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Effect of different dosage of progesterone on uterine and placental vascular resistance in women at risk of preterm birth

Protocol summary

Study aim
Effect of different dosage of progesterone on uterine and placental vascular resistance in women at risk of preterm birth
Design
Clinical trials with control group, with parallel groups, Non-random, single center trial. Sample size (3 groups of 30 control and intervention).
Settings and conduct
Amir Al-Momenin Hospital, Semnan. All three groups will initially undergo color Doppler ultrasound of the uterine vessels, umbilical artery, and middle cerebral artery of the fetus. In the first group 400 mg progesterone and in the second group 200 mg progesterone is given vaginally. and the third group is studied as a control group.
Participants/Inclusion and exclusion criteria
Pregnant women at risk of preterm birth. Inclusion criteria: Singleton pregnancy; Pregnancy age 24 to 33 weeks. Exclusion criteria: A history of intrauterine insemination (IUI); In vitro fertilization (IVF) history.
Intervention groups
Intervention group 1: In this group, a 400 mg progesterone suppository will be used vaginally according to the treatment protocol. Intervention group 2: In this group, a 200 mg progesterone suppository will be used vaginally according to the treatment protocol. Control group: Only for comparison with intervention group, no treatment is performed.
Main outcome variables
Uterine artery Resistance Index; Uterine artery Pulsatility Index.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151228025732N48
Registration date: 2020-02-04, 1398/11/15
Registration timing: registered_while_recruiting

Last update: 2020-02-04, 1398/11/15
Update count: 0
Registration date
2020-02-04, 1398/11/15
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of different dosage of progesterone on uterine and placental vascular resistance in women at risk of preterm birth
Public title
Effect of progesterone on uterine and placental vascular resistance in women at risk of preterm birth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Singleton pregnancy Pregnancy age 24 to 33 weeks
Exclusion criteria:
A history of intrauterine insemination (IUI) In Vitro Fertilization history (IVF)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.SEMUMS.REC.1398.187

Health conditions studied

1

Description of health condition studied
Preterm labour
ICD-10 code
O60.0
ICD-10 code description
Preterm labor without delivery

Primary outcomes

1

Description
Uterine artery Resistance Index
Timepoint
Before and 48 hours after intervention
Method of measurement
Doppler ultrasound

2

Description
Uterine artery Pulsatility Index
Timepoint
Before and 48 hours after intervention
Method of measurement
Doppler ultrasound

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In this group, a 400 mg progesterone suppository will be used vaginally according to the treatment protocol.
Category
Treatment - Drugs

2

Description
Intervention group 2: In this group, a 200 mg progesterone suppository will be used vaginally according to the treatment protocol.
Category
Treatment - Drugs

3

Description
Control group: Only for comparison with intervention group, no treatment is performed.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Mojgan Rahmanian
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.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
Mojgan Rahmanian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hospital AmirAlMomenin, Mostafa Khomeini Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mojgan Rahmanian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hospital AmirAlMomenin, Mostafa Khomeini Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parisa Amini
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@yahoo.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
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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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