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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201103025955N1 |
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Date of registration:
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2012-04-30 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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the effect of Mg sulfate and Nifedipine effect on umbilical cord blood PH
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Scientific title:
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Comparison of Mg sulfate and Nifedipine effect on umbilical cord blood PH in neonates 23-36 age of gestation |
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Date of first enrolment:
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2011-03-23 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/6431 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr .Shohreh Alimohamadi
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Address:
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Fatemieh Hospital ; Kermanshah Street ; Hamedan
65177-89971
Hamedan
Iran (Islamic Republic of) |
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Telephone:
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+98 81 1827 0713 |
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Email:
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Dr-alimohamadi@yahoo.com |
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Affiliation:
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Hamedan University Of Medical Siences |
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Name:
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Faezeh Moshayedi
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Address:
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Fatemieh Hospital; Kermanshah Street ; Hamedan
65177-89971
Hamedan
Iran (Islamic Republic of) |
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Telephone:
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+98 81 1827 7012 |
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Email:
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Dr_alimohamadi@yahoo.com ; f.moshayedi@umsha.ac.ir |
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Affiliation:
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Hamedan University Of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion 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
Exclusion criteria:
Age minimum:
no limit
Age maximum:
no limit
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cord PH in preterm neonates.
Labour and delivery complicated by biochemical evidence of fetal stress
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Labour and delivery complicated by biochemical evidence of fetal stress
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Intervention(s)
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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.
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Intervention 1: 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. Intervention 2: 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.
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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.
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Prevention
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Primary Outcome(s)
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Umbilical Cord blood Ph In preterm Neonates. Timepoint: After Delivery. Method of measurement: Ph measure with Technomedia Blood Gass Device.
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Source(s) of Monetary Support
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Vice Chncellor For Research Hamedan University Of Medical Siences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics and research committee of Hamedan University Of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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