Evaluation of the effect of oral Dydrogesterone (Duphaston) in threatened abortion at first trimester referring to Mahdieh and Shohada-e-Tajrish Hospitals during the years 2016 and 2017
Design
In this clinical trial, 170 pregnant women aged 18 to 35 years of age eligible for the study are randomly assigned into two groups of oral therapy and control groups, according to the random number table.
Settings and conduct
Pregnant women aged 18 to 35 years old eligible for the study referred to Mahdieh and Shohad-e Tajrish hospitals hospitals after obtaining written consent and recording information (age, age, last menstrual period (LMP), gestational age, history of previous pregnancies, vaginal bleeding history in previous pregnancies, vaginal bleeding amount and history of abortion) are randomly divided into two groups of oral dystrogestrone (duphestone) and control, and were monitored for up to 20 weeks. The duration of vaginal bleeding is recorded before and after the study and the occurrence of abortion will record.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women aged 18 to 35 years old; singleton pregnancy; symptoms and signs of threaten abortion in the first trimester; an ultrasound report with viable fetus
Exclusion criteria: Presence of underlying conditions such as high blood pressure and diabetes; allergies to dystrogesterone components
Intervention groups
The case group: Treatment with oral dyrogesterone (Duphaston®, Solvay company, USA), 40 mg in the first dose, followed by 10 mg every eight hours until the bleeding was discontinued and the relative rest in the bed.
The control group: Only conservative treatment with relative rest in the bed
Main outcome variables
Duration of vaginal bleeding and the occurrence of abortion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120918010876N5
Registration date:2018-02-04, 1396/11/15
Registration timing:registered_while_recruiting
Last update:2018-02-04, 1396/11/15
Update count:0
Registration date
2018-02-04, 1396/11/15
Registrant information
Name
Masumeh Mirza Moradi
Name of organization / entity
Prinatalogy department of Mahdieh hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 6263
Email address
m-bakhtiyari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-21, 1396/08/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral Dydrogesterone (Duphaston) on vaginal bleeding and abortion rate in threatened abortion at first trimester
Public title
Evaluation of the effect of oral Dydrogesterone (Duphaston) in threatened abortion at first trimester
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women in the first trimester
Presence of symptoms and signs of threatened abortion
Singleton pregnancy
Having an ultrasound report with viable fetus
Exclusion criteria:
The presence of underlying illnesses such as high blood pressure, diabetes
Known allergy to dystrogesterone components
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
Use the random numbers table and randomization according to the the order of entering to the study
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 Shahid Beheshti University of Medical Sciences
Street address
Velenjak St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
IR.SBMU.MSP.REC.1396.600
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
Abortion
Timepoint
Daily check from the beginning of the study up to 20 weeks
Method of measurement
Observation and clinical symptoms
2
Description
Vaginal bleeding
Timepoint
At the beginning of the study and after starting the study until the end of the study
Method of measurement
Amount and number of sanitary pads
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment with oral dyrogesterone (Duphaston®, Solvay company, USA), 40 mg in the first dose, followed by 10 mg every eight hours until the bleeding was discontinued and the relative rest in the bed
Category
Treatment - Drugs
2
Description
Control group: Only conservative treatment with relative rest in the bed
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Dr. Masoome Mirzamoradi
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh-haspital@yahoo.com
2
Recruitment center
Name of recruitment center
Shohada-e Tajrish Hospital
Full name of responsible person
Dr. Masoome Mirzamoradi
Street address
Tajrish Sq.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ali Ziayee
Street address
Next to Taleghani Hospital, Shahid Arabi St., Yemen St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoome Mirzamoradi
Position
Perinatologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 6263
Fax
Email
drmoradi000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoome Mirzamoradi
Position
Perinatologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 6263
Fax
Email
drmoradi000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Kobra Taherian
Position
Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 6263
Email
dr.taherian.z1362@gmail.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
No need for publication
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
Undecided - It is not yet known if there will be a plan to make this available