The purpose of the present study is to evaluate the effect of copper supplementation during pregnancy on the preterm premature rupture of membranes (PPROM), premature rupture of membranes (PROM) and pregnancy outcomes. Study will be conducted as a triple blind randomized clinical trial. The participants (200) will randomly be divided into the 2 groups. In one group copper in a dose of 1000 milligram and in the other group, placebo will be prescribed orally from 16th week of pregnancy. Then the pregnancy outcome including PROM, PPROM, birth weight, placental abruption, placenta previa, hemorrhage during pregnancy, anemia, infection, preterm labor, and preeclampsia will be compared between the 2 groups. Drug adverse effects will be evaluated too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008112624N7
Registration date:2010-11-16, 1389/08/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-11-16, 1389/08/25
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology, Iran University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of copper supplement during pregnancy on premature and pregnancy outcome
Public title
Copper prescription in pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: nuliparity, age between 18-35, second trimester of pregnancy, and having written consent. Exclusion criteria: multiple pregnancy, history of any systemic disorders or drug use except iron supplement, known copper sensitivity, polyhydramnios, fetal death, fetal anomalies, smoking, alcohol consumption and drug abuse.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Scieces
Street address
Hemmat Highway, Chamran Cross.
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
896.1
Health conditions studied
1
Description of health condition studied
pregnancy outcome
ICD-10 code
O00-O99
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
preterm premature rupture of membranes and premature rupture of membranes
Timepoint
9 months
Method of measurement
questionnaire
Secondary outcomes
1
Description
Pregnancy outcome
Timepoint
9 months
Method of measurement
questionnaire
2
Description
birth weight
Timepoint
Delivery
Method of measurement
questionnaire
3
Description
placental abruption, placenta previa, hemorrhage during pregnancy
Timepoint
9 months
Method of measurement
questionnaire
4
Description
anemia
Timepoint
9 months
Method of measurement
Hemoglobin
5
Description
preterm labor
Timepoint
9 months
Method of measurement
questionnaire
6
Description
preeclampsia
Timepoint
9 months
Method of measurement
questionnaire
7
Description
drug adverse effects
Timepoint
9 months
Method of measurement
questionnaire
8
Description
infection
Timepoint
9 months
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Copper tablets, 1000 mg per day from 16th week of pregnancy up to delivery
Category
Prevention
2
Description
Control group: placebo tablets, from 16th week of pregnancy up to delivery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran prenatal care centers
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Iran University of Medical Sciences
Full name of responsible person
Dr. Motavallian
Street address
Hemmat Highway, Chamran Cross.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
MD, Associate professor
Other areas of specialty/work
Street address
Iran University of Medical Scieces
City
Tehran
Postal code
16117
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
MD, Associate professor
Other areas of specialty/work
Street address
Iran University of Medical Scieces
City
Tehran
Postal code
16117
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
MD,Associate professor
Other areas of specialty/work
Street address
Iran University of Medical Scieces
City
Tehran
Postal code
16117
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)