Protocol summary

Summary
The goal of this article is the study of the effects of sysembrium seeds consumption on spontaneous beginning of parturition in the primigravida in Rafsanjan 20006. In this study 170 persons were selected randomly from the referrers to the health care centers of the city with inclusion criteria (the Iranian primgravida; hadn’t used any scientific or herbal methods in order fasilating their parturition; candid for vaginal delivery and didn’t have any recognized or predictable problems for cesarean as they entered to the study and 28 packets which contain 2mesghal (equal to about 9 gram) of sysembrium – seeds were given to the intervention group from 37th week, whereas the non-intervention group hadn’t received it. The data gathering tool was questionnaires which one part of them had been completed in 7 health care centers of Rafsanjan and the trained midwifes had completed the rest of them in the maternity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101065556N1
Registration date: 2012-05-28, 1391/03/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-05-28, 1391/03/08
Registrant information
Name
Neda Mohammadinia
Name of organization / entity
Nursing college of iranshahr
Country
Iran (Islamic Republic of)
Phone
+98 54 7222 5595
Email address
mohammadinia@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences and Health Services
Expected recruitment start date
2007-01-20, 1385/10/30
Expected recruitment end date
2008-04-20, 1387/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying effects of the sysembrium seeds consumption on spontaneous labor in primigravid
Public title
Studying effects of the sysembrium seeds consumption on spontaneous labor in nuliparus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: the Iranian primgravida; hadn’t used any scientific or herbal methods in order fasilating their parturition; referr to one of the seven health care centers in the city for their gestational cares; candid for vaginal delivery and didn’t have any recognized or predictable problems for cesarean as they entered to the study; Their parturition had planed to perform in Nicknafas educational health care center of Rafsanjan Exclusion criteria: unIranian national; multigravid; used any scientific or herbal methods in order fasilating their parturition; referr to one of personal health care centers in the city for their gestational cares; candid for cesarean delivery and have recognized or predictable problems for cesarean as they entered to the study; unknown or not planned where their parturition.
Age
From 18 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 170
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan University of Medical Science and Health Services Ethics Comitte
Street address
111111; aliebnabitaleb square; rafsanjanUniversity of Medical Science; kerman
City
rafsanjan
Postal code
111111
Approval date
2006-08-20, 1385/05/29
Ethics committee reference number
3243/9/31

Health conditions studied

1

Description of health condition studied
pregnancy,childbirth
ICD-10 code
O60
ICD-10 code description
Preterm labour and delivery

Primary outcomes

1

Description
Spontaneus labour
Timepoint
Refered to hospital(labour time) and post intervention
Method of measurement
Questionaire

2

Description
Cervix maturation
Timepoint
Post intervention
Method of measurement
Cervix examination & questionaire

Secondary outcomes

1

Description
Newborn apgar score
Timepoint
First and fifth minute of post partum
Method of measurement
Standard scale apgar

Intervention groups

1

Description
non intervention group at 37th week of gestational (term time) consume daily a one glass of warm water and one spoon of sugar
Category
Placebo

2

Description
According to the resources 28 packets which contain 10 gram of sysembrium – seeds were given to the intervention group at 37th week of gestational (term time) along with the questionnaires. They had trained to consume daily a pocket of London rocket – seeds with one glass of warm water and one spoon of sugar and mark the table which is devised at the back of the questionnaires of the intervention group for the assurance of their consumption
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Nicknafs Maternal Hospital (Rafsanjan)
Full name of responsible person
Marzieh loripoor
Street address
111; Nicknafs Maternal Hospital; Shohada Street; Rafsanjan; Kerman
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical sciences and Health Services
Full name of responsible person
Jaafarzadeh Abdollah
Street address
111; University of Medical Science; Aliebnabitaleb Square;Rafsanjan; Kerman
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical sciences and Health Services
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Rafsanjan Nursing & Midwifery College
Full name of responsible person
Jaberansari Ali
Street address
11;Nursing & Midwifery College; Modares Aven; Rafsanjan; Kerman
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan Nursing & Midwifery College
Proportion provided by this source
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
Zahedan Univercity of Medical Sciences and Health Services
Full name of responsible person
Neda Mohammadinia
Position
T eacher & Academy Member
Other areas of specialty/work
Street address
111; Nursing & Midwifery College; Baloch Bolv; Iranshahr; Sistan Balochistan Province
City
Iiranshahr
Postal code
111
Phone
+98 54 7331 0483
Fax
+98 54 7331 0485
Email
mohammadinia@zaums.ac.ir; mohammadinia55@yahoo.com
Web page address
www.zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences and Health Services
Full name of responsible person
Neda Mohammadi Nia
Position
Master Science Nursing & Faculty
Other areas of specialty/work
Street address
Nursing & Midwifery College; Baloch Bolv; Iranshahr, Sistan Balochistan Province
City
Iranshahr
Postal code
111
Phone
+98 54 7331 0483
Fax
+98 54 7331 0485
Email
mohammadinia@zaums.ac.ir;mohammadinia55@yahoo.com
Web page address
www.rums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Scinces and Health Services
Full name of responsible person
Neda Mohammadi Nia
Position
Teacher & Faculty
Other areas of specialty/work
Street address
111; Nursing & Midwifery College; Baloch Bolv;Iranshahr; Sistan Balochistan Province
City
Iranshahr
Postal code
111
Phone
+98 54 7331 0483
Fax
+98 54 7331 0485
Email
mohammadinia@zaums.ac.irmohammadinia55@yahoo.com
Web page address
www.zaums.ac.ir

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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