Determining the effect of oral Dydrogesterone on preventing preterm labor for the mothers who have experienced the treated preterm labor.
Design
Clinical trial includes an intervention, a controlled and a randomized group with parallel groups.
Settings and conduct
Sampling takes place in Amir-AlMoemenin hospital.
Participants/Inclusion and exclusion criteria
The criteria of entering the study includes gestational age from 24 to 34 weeks; exclusion criteria of entering the study is premature rupture of membranes (PROM). The population of the study are pregnant women with preterm labor pain diagnosis.
Intervention groups
Intervention group will be treated with Dydrogesterone capsule (10 milligrams, twice a day). The control group will receive placebo.
Main outcome variables
checking uterine contractions and gestational age during labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190107042266N1
Registration date:2019-03-04, 1397/12/13
Registration timing:prospective
Last update:2019-03-04, 1397/12/13
Update count:0
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
Samaneh Lavvaf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
sama_lavvaf@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-20, 1397/12/29
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Checking the effect of oral Dydrogesterone (Duphaston) on preventing preterm labor: A Randomized Clinical Trial
Public title
Checking the effect of oral Dydrogesterone (Duphaston) on preventing preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
From the age of 18 to 45
Gestational age of 24 to 34 weeks (calculation based on first trimester sonography)
Not having PLP 48 hours after treatment
Single pregnancy
Not of smoking
Exclusion criteria:
Placenta Previa
Premature rupture of membranes
Chorioamnionitis
Severe preeclampsia
The use of progesterone before the study
Contraindication of progesterone
Contraindication of Tocolytic
Dilatation more than 4 centimeters
Fetal anomalies
Dissatisfaction of the patient to continue participating in the study
Pregnancy scar
Cervical cerclage
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Using randomized blocks due to the kind of treatment for pregnant women with the criterion of entering the study is divided into two groups: controlled and intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be unaware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2017-10-03, 1396/07/11
Ethics committee reference number
IR.SEMUMS.REC.1397.199
Health conditions studied
1
Description of health condition studied
Preterm labor
ICD-10 code
O60
ICD-10 code description
Preterm labor
Primary outcomes
1
Description
Preterm labor before the 37th week of pregnancy
Timepoint
From the beginning of the intervention (from the beginning of preterm labor up to the gestational age of 24 to 34 weeks) until the occurrence of the preterm labor (gestational age of 36 weeks and 6 days)
Method of measurement
Visiting the patient every other two weeks for the relapse of preterm labor pain, regular use of drugs, drug based side effects like nausea, dizziness and exhaustion
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dydrogesterone capsule with the dose of 10 milligrams, 2 tablets per day is prescribed after lunch and dinner and until the gestational age of 36 weeks and 6 days or it continues until the occurrence of the labor.
Category
Treatment - Drugs
2
Description
Control group: placebo with a very similar shape and size with Dydrogesterone capsule is prescribed twice a day after lunch and dinner and continues until the gestational age of 36 weeks and 6 days or until the occurrence of the labor.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-AlMoemenin hospital
Full name of responsible person
Dr Mojgan Rahmanian
Street address
Amir-AlMomenin hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
sem.ums.res@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Mojgan Rahmanian
Street address
Hospital Amir-AlMomenin, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
sem.ums.res@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
Dr Mojgan Rahmanian
Position
Semnan
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hospital Amir-AlMomenin, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
Email
sem.ums.res@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Mojgan Rahmanian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hospital Amir-AlMomenin, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
sem.ums.res@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Mojgan Rahmanian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hospital Amir-AlMomenin, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
sem.ums.res@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
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