381/12/12
Expected recruitment end date
2004-06-16, 1383/03/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of magnesium sulfate and nifedipine in the successful treatment of preterm labor
Public title
Magnesium sulfate and nifedipine on treatment of preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Singleton pregnancy, 24 to 37 weeks of gestation, signs of preterm labor.
Exclusion criteria : premature rupture of membrane, cervical dilatation > 4 cm, gestational age < 24 or >37 weeks, chorioamnionitis, vaginal bleeding, multiple pregnancy, previous cesarean section, previous uterus surgery, maternal or fetal indications for termination of pregnancy such as preeclampsia, fetal distress, fetal growth abnormalities and decreased blood pressure.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is random
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee Vice Chancellor for Research of Guilan University of Medical Sciences
Street address
Vice Chancellor for Research, Guilan University of Medical Sciences, Namjo Street
City
Rasht
Postal code
Approval date
2003-03-03, 1381/12/12
Ethics committee reference number
336
Health conditions studied
1
Description of health condition studied
Preterm labor and delivery
ICD-10 code
O60.2
ICD-10 code description
Preterm spontaneous labor with term delivery
Primary outcomes
1
Description
Delaying delivery up to 48 hours
Timepoint
Every 15 minutes until stopping of uterine contractions
Method of measurement
Abdominal palpation of uterus
Secondary outcomes
1
Description
Cervical dilatation
Timepoint
Every 2 hours until stopping of uterine contractions
Method of measurement
Vaginal examination
2
Description
Uterine contractions
Timepoint
Every 15 minutes until stopping of uterine contractions
Method of measurement
Abdominal palpation of uterus
3
Description
Cervical effacement
Timepoint
Every 2 hours until stopping of uterine contractions
Method of measurement
Vaginal examination
4
Description
Fetal complications
Timepoint
During drug administration
Method of measurement
Physician assessment
5
Description
Maternal complications
Timepoint
During drug administration
Method of measurement
Physician assessment
Intervention groups
1
Description
Intravenous loading dose infusion was 4gr magnesium sulfate (20%) during 30 minutes, followed by a maintenance dose of 2 gr/hr until stopping or reducing uterine contractions.
(magnesium sulfate heptahydrate 20% produced by Samen pharmaceutical company, Iran.)
Category
Treatment - Drugs
2
Description
We have used one capsule nifedipine (10 mg sublingual from Dana pharmaceutical company, Iran and its Generic name was Nifi-Gel). If uterine contractions persisted, we would use another capsule every 15 minutes; until a maximum dose of 40mg for one hour. Depending on tocolytic effects of nifedipine that we have used during one hour, we used a minimal dose of 60 mg every day. After 3 days, the dose would be decreased gradually and patient will receive 20 mg/day nifedipine up to 36 weeks of gestation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital, Guilan University of Medical sciences
Full name of responsible person
Dr.Roya Faraji Darkhaneh
Street address
Namjo street, Alzahra Hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasol Sobhani
Street address
Vice Chancellor for Research, Guilan University of Medical Sciences, Namjo street
City
Rasht
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, Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Dr.Roya Faraji Darkhaneh
Position
Associated Professor Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Namjo street, Alzahra Hospital, Reproductive Health Research Center
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
royafaraji1371@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr.Roya Faraji Darkhaneh
Position
Associated Professor of Obstetrics group, Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Namjo street, Alzahra Hospital, Reproductive Health Research Center
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
royafaraji1371@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
B.S.Midwifery
Other areas of specialty/work
Street address
Reproductive Health Research Center, Alzahra Hospital, Namjo Street
City
Rasht
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)