Comparison the effectiveness of Progesterone and Duphaston as tocolytic agents vs placebo, to prevent from preterm labor and its complication.
Design
Randomized clinical trial with 2 intervention group and 1 control group / parallel groups.
Settings and conduct
Sampling will be conducted in Imam Reza, Ghaem and Om-mol-banin hospitals of Mashhad.
Participants/Inclusion and exclusion criteria
Gestational age between 24-34 weeks / Maternal age between 18-37 years old / Singleton pregnancy / Contractions occur one to eight minutes apart / Dilatation less than 3 cm. / Effacement less than 80 percent / intact amniotic membrane.
Intervention groups
The first intervention group receives Duphaston tab (10 mg/ twice per day), the second one receives Progesterone suppository (200 mg daily) and third group or control / placebo, receives none of them.
Main outcome variables
Uterine contractions and gestational age at delivery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180303038922N1
Registration date:2018-03-17, 1396/12/26
Registration timing:prospective
Last update:2018-03-17, 1396/12/26
Update count:0
Registration date
2018-03-17, 1396/12/26
Registrant information
Name
Zeynab Khademi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 0000
Email address
khademiz2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of progesterone, Duphaston, and placebo to increase gastaional age in preterm labor
Public title
Effectiveness of progesterone, Duphaston, and placebo to prevent preterm birth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 24-34 weeks
Maternal age between 18-37 years old
Singleton pregnancy
Contractions occur one to eight minutes apart.
Dilatation less than 3 cm.
Effacement less than 80 percent
intact amniotic membrane
Exclusion criteria:
Maternal or fetal conditions that necessitate urgent delivery
fetal anomalies
Evidence for tocolytic drug contraindication
Allergy to progestrone
Age
From 18 years old to 37 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table
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 Mashhad University of Medical Sciences
Street address
Qoreishi Building, Daneshgah Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2017-10-11, 1396/07/19
Ethics committee reference number
IR.MUMS.FM.REC.1396.416
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
Uterine contractions
Timepoint
every 2 weeks until 36 weeks and then weekly.
Method of measurement
Uterine contractions are measured by Cardiotachometer.
Secondary outcomes
1
Description
Gestational age at labor
Timepoint
every 2 weeks until 36 weeks and then weekly
Method of measurement
gestational age in weeks (based on first trimester ultrasound)
Intervention groups
1
Description
Intervention group: Duphaston group
Category
Treatment - Drugs
2
Description
Intervention group: progesterone group
Category
Treatment - Drugs
3
Description
Control group: No intervention
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Zeynab Khademi
Street address
Ahmad abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3801 2469
Email
Khademiz2@mums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Zeynab Khademi
Street address
Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3854 3031
Email
Khademiz2@mums.ac.ir
3
Recruitment center
Name of recruitment center
Om-mol-banin hospital
Full name of responsible person
Zeynab Khademi
Street address
Ayatollah Behjat Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3223 1061
Email
Khademiz2@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Qoreighi Building, Daneshgah Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Lotfalizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza hospital. Imam Reza square.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3854 3031
Fax
Email
LotfalizadeM@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Lotfalizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza hospital. Imam Reza square.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3854 3031
Fax
Email
LotfalizadeM@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zeynab Khademi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shariati Sq. Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Fax
Email
Khademiz2@mums.ac.ir
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
To protect the privacy of the participants in the study.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available