Studying the effects of ascorbic acid on serum level of unconjugated estriol
and its relationship in prevention of preterm premature rupture of membrane
The purpose of this study is to check the effect of ascorbic acid on serum level of unconjugated estriol and its relationship on preterm premature rupture of membranes.
In this double-blind clinical trial, 60 pregnant women with gestational age 18 weeks who were at the risk of PPROM were companies. Of those pregnant women with a history of surgery on the uterus and a history of cesarean section and were inoculated with a history of pregnancy, were excluded. Patients were divided in to intervention and control groups randomly. 250 mg of vitamin C supplement was prescribed to the intervention group and placebo prepared with apparent drug profile as the same dose and frequency of intervention' s drug (twice daily) was prescribed to control group. Treatment duration was to 28 weeks of gestational age. At 28 weeks gestation serum level of unconjugated estriol was measured by ELIZA method. And results in both groups were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012083580N3
Registration date:2011-04-05, 1390/01/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-05, 1390/01/16
Registrant information
Name
Mehrangiz Zamani
Name of organization / entity
Hamadan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6293
Email address
m.zamani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan University of Medical Sciences and Health Services
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-21, 1389/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effects of ascorbic acid on serum level of unconjugated estriol
and its relationship in prevention of preterm premature rupture of membrane
Public title
Effect of ascorbic acid in prevention of preterm premature rupture of membrane
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with gestational age 18 weeks who are suspicious of PPROM.
Exclusion criteria:
1- Lack of follow up patients
2- Lack of cooperation of patients in taking the drug and placebo in time
3- History of surgery on uterus
4- History of cesarean section
5- Experience of artificial insemination pregnancy
6- Smoking
7- Short cervix
Age
From 20 years old to 40 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences and Health Services
Street address
Hamedan university of medical science, in front of Mardom Park, Pazhohesh crossroads, Hamedan
City
Hamedan
Postal code
65177_89975
Approval date
2010-10-06, 1389/07/14
Ethics committee reference number
17-5-3-1
Health conditions studied
1
Description of health condition studied
PPROM
ICD-10 code
o42.9
ICD-10 code description
Premature rupture of membranes, unspecified
Primary outcomes
1
Description
Unconjugated estriol
Timepoint
Is measured once.
Method of measurement
special laboratory kit
2
Description
Frequency of preterm premature rupture of membranes
Timepoint
10 weeks after taking drug and plecebo
Method of measurement
questionnaire
Secondary outcomes
1
Description
Complications after delivery
Timepoint
be assessed after delivery
Method of measurement
questionnaire
Intervention groups
1
Description
250 mg vitamin C supplement was given to intervention group twice a day. ( 500 mg daily ) Patients were taking this supplement from 18 to 28 weeks of pregnancy.
Category
Prevention
2
Description
Placebo which was produced with apparent drug profile of intervention group with the same frequency ( twice a day ) was prescribed to control group. Patients were taking placebo from 18 to 28 weeks of pregnancy.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Obstetrics and Gynecology Hospital
Full name of responsible person
Street address
City
Hamedan
2
Recruitment center
Name of recruitment center
Sheikhorayis clinic
Full name of responsible person
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamedan University of Medical Sciences and Health Services
Full name of responsible person
Ms. Zhila Ahmadkhani
Street address
Hamedan Medical university, in front of Mardom Park, Pazhohesh crossroads, Hamedan
City
Hamedan
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, Hamedan University of Medical Sciences and Health Services
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
Hamedan university of Medical Science and Health Service
Full name of responsible person
Dr. Lavasani
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemieh hospital, Kermanshah st.
City
Hamedan
Postal code
6517789975
Phone
+98 912 289 4910
Fax
Email
navaz_lavasani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan university of medical science
Full name of responsible person
Dr. Mehrangiz Zamani
Position
Assistant Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Fatemieh Obstetrics and Gynecology Hospital, Kermanshah st, Shariyati square, Hamedan
City
Hamedan
Postal code
65177_89975
Phone
+98 81 1835 3090
Fax
+98 81 1828 3939
Email
m.zamani@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan university of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Zamani
Position
Assistant Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
City
Hamedan
Postal code
65177_89975
Phone
+98 81 1835 3090
Fax
+98 81 1828 3939
Email
m.zamani@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)