The Comparison between the effect of Dyrogesterone and Cyclogest intake on pregnancy in case of threatened abortion
Design
Randomized, parallels clinical trial.
Settings and conduct
Participant 160 pregnant women with threatened abortion between 6 to 13 weeks of pregnancy referred to Kowsar Hospital who are willing to participate in the study were selected and put randomly in one of the groups A and B (Each group, 80 patients). For group A, Cyclogest vaginal suppository 400 mg daily and for group B, Didrogesterone tablet 20 mg daily up to the end of 16 week of pregnancy.Patients are evaluated up to 28 weeks monthly and until 36 weeks every two weeks and then weekly until delivery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age 6 to 13 weeks; Observation of fetal heart rate; vaginal bleeding; uterine closure; uterine or fetal anomalies.
Exit criteria: unwillingness of the patient; lack of fetal heart rate; severe liver problems; epilepsy; diabetes; hypertension.
Intervention groups
Intervention group1: Cyclogest vaginal suppository made by Abourihan Company, is given 400 milligrams per day from the initial of the study up to the end of 16 weeks of pregnancy.
Intervention group2: Dydrogestrone tablet made by Abourihan Company, is given 20 milligrams per day from the initial of the study up to the end of 16 weeks of pregnancy.
Main outcome variables
Preterm labor؛ Preeclampsia؛ Gestational diabetes؛ Low birth weight؛ Abortion less than 20 weeks.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120104008611N8
Registration date:2018-09-22, 1397/06/31
Registration timing:retrospective
Last update:2018-09-22, 1397/06/31
Update count:0
Registration date
2018-09-22, 1397/06/31
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
2017-05-22, 1396/03/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-07-23, 1396/05/01
Trial completion date
2018-09-21, 1397/06/30
Scientific title
The comparison between the effect of Dydrogesterone and Cyclogest intake on consequences of pregnancy in threatend abortion.
Public title
The effect of Dydrogesterone and Cyclogest on threatend abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 6 to 13 weeks
Observation of fetal heart rate
Vaginal bleeding
Uterine anomalies
Fetal anomalies
Exclusion criteria:
Patient unwillingness
Breast carcinoma
Lack of fetal heart rate
Severe liver problems
Genital carcinoma
Thromboembolic disorders
Epilepsy
Diabetes
Hypertension
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Actual sample size reached:
160
Randomization (investigator's opinion)
Not 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
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
2018-04-30, 1397/02/10
Ethics committee reference number
IR.QUMS.REC.1397.018
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
Threatened abortion
Timepoint
Before intervention and 2 weeks after the completion of the intervention
Method of measurement
Weekly visit
Secondary 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
Mercury Barometer
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
Intervention groups
1
Description
Intervention group1: Progesterone vaginal suppository made by Abourihan Company, 400 milligrams only once per day since the initial of the study up to 16 weeks of pregnancy
Category
Treatment - Drugs
2
Description
Intervention group2: Didrogesterone tablet made by Abourihan Company, 10mg twice a day (10 mg every 12 hours ) since the initial of the study up to 16 weeks of pregnancy
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 nushin kashanipoor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3333 3006
Email
Sayekam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
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 Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Email
pakniat110@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
Information is the most commonly used questionnaire, which is a statistical analysis
When the data will become available and for how long
After completing the data analysis
To whom data/document is available
All the readers of the article
Under which criteria data/document could be used
For scientific purposes, it is important to note the source
From where data/document is obtainable
Library of Qazvin University of Medical Sciences
What processes are involved for a request to access data/document