The comparison between the effect of Dydrogesterone and micronized progesterone intake on consequences of pregnancy in threatend abortion.
Design
Two parallel groups randomized trial, not blinded, single center
Settings and conduct
200 pregnant women threatened with abortion from kowsar hospital which were satisfied to participate in the study were selected and randomly allocated in one of the groups A and B. For the A group micronized progesterone was prescribed and for the group B Didrogesterone tablet was prescribed.
Participants/Inclusion and exclusion criteria
Gestational age 6 to 13 weeks; Observation of fetal heart rate;Vaginal bleeding;
Absence of uterine anomalies; Absence fetal anomalies
Intervention groups
Intervention group 1: Didrogesterone tablet made by Abourihan Company, 10 mg twice a day (10 mg every 12 hours ) since the initial of the study up until one week after bleeding and intervention group 2: Progesterone capsule made by Tansim Company,100 mg twice a day since the initial of the study up until one week after bleeding
Main outcome variables
Preeclampsia; Gestational Diabetes; Preterm labor; Low birth weight; Abortion under 20 weeks of pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120104008611N10
Registration date:2020-01-31, 1398/11/11
Registration timing:registered_while_recruiting
Last update:2020-01-31, 1398/11/11
Update count:0
Registration date
2020-01-31, 1398/11/11
Registrant information
Name
Hamideh Pakniat
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 282242452
Email address
hpakniat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between the effect of Dydrogesterone and micronized progesterone intake on consequences of pregnancy in threatend abortion.
Public title
The effect of Dydrogesterone and micronized progesterone on threatend abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 6 to 13 weeks
Observation of fetal heart rate
Vaginal bleeding
Absence of uterine anomalies
Absence fetal anomalies
Exclusion criteria:
Breast carcinoma
Severe liver problems
Genital carcinoma
Thromboembolic disorders
Epilepsy
Diabetes
Hypertension
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
Participants were randomly assigned to one of two study groups using the random number table and received group-based intervention. The medications include Dydrogesterone and Lutogel capsules (micronized progesterone), which are encoded in separate envelopes and are used in addition to patient education on the envelope and delivered to participants.
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
Ethics committee of Qazvin University of Medical Sciences
Street address
Vice-Chancellor for Research of Qazvin University of Medical Sciences, Valiasr street, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Approval date
2019-11-07, 1398/08/16
Ethics committee reference number
IR.QUMS.REC.1398.183
Health conditions studied
1
Description of health condition studied
Threatened abortion
ICD-10 code
O20.0
ICD-10 code description
Threatened abortion
Primary outcomes
1
Description
Preeclampsia
Timepoint
Up to 28 weeks monthly and until 36 weeks every two weeks and thereafter weekly until delivery
Method of measurement
Sphygmometer
2
Description
Gestational Diabetes
Timepoint
Up to 28 weeks monthly and until 36 weeks every two weeks and then weekly until delivery
Method of measurement
Glucose tolerance test
3
Description
Preterm labor
Timepoint
Up to 28 weeks monthly and until 36 weeks every two weeks and then weekly until delivery
Method of measurement
Tocometry of uterus and delivery before 37 weeks of pregnancy
4
Description
Low birth weight
Timepoint
Weight immediately after birth
Method of measurement
Pediatric scales
5
Description
Abortion under 20 weeks of pregnancy
Timepoint
Every week from the start of the intervention up to 20 weeks of pregnancy
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Didrogesterone tablet made by Abourihan Company, 10 mg twice a day (10 mg every 12 hours ) since the initial of the study up until one week after bleeding
Category
Treatment - Drugs
2
Description
Intervention group 2: Progesterone capsule made by Tansim Company,100 mg twice a day since the initial of the study up until one week after bleeding
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Dr Hamide Pakniat
Street address
Taleghani Blvd, Valiasr
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Fax
+98 28 3323 6374
Email
pakniat110@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Vice-Chancellor for Research of Qazvin University of Medical Sciences, Valiasr street, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3333 6001
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr Hamide pakniat
Position
Assistant Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Email
pakniat110@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Hamide Pakniat
Position
Assistant Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Blvd, Valiasr
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Email
pakniat110@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Hamide Pakniat
Position
Assistant Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Blvd, Valiasr
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Email
pakniat110@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because sharing participants' personal information is not a goal of our study.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After obtaining informed consent, patient information was recorded in the questionnaire and after receiving the drugs, the results were again recorded in the questionnaire for statistical analysis. This sharing will occur after the end of the study.
When the data will become available and for how long
Starting 1 years after publication.
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
Statistical analysis will then be used by the statistical consultant and the documentation results will be identified.
From where data/document is obtainable
Applicants should contact Dr Hamideh Paknat, the project manager, to obtain the required documentation or data. Ways of communicating are by email, by phone, or by visiting the Kowsar Qazvin Training Center.
Postal address: Kowsar Hospital, Taleghani Street, Qazvin
Email: pakniat110@yahoo.com
Phone no: 028- 33236378
What processes are involved for a request to access data/document
The applicant must first notify the project manager by email.Then, as soon as possible, in less than a week, the Designer will provide the requested information at the discretion.