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Clinical trial of the effects of garlic tablet in reduction of premature labor in women

Protocol summary

Summary
Objective: To assess Effect of garlic in reducing preterm labor in women Design: Randomized and placebo-controlled, double-blind, single-center. Method: Pregnant women randomly assigned to one of two groups garlic consumption and the use of progesterone suppository 400 mg or placebo and 400 mg progesterone suppository in other group. Informed consent will be taken of all participants. Inclusion criteria: Personal or family history of premature labor, abdominal surgery during pregnancy, high-risk jobs, a history of bleeding the first trimester, multiparity, uterine anomalies, uterine myoma, a history of second-trimester abortion, history cervical surgery, age less than 18 or more than 40, hemoglobin less than 10. Exclusion criteria: disease such as diabetes, hypertension, autoimmune diseases, major fetal anomaly, cerclage, drug allergies, along with placental abruption and preeclampsia Outcome: Determine of premature labor less than 37 weeks in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011824754N4
Registration date: 2017-01-20, 1395/11/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-20, 1395/11/01
Registrant information
Name
Neda Hajiha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8163 3615
Email address
nedahajiha94@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-05-14, 1395/02/25
Expected recruitment end date
2017-01-29, 1395/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effects of garlic tablet in reduction of premature labor in women
Public title
Clinical trial of the effects of garlic tablet in reduction of premature labor in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Personal or family history of premature labor, abdominal surgery during pregnancy, high-risk jobs, a history of bleeding the first trimester, multiparity, uterine anomalies, uterine myoma, a history of second-trimester abortion, history cervical surgery, age less than 18 or more than 40, hemoglobin less than 10. Exclusion criteria: disease such as diabetes, hypertension, autoimmune diseases, major fetal anomaly, cerclage, drug allergies, along with placental abruption and preeclampsia
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 580
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic comittee, Tehran University of Medical Sciences
Street address
Tehran
City
Tehran
Postal code
Approval date
2016-05-10, 1395/02/21
Ethics committee reference number
IR.TUMS.REC.1395.2581

Health conditions studied

1

Description of health condition studied
Premature Labor
ICD-10 code
060.1
ICD-10 code description
Preterm spontaneous labour with preterm delivery

Primary outcomes

1

Description
Delivery before 37 weeks of pregnancy
Timepoint
Weekly
Method of measurement
Count the number of weeks from the first day of the last menstrual period

Secondary outcomes

empty

Intervention groups

1

Description
Therapeutic intervention with drug: garlic tablets (tablets coated 600 mg garlic) with suppository 400 mg of progesterone for 16 to 22 weeks
Category
Prevention

2

Description
Therapeutic intervention with placebo: progesterone suppository 400 mg with pharmaceutical starch for 16 to 22 weeks
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Mohebe Yas Hospital
Full name of responsible person
Street address
North Villa St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Tehran University of Medical Science, Ghods street, Keshavarz Blvd., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zeina Shaker Ardakani
Position
Assistant of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Moheb Yas hospital, North Villa St,
City
Tehran
Postal code
Phone
+98 214216000
Fax
Email
zeinabshaker62@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shirin Niroomanesh
Position
Full Professor
Other areas of specialty/work
Street address
Moheb Yas hospital, North Villa St.
City
Tehran
Postal code
Phone
+98 214216000
Fax
Email
niromanesh@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zeina Shaker Ardakani
Position
Assistant of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Moheb Yas hospital, North Villa St
City
Tehran
Postal code
Phone
+98 214216000
Fax
Email
zeinabshaker62@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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