The purpose of this randomized, single–blind clinical trial was to determine and compare uteroplacental circulation and obstetrics complications in pregnant PCOS women treated with Aspirin or Metformine with control group. 105 patients were enrolled in the study after obtaining written consent and assessing uterine artery PI with doppler ultrasonography at 12th week of gestational age. The patients were assigned into three groups of 35 patients each using block randomization method to receive either Aspirin, 80 mg tablets daily Metformine, 2000 mg tablets, daily, or no intervention till the end of pregnancy. Uterine artery PI was assessed for the patients at 20th gestational week and they were followed until the end of pregnancy. Uterine artery PI, obstetrics complications such as preeclampcia, IUGR, GDM, and preterm Labor were assessed and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812123485N1
Registration date:2010-04-06, 1389/01/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-06, 1389/01/17
Registrant information
Name
Forozan Milani
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1722 9328
Email address
milani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical science
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2009-09-21, 1388/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of metformine on the uteroplacental circulation in comparison with Aspirin in pregnant women with poly cystic ovary syndrome
Public title
The effect of metformine on the uteroplacental circulation in comparison with Aspirin in pregnant women with poly cystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: PCOS diagnosis before pregnancy was based on the presence of poly cystic ovaries verified by ultrasonography and oligomenorea (length of menstrual cycle more than 35 days or hirsutism, gestational age 5-12 weeks, single live fetus, pregnant women between 18-40years and
Exclusion criteria: Inability to follow up
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
105
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
Tehran University of Medical Sciences
Street address
Shariati Hospital, North Karegar Ave.
City
Tehran
Postal code
Approval date
2009-02-16, 1387/11/28
Ethics committee reference number
E-0072
Health conditions studied
1
Description of health condition studied
Uteroplcental circulation and complication of pregnancy
ICD-10 code
E28.2
ICD-10 code description
Pcos (poly cystic ovary syndrome)
Primary outcomes
1
Description
Uteroplcental circulation
Timepoint
At 12th week of gestational age (before intervention) and 8 weeks after intervention
Method of measurement
Uterine Artery Doppler Ultrasound
Secondary outcomes
1
Description
Preterm labour
Timepoint
After Delivery
Method of measurement
Termination of pregnancy before 37th gestational age
2
Description
Preeclampsia
Timepoint
Monthly routine control of pregnancy
Method of measurement
Evaluation of BP and urine protein exam
3
Description
Rate of Gestational Diabet
Timepoint
at 24-28 weeks of pregnancy or 12-16 weeks after intervention
Method of measurement
GTT
4
Description
Rate of IUGR
Timepoint
After Delivery
Method of measurement
weight below the 10th percentile for gestational age after Delivery
Intervention groups
1
Description
Metformine, oral Tab, 2000 mg Daily until delivery
Category
Treatment - Drugs
2
Description
Aspirin, oral Tab, 80 mg daily until delivery
Category
Treatment - Drugs
3
Description
no treatment until delivery
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ashraf Jamal
Street address
Shariati Hospital, North Kargar Ave., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Guilan University of Medical Sciences
Full name of responsible person
Dr. Forozan Milani
Position
Assistant Professor, Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproduction Healt research center – Alzahrahospital –Namjoo Street
City
Rasht
Postal code
Phone
+98 13 1722 9328
Fax
Email
milani@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Ashraf Jamal
Position
Professor, Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Shariati Hospital, North Karegar Ave.,
City
Tehran
Postal code
Phone
+98 21 8822 0041
Fax
Email
jamalsh@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Forozan Milani
Position
Assistant Professor, Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproduction Healt research center, Alzahra hospital, Namjoo Street
City
Rasht
Postal code
Phone
Fax
Email
milani@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)