In this study we want to suppress preterm labor and prevent mortality and morbidity of fetus and neonate .Mothers will check with include and exclude criteria: more than 6 contractions per hour resulting in a demonstrated cervical change or presumed prior cervical change (transvaginal cervical length < 2.5 cm, >50% cervical effacement, or cervical dilation ≥2 cm) ;Gestational ages are between 26-34 ; Bloody show ; Nully fetus pregnant ; Intact membranes ; BP>90 mmhg in Nifedipine group. Exclude criteria: Oligohydramnios and polyhydramnios ;Nonreactive nonstress test results ;Positive contraction stress test results ; Absent or reversed diastolic flow upon Doppler examination of umbilical blood flow ; Repetitive severe variable decelerations ;Significant vaginal bleeding consistent with abruption and placenta previa ; PPROM ;Multi fetus pregnancy ;BP<90 mmhg in Nifedipine group ; Intrauterine infection ; Pyelonefrites ;Preeclampse and GTM and anomalies. Our community will include pregnant women(26-34w) with preterm singes refers to Talegane and Azahra hospital .Sample size will be 80.Half of them will get Nifedipine and 40 mothers will get Magnesium Sulfate.These women are blocked into two groups by randomization.Efficiency and side effect of two drugs are compared .This study will continue approximately one year.The women of A group will be given Magnesium sulfate and group B will be given Nifedipine . These data will be evaluated by check list and partugram.Primary outcome will be Effacement and Dilatation that will be evaluated by vaginal examination. Length and duration of contractions will be evaluated by Abdominal tough of uterus Every 10 minute.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201308878N1
Registration date:2012-05-05, 1391/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-05, 1391/02/16
Registrant information
Name
Fereshteh Fartash
Name of organization / entity
Nursing and midwifery of tabriz medical university
Country
Iran (Islamic Republic of)
Phone
+98 41 1666 1428
Email address
fereshtefartash@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Science
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Magnesium Sulfate In Adverse With Nifedipine In Suppression Preterm labor In Pregnant With Preterm Labor
Public title
Magnesium Sulfate In Adverse With Nifedipine In suppression preterm labor In Pregnant With Preterm Labor
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria include more than 6 contractions per hour resulting in a demonstrated cervical change or presumed prior cervical change (transvaginal cervical length < 2.5 cm, >50% cervical effacement, or cervical dilation ≥2 cm) ;Gestational ages are between 26-34 ; Bloody show ; Nully fetus pregnant ; Intact membranes ; BP>90 mmhg in Nifedipine group
exclude criteria
Oligohydramnios and polyhydramnios ;Nonreactive nonstress test results ;Positive contraction stress test results ; Absent or reversed diastolic flow upon Doppler examination of umbilical blood flow ; Repetitive severe variable decelerations ;Significant vaginal bleeding consistent with abruption and placenta previa ; PPROM ;Multi fetus pregnancy ;BP<90 mmhg in Nifedipine group ; Intrauterine infection ; Pyelonefrites ;Preeclampse and GTM and anomalies
Age
From 14 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Science Of Tabriz University
Street address
Tabriz, Golgasht St.
City
Tabriz
Postal code
5138856913
Approval date
2011-11-21, 1390/08/30
Ethics committee reference number
9053
Health conditions studied
1
Description of health condition studied
Preterm labor
ICD-10 code
O60.0
ICD-10 code description
Preterm labour without delivery
Primary outcomes
1
Description
Effecement
Timepoint
In addmission
Method of measurement
Vaginal examination
2
Description
Dillatation
Timepoint
In admmision
Method of measurement
Vaginal examination
3
Description
Length and diuration of contractions
Timepoint
Every 10 minute
Method of measurement
Abdominal tough of uterus
Secondary outcomes
1
Description
Feeling of fetal movment by mother
Timepoint
In an hour
Method of measurement
Abdominal touching
2
Description
Unreliable paterns of fetal heart rate
Timepoint
In 20 minnutes
Method of measurement
Record by monitoring devices
3
Description
Newborn Apgar
Timepoint
In first and fifth min.
Method of measurement
Apgars score
4
Description
ABG of umblical cord blood
Timepoint
After birth
Method of measurement
ABG devices
5
Description
Meconium
Timepoint
After birth
Method of measurement
Finding meconium on neuborn skin or amniotic fluid or amblical cord
Intervention groups
1
Description
First group (A) will be giving 4 gram Magnesium Sulfate as a loading dose then countining 2 gram every hour until 48 hours(positive Patella reflex ,at least 12 times respiratory rates,urine output at least 30mm)at the same time this group will be giving Placebo tablet instead of Nifedipine
Category
Treatment - Drugs
2
Description
The other group will be giving Nifedipine tablet(20mg) after half an hour will be given other 20 mg of Nifedipine tablet,if contractions persist ,giving 20 mg Nifedipin will be countining every 3-8 hours until contractions will subside.at the same time serum Ringer with microset will be conduct as Plasebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Azahra hospital
Full name of responsible person
Fereshteh Fartash
Street address
Bageshomal square
City
Tabriz
2
Recruitment center
Name of recruitment center
Talegane hospital
Full name of responsible person
Fereshteh Fartash
Street address
Railway square
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Fahimeh Sehhatie shafaee
Street address
Nurcing And Midwifery University, Sought Shariaty Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?