Main outcome : comparison of Mg-sulfate and Nifedipine effect on umbilical cord blood PH in 23-36 weeks neonates
Design : Clinical trial , phase 2 or 3 clinical trial ,single centric
Participants including major eligibility criteria : All of the pregnant women 23-36 weeks age of gestation with stable vital sign , intact amniotic membrane, no fetal abnormality were entered to the study and multi gestation and rupture of membrane were exported from the study.
Sample volume : 60 pregnant women that divided to 2 groups .each group include 30 patients.
Interventions : One group was treated with Mg-sulfate and another one was treated with Nifedipine.
Time of interventions : 3o minutes after hydration and analgesic therapy.
Main outcome : umbilical cord blood PH
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103025955N1
Registration date:2012-04-30, 1391/02/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-30, 1391/02/11
Registrant information
Name
Faezeh Moshayedi
Name of organization / entity
Hamedan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 81 1825 3333
Email address
f.moshayedi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University Of Medical Sciences
Expected recruitment start date
2011-03-23, 1390/01/03
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Mg sulfate and Nifedipine effect on umbilical cord blood PH in neonates 23-36 age of gestation
Public title
the effect of Mg sulfate and Nifedipine effect on umbilical cord blood PH
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant women 23-36 week of gestation; intact amniotic membrane; No fetal abnormality in ultrasound; Single; Stable maternal vital sign.
Exclusion Criteria: Rubture of membrane; multi gestation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics and research committee of Hamedan University Of Medical Sciences
Street address
University Of Medical Sciences , Fahmideh Avenue , Hamedan
City
Hamedan
Postal code
65178/518
Approval date
2011-03-14, 1389/12/23
Ethics committee reference number
16/35/9/19/پ/د
Health conditions studied
1
Description of health condition studied
Cord PH in preterm neonates
ICD-10 code
068.3
ICD-10 code description
Labour and delivery complicated by biochemical evidence of fetal stress
Primary outcomes
1
Description
Umbilical Cord blood Ph In preterm Neonates
Timepoint
After Delivery
Method of measurement
Ph measure with Technomedia Blood Gass Device
Secondary outcomes
empty
Intervention groups
1
Description
In the second group, 30 minutes after hydration and analgesic agents , Nifedipine was initiated in this protocol : At first ,10 mg , and every 8 hours until 24 hours ; and then 20 mg every 8 hours , until the second 24 hours . And treatment was cut.
Category
Prevention
2
Description
In the first group, that accidentally were treated with Mg-sulfate, 30 minutes after hydration and analgesic agents , Mg sulfate was started in this protocol : 4 gr IV slow infusion in 10 minutes, after that 2 gr in 100 cc ringer lactete serum was continued until the uterine contractions were cut.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan Fatemieh Hospital
Full name of responsible person
Faezeh Moshayedi
Street address
Fatemieh Hospital , Kermanshah Street , Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chncellor For Research Hamedan University Of Medical Siences
Full name of responsible person
Dr. Heidar Tavilani
Street address
Vice Chancellor For Research Hamedan University Of Medical Sciences, Fahmideh Avenue , Hamedan
City
Hamedan
Grant name
123900
Grant code / Reference number
123900-1
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chncellor For Research Hamedan University Of Medical Siences