Comparing the efficacy of vaginal progesterone (cyclogest) versus injection of 17a hydroxyprogesterone caproate ( proluton) in preventing of preterm brth less than 34 weeks gestation in pregnant women with threatend abortion in Arash Hospita
(1)Objectives: compare the effect of intravaginal cyclogest and Proloton treatment on preterm labor in women with threatened abortion refferring to Arash hospital.
(2) Design:A randomized clinical trial phase 2, single blind
(3) Setting and conduct: Women referring to Arash hospital emergency with the complain of threatened abortion in 20-12 weeks, randomly are divided into two groups of cyclogest or Proloton recievers.
(4) Participants including major eligibility criteria: 182 patients will be enrolled in this study by convenience sampling. Exclusion criteria incloud: known systemic disease, fever, and not see the gestational sac yolk sac in weeks 5.5 to 6 weeks of pregnancy or fetus at 6 to 6.5 weeks of gestation or cardiovascular activity at 7 week, short cervical length at 16-24 weeks of gestation or twin pregnancy.
(5) Intervention: Group 1 will receive Proloton wth the dose of 250 mg/IM/ weekly and the second group will receive vaginal Cyclogest with the dose of 400 mg/daily.
(6) main outcome(measures variables) : two interventional groups will assess in terms of stopping bleeding and uterine gramphay, abortion and pregnancy outcomes up to 34th week of pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014123120504N1
Registration date:2015-02-07, 1393/11/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-07, 1393/11/18
Registrant information
Name
Arezoo Esmailzadeh
Name of organization / entity
Tehran University of Medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
dr.a.esmailzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran Uviversity of Medical Science
Expected recruitment start date
2014-11-28, 1393/09/07
Expected recruitment end date
2015-04-30, 1394/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of vaginal progesterone (cyclogest) versus injection of 17a hydroxyprogesterone caproate ( proluton) in preventing of preterm brth less than 34 weeks gestation in pregnant women with threatend abortion in Arash Hospita
Public title
effect of progestron in preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
women referring to Arash hospital emergency with the complain of threatened abortion in 20-12 weeks (vaginal bleeding and uterine cramps) incloud the study.
Exclusion criteria are: known systemic disease; fever; not see the gestational sac yolk sac in 5.5 to 6 weeks of pregnancy; fetus at 6 to 6.5 weeks of gestation; cardiovascular activity at 7 week; short cervical length at 16-24 weeks of gestation; twin pregnancy
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
182
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran Uviversity of Medical Science
Street address
Tehran University of Medical Sciences, Keshavarz blvd., Ghods st.
City
Tehran
Postal code
Approval date
2014-06-10, 1393/03/20
Ethics committee reference number
93/د/130/556
Health conditions studied
1
Description of health condition studied
pre term labor
ICD-10 code
O60
ICD-10 code description
Onset (spontaneous) of labour before 37 completed weeks of gestation
Primary outcomes
1
Description
assessment of pre term labor
Timepoint
after 34 weeks
Method of measurement
obsaervational
Secondary outcomes
1
Description
abortion
Timepoint
after 8 weeks of treatment
Method of measurement
observational
2
Description
lenghth of cervix
Timepoint
16- 24 weeks
Method of measurement
sonography
Intervention groups
1
Description
The first group of women who complained of threats to abortion 20-12 weeks (vaginal bleeding and uterine cramps) go to the Arash hospital and how cyclogest intravaginal progesterone 400 mg daily
Category
Treatment - Drugs
2
Description
The second group of women who complained of threats to abortion 20-12 weeks (vaginal bleeding and uterine cramps) go to the Arash hospital and how to administer intramuscular injections of 250 mg Proloton is once a week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Arezoo Esmailzadeh
Street address
Arash hospital, Tehranpars, Resalat highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoudi Yonesian
Street address
Tehran University of Medical Sciences, Keshavarz blvd., Ghods st.
City
Tehran
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, 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
Dr Abootaleb Beigi
Position
Specialist of Obstetrics and gynaecology ,prenatology floship
Other areas of specialty/work
Street address
Arash hospital, Tehranpars, Resalat highway
City
Tehran
Postal code
Phone
+98 21 7788 3283
Fax
Email
beigi_a@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
Dr Abootaleb Beigi
Position
Specialist of Obstetrics and gynaecology ,prenatology floship
Other areas of specialty/work
Street address
Arash hospital, Tehranpars, Resalat highway
City
Tehran
Postal code
Phone
+98 21 7788 3283
Fax
Email
beigi_a@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
Dr Arezoo Esmailzadeh
Position
MD
Other areas of specialty/work
Street address
Arash hospital, Tehranpars, Resalat highway
City
Tehran
Postal code
Phone
+98 21 7788 3283
Fax
Email
dr.a.esmailzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)