Effect of intravenous hydration on amniotic fluid index in women with preterm premature ruptur of membran reffering to Alzahra teaching hospital-tabriz-2010-11
Aim of this Randomized controlled trial is to examine the effect of intravenous hydration on amniotic fluid index in the pregnant women with preterm premature rupture of membrane. Our target population is pregnant women(28-34week) with complaint of leakage and rupture of membrane that reffer to clinic of hospital. JAVA software was used to determine sample size. 12 patients were randomized to the hydration group and 12 to the no hydration group. inclusion criteria: pregnant women with rupture of membrane with low fluid index below and equal the 5; single pregnancy;cephalic presantation;with no heart and lung and renal disorder;inactive labor;Reative NST; no fetus complication; duration of rupture lower than 48 h; no clinical corioamnionit.
Patients in the hydration group will be given a 1 L IV fluid bolus of isotonic serum over a period of 30 minutes. One and 48 hours after the completion of the bolus, the AFI measurement will repeat. In the no hydration group, the repeat AFI measurement will perform 90 minutes and 48 hour after the initial examination.primary outcomes are increasing the amniotic fluid index and longer time interval from the fluid bolus to delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106066709N1
Registration date:2011-08-21, 1390/05/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-21, 1390/05/30
Registrant information
Name
Mahnaz Shahnazi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mshahnazi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chencellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2011-06-14, 1390/03/24
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous hydration on amniotic fluid index in women with preterm premature ruptur of membran reffering to Alzahra teaching hospital-tabriz-2010-11
Public title
Effect of hydration on AFI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with gestational age (28-34W); rupture of membrane with low fluid index below and equal the 5; single pregnancy;cephalic presantation; with no heart and lung and renal disorder,hypertantion and hemorrhage;inactive labor,Reative NST ; there is not complication of fetus and placenta and uterus (IUGR. myoma);duration of rupture lower than 48 h; no clinical corioamnionit. Exclusion criteria: withdrew from continuing the research
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
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
Research Deputy, Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
51665118
Approval date
2011-06-02, 1390/03/12
Ethics committee reference number
909
Health conditions studied
1
Description of health condition studied
Preterm Premature Rupture Of Membrane
ICD-10 code
042
ICD-10 code description
Premature Rupture Of Membranes
Primary outcomes
1
Description
Aminiotic Fluid Index
Timepoint
Basement, 90 min,48 h
Method of measurement
Sonography
Secondary outcomes
1
Description
Time to delivery
Timepoint
From basement measure to delivery
Method of measurement
Clock
Intervention groups
1
Description
In interference group will be given a 1 L IV fluid bolus of isotonic serum over a period of 30 minutes.
Category
Treatment - Drugs
2
Description
any intervention will not be done In the control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Teaching Hospital
Full name of responsible person
Hajizadeh- Khadijeh,student of MSC in Midwifery
Street address
Baghshomal square
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chencellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Research deputy, Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chencellor for Research, Tabriz 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
Tabriz Univercity of Medical Sciences-Faculty of Nursing and Midwifery Tabriz
Full name of responsible person
Hajizadeh- Khadijeh
Position
Student of MSC in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
hajizade@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Shanazi- Mahnaz
Position
MSC in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
mshahnazi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)