Evaluation of progesterone administration effects on uterine vascular flow in pregnant women with intrauterine growth restriction fetus and preterm labor
To evaluate the effects of progestrone administration on uterine vascular blood flow in pregnant women with confirmed intrauterine growth restriction or preterm fetus, 50 pregnant women with diagnosed intrauterine growth restriction and another 50 ones with preterm initiation of labor are enrolled and those with Concomitant administration of progesterone and tocolytics or receiving progesterone in previous pregnancy are excluded. Between 24 to 48 hours after administration of tocolytics, progestrone is administered vaginally everyday. Doppler Sonography parameters of maternal uterine arteries and fetal cerebral vascular perfusion are assessed at the time of admission and 24 hours and 2 week after completing the progestrone courses and compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203289338N1
Registration date:2012-06-14, 1391/03/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-14, 1391/03/25
Registrant information
Name
Mahnaz Jahani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2382
Email address
m-jahani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of progesterone administration effects on uterine vascular flow in pregnant women with intrauterine growth restriction fetus and preterm labor
Public title
Effects of progesterone on uterine vascular flow in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women between 24 and 37 weeks of pregnancy; diagnosis of Intrauterin growth restriction or preterm labor; receiving progesterone between 24 to 48 hours after administration of tocolytics
Exclusion Criteria: Concomitant administration of progesterone and tocolytics; administration of progesterone in previous pregnancy; labor within upcoming 2 weeks; multiple gestations
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
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
Research Deputy, Faculty of Medicine, Poursina Street, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2012-04-28, 1391/02/09
Ethics committee reference number
2688/130/د/90
Health conditions studied
1
Description of health condition studied
Preterm labor and IUGR Fetus
ICD-10 code
P05.9
ICD-10 code description
Slow fetal growth, unspecified
Primary outcomes
1
Description
S/D Umbilical Artery
Timepoint
1st and 14th days
Method of measurement
Color Doppler Sonography
2
Description
PI in middle cerebral artery
Timepoint
1st and 14th days
Method of measurement
Color Doppler Sonography
3
Description
RI in Uterine Artery
Timepoint
1st and 14th days
Method of measurement
Color Doppler Sonography
4
Description
PI in middle cerebral artery
Timepoint
1st and 14th days
Method of measurement
Color Doppler Sonography
5
Description
PSV in MCA
Timepoint
1st and 14th days
Method of measurement
Color Doppler Sonography
Secondary outcomes
empty
Intervention groups
1
Description
In preterm labor group, 40 mg vaginal progesterone is administered daily within 2 weeks and Doppler sonography parameters were assessed before and after administration
Category
Treatment - Drugs
2
Description
In IUGR group, 40 mg vaginal progesterone is administered daily within 2 weeks and Doppler sonography parameters were assessed before and after administration
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valie Asr Hospital
Full name of responsible person
Dr Mahnaz Jahani
Street address
Keshavarz Bv, Imam Khomeini Complex, Valie Asr Hospital, Second Floor, Obstetrics and Gynecology Ward
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhondzadeh
Street address
Medical School Research Affairs, Poorsina Street, Keshavarz Blv
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
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Jahani
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Vali- e - Asr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blv
City
Tehran
Postal code
Phone
+98 21 6119 2382
Fax
Email
m-jahani@razi.tums.ac.ir dr.jahani33@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Jahani
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Vali- e - Asr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blv
City
Tehran
Postal code
Phone
+98 21 6119 2382
Fax
Email
m-jahani@razi.tums.ac.ir dr.jahani33@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Jahani
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Vali- e - Asr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blv
City
Tehran
Postal code
Phone
+98 21 6119 2382
Fax
Email
m-jahani@razi.tums.ac.ir dr.jahani33@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)