1.Determination of the effect of intravenous fluid therapy on amniotic fluid index in oligohematerialis.
2.Comparison of the mean of amniotic fluid index before and after intravenous fluid therapy in mothers with oligohydramnios.
Design
Firstly, women of the age group of 35 or more gestational age who are willing to participate in the research with a written consent and who have the characteristics of the research unit are selected and embedded in the experimental group.
Each mother in the study will receive 3000 ml of Ringer serum within 24 hours. 48 hours after administration of intravenous fluid therapy, sonography is performed to determine the amniotic fluid index for mother.
The present study does not have control group.
Settings and conduct
Firstly, oligohydramnios women with a gestational age of 35 weeks or more who were referred to Iran Hospital of Iranshahr are selected and embedded in the experimental group.In the experimental group, the study will receive 3000 milligrams of Ringer serum within 24 hours. For 48 hours after administration of intravenous fluid therapy, sonography is performed to determine the amniotic fluid index for both groups. Blinding was performed for data analyzers. .
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Single pregnancy; Intact Amniotic Sac; gestational age greater than or equal to 35 weeks; amniotic fluid index less than or equal to 5 cm.
EXclusion Criteria:
Normal Amniotic Fluid index; Polyhydramnios.
Intervention groups
In the intervention group, each mother will receive 3000 ml of Ringer serum within 24 hours. After 48 hours of intravenous fluid administration, sonography is performed to determine the amniotic fluid index.
The present study does not have control group.
Main outcome variables
Amniotic fluid index.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160418027464N3
Registration date:2019-05-14, 1398/02/24
Registration timing:retrospective
Last update:2019-05-14, 1398/02/24
Update count:1
Registration date
2019-05-14, 1398/02/24
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 37212968054
Email address
dr.azarkish@irshums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
2016-06-09, 1395/03/20
Actual recruitment end date
2018-10-22, 1397/07/30
Trial completion date
2018-10-22, 1397/07/30
Scientific title
The effect of intravenous fluid therapy on amniotic fluid index in oligohydramnios.
Public title
Effect of Intravenous hydrotherapy on "Ammonium fluid reduction"
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnancy
Intact Amniotic fluid
Gestational age greater than or equal to 35 weeks
َAmniotic fluid index less than or equal to 5 cm.
Exclusion criteria:
Normality of the amniotic fluid index.
Polyhydramnios
Twin Pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The study design was a quasi-experimental clinical trial without control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iranshahr University of Medical Sciences
Street address
Balouch street
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
99157-19444
Approval date
2015-10-25, 1394/08/03
Ethics committee reference number
IR.IRSHUMS.REC.1394.11
Health conditions studied
1
Description of health condition studied
Oligohydramnios
ICD-10 code
O41.9
ICD-10 code description
Disorder of amniotic fluid and membranes, unspecified
Primary outcomes
1
Description
Amniotic fluid index.
Timepoint
48 hours after intervention.
Method of measurement
Sonoghraphy
Secondary outcomes
1
Description
Amniotic Fluid Index.
Timepoint
48 hours after intervention.
Method of measurement
sonography.
2
Description
Apgar the first minute
Timepoint
Immediately after childbirth
Method of measurement
Newborn Clinical Examination
Intervention groups
1
Description
Intervention group: In the experimental group, the study will receive 3000 cc of Ringer serum within 24 hours and will be performed in the routine care control group for oligohematerial patients. 48 hours after administration of intravenous fluid therapy, sonography was performed to determine the amniotic fluid index for the group. It will be
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Iranshahr Hospital
Full name of responsible person
Fatemeh Azarkish
Street address
Balouch
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۷۶۱۸۸۱۵۶۷۶
Phone
+98 54 3721 3328
Email
Azarkish2005@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Tameneh Salehian
Street address
Balouch
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۷۶۱۸۸۱۵۶۷۶
Phone
+98 54 3721 0485
Email
Azarkish2005@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranshahr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Fatemeh Azarkish
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Balouch
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۷۶۱۸۸۱۵۶۷۶
Phone
+98 54 3722 7940
Email
Azarkish2005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Fatemeh Azarkish
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Balouch
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۷۶۱۸۸۱۵۶۷۶
Phone
+98 54 3722 7940
Email
Azarkish2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Fatemeh Azarkish
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Balouch Street
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۷۶۱۸۸۱۵۶۷۶
Phone
+98 54 3822 7940
Email
Azarkish2005@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD