The effect of dydrogesterone in prevention of preeclampsia in high-risk pregnancy of primigravidae women that has been referred to gynecology clinic
Design
Randomized (random block method), double-blind study, placebo control, single arm trial. The sample size of this study is 168 individuals: divided into 2 groups of 84 people.
Settings and conduct
Amiralmomenin Hospital in Semnan
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women that have aged 18 to 40 years; nulliparous Women; the body mass index is equal to or greater than 30 kg / m2.
Exclusion criteria: The history of consumption of progesterone supplements in the last 6 months; contraindications for the use of progesterone; use of drugs that induce liver enzymes activation (carbamazepine, phenytoin and rifampin); diagnosis of embryonic anomalies by ultrasound; previous cases of systemic diseases, such as asthma, diabetes, liver and kidney disorders, cardiovascular disease, connective tissue diseases.
Intervention groups
Control group: placebo from the 7th week of pregnancy (it consists of sugar and starch, in terms of shape, size and color, exactly the same as Duphaston®, 3 times a day) until 14-16 weeks of pregnancy.
Intervention group: Daily 30 mg dydrogesterone from the 7th week of pregnancy (10 mg Duphaston® tablet manufactured by ABBOTT Heal THCARE, Netherlands, (Importer of Behestan Pharmaceutical Company), 3 times a day) until 14-16th week of pregnancy.
Main outcome variables
Vaginal bleeding.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N30
Registration date:2018-02-18, 1396/11/29
Registration timing:registered_while_recruiting
Last update:2018-02-18, 1396/11/29
Update count:0
Registration date
2018-02-18, 1396/11/29
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-12, 1396/09/21
Expected recruitment end date
2018-12-11, 1397/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dydrogesterone in prevention of preeclampsia in high-risk pregnancy of primigravidae women that has been referred to gynecology clinic
Public title
The effect of dydrogesterone in prevention of preeclampsia in high-risk pregnancy of primigravidae women that has been referred to gynecology clinic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women that have aged 18 to 40 years
Nulliparous Women
The body mass index is equal to or greater than 30 kg / m2
Exclusion criteria:
The history of consumption of progesterone supplements in the last 6 months
Contraindications for the use of progesterone
Use of drugs that induce liver enzymes activation (carbamazepine, phenytoin and rifampin)
Diagnosis of embryonic anomalies by ultrasound
Previous cases of systemic diseases, such as asthma, diabetes, liver and kidney disorders, cardiovascular disease, connective tissue diseases.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
168
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 2).
Using Excel software to generate random number tables.
Blinding (investigator's opinion)
Double blinded
Blinding description
To a group of A drug packs and to the second group of B drug packs will be given; thus, the patients and the investigator (the presenter) will be unaware of the treatment group and placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2018-02-06, 1396/11/17
Ethics committee reference number
IR.SEMUMS.REC.1396.161
Health conditions studied
1
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O00-O99
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Vaginal bleeding
Timepoint
During pregnancy and after childbirth
Method of measurement
Examination
Secondary outcomes
empty
Intervention groups
1
Description
Control group: placebo from the 7th week of pregnancy (it consists of sugar and starch, in terms of shape, size and color, exactly the same as Duphaston®, 3 times a day) until 14-16 weeks of pregnancy.
Category
Diagnosis
2
Description
Intervention group: Daily 30 mg dydrogesterone from the 7th week of pregnancy (10 mg Duphaston® tablet manufactured by ABBOTT Heal THCARE, Netherlands, (Importer of Behestan Pharmaceutical Company), 3 times a day) until 14-16th week of pregnancy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Sanam Moradan
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Scienes, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sanam Moradan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sanam Moradan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hadiseh Jahanpour
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 33451336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
Only available to scholars working in academic institutions.
Under which criteria data/document could be used
In case of relevant studies.
From where data/document is obtainable
Sanam Moradan.
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd, Semnan.
00989127312407
What processes are involved for a request to access data/document