Oligohydramnios is the volume of amniotic fluid that is lower than the expectance for pregnancy age and if it will be higher than normal, it will cause to abnormality of fetal, compression of cord and finally death. The purpose of this study is to determine the effect of oral and intravenous fluid therapy by hypotonic liquid for pregnant women with partial oligohyramnios and study changes of amniotic fluid volume in these groups before and after treatment.
This clinical study was done in 60 pregnant women between 35 to 38 weeks of pregnancy that had amniotic fluid index between 5 to 10 c.m with normal amniotic bag and fetus without any abnormality in sonography. They were divided in 3 groups. First group did not receive any treatment and were as control group, the second group treated by oral hydration with 2L\2 h and finally the third group treated by intravenous hypotonic liquid (ringer) with 2L\2 h. Before and 1 hour after treatment sonography was done and AFI was calculated.
General information
Acronym
.
IRCT registration information
IRCT registration number:IRCT201102203820N2
Registration date:2011-04-08, 1390/01/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-08, 1390/01/19
Registrant information
Name
Zinatalsadat Bouzari
Name of organization / entity
Babol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 4651
Email address
z_b412003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and technology, Babol University of Medical Sciences
Expected recruitment start date
2008-05-21, 1387/03/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral and intravenous maternal hydration in third trimester of pregnancy on increasing the amniotic fluid index
Public title
The effect of liquid treatment on increasing the amniotic fluid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Amniotic fluid index 5-10 cm, Amniotic membrane intact, age of Pregnancy 35-36 week, Normal fetus. Exclusion criteria: Toxemia of pregnancy, patients with previous gestational diabetes, cardiovascular disease, hyperthyroidism, fetus with congenital defect.
Age
From 16 years old to 45 years old
Gender
Female
Phase
3
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
Vice Chancellor for Research and technology, Babol University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Postal code
Approval date
2008-07-21, 1387/04/31
Ethics committee reference number
842
Health conditions studied
1
Description of health condition studied
Oligohydramnios
ICD-10 code
O41.0
ICD-10 code description
Oligohydramnios
Primary outcomes
1
Description
Amniotic fluid index
Timepoint
Before treatment and 1 h after treatment
Method of measurement
sonography
Secondary outcomes
empty
Intervention groups
1
Description
First group: is control group and did not receive any treatment
Category
N/A
2
Description
Second group: was treated by oral hydration with 2L\2 h (water)
Category
Other
3
Description
Third group: was treated by intravenous hypotonic liquid (ringer) with 21\2 h
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Yahiianejad Hospital
Full name of responsible person
Dr. Maryam Javadian Kotenae
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Grant name
.
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and technology, Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Zinatossadat Bouzari
Position
Assistant professor
Other areas of specialty/work
Street address
Rohani Hospital
City
Babol
Postal code
Phone
+98 11 1222 8444
Fax
Email
z_b412003@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Maryam Javadian Kotenae
Position
Assistant professor
Other areas of specialty/work
Street address
Rohani Hospital
City
Babol
Postal code
Phone
+98 11 1329 0139
Fax
Email
z_b412003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible for Public Affairs Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Research Center, Noshirvani street
City
Babol
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)