Protocol summary

Summary
The purpose of this study was to evaluate of the effect of boiled Anethum Graveolens seeds on duration and intensity of labor pain. Inclusion criteria were the first or second parity; having term pregnancy; cephalic presentation in fetus; fetus weight between 2500-4000 gram; no chronic disease in mother; no contraindication of vaginal delivery and intact of membranes. Exclusion criteria were vaginal bleeding and cesarean. Present study was single- blind randomized clinical trial that 103 participants with above characterizes were divided to intervention and control groups. Both groups were entered to study in cervical dilatation of 3 to 5 cm. Control group received routine labor cares. In intervention group, two tablespoon of Anethum Graveolens seeds in 100 cc water boiled for 10 minutes. Then, this of solution filtered and orally used by intervention group. In both groups, fetal heart rate was evaluated regularly every fifteen minutes in the first stage. Pain intensity and maternal vital sign were recorded every hour. Pelvic exam was done by the researcher based on labor characterize in each participants.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107207065N1
Registration date: 2014-07-09, 1393/04/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-09, 1393/04/18
Registrant information
Name
Seyedeh Fatemeh Hekmatzadeh
Name of organization / entity
Yasuj University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 74 1333 2276
Email address
hekmatzadeh.f@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of boiled Anethum Graveolens seeds on duration and intensity of labor pain
Public title
Effect of boiled Anethum Graveolens seeds on labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria; first or second parity; term pregnancy; cephalic presentation in fetus; fetus weight between 2500-4000 gram; no chronic disease in mother; no contraindication of vaginal delivery and intact of membranes Exclusion criteria: vaginal bleeding and cesarean
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: 103
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yasuj University of Medical Sciences
Street address
Next to Emam Sajad Hospital, Shahid Doctor Jalil street
City
Yasuj
Postal code
Approval date
2011-11-21, 1390/08/30
Ethics committee reference number
7/30/8/90

Health conditions studied

1

Description of health condition studied
Effect of boiled Anethum Graveolens seeds on duration and intensity of labor pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Duration of stages of delivery
Timepoint
One hour after invention until delivery every hour
Method of measurement
Questionnarie

Secondary outcomes

empty

Intervention groups

1

Description
In intervention group, two tablespoon of Anethum Graveolens seeds in 100 cc water boiled for 10 minutes. Then, this solution filtered and orally used by intervention group in start of active phase and 4-3 cervical dilation.
Category
Treatment - Drugs

2

Description
Control group received routine labor cares.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yasuj University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Hekmatzadeh
Street address
Next to Emam Sajad Hospital, Shahid Doctor Jalil street
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasuj University Of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Hekmatzadeh
Street address
Next to Emam Sajad Hospital, Shahid Doctor Jalil street
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj 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
Yasuj Univercity of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Hekmatzadeh
Position
Master of Science
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Yasuj
City
Yasuj
Postal code
Iran
Phone
+98 74 1223 5140
Fax
Email
sf.hekmatzadeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Hekmatzadeh
Position
Master of Science
Other areas of specialty/work
Street address
Next to Emam Sajad Hospital, Shahid Doctor Jalil street
City
Yasuj
Postal code
Iran
Phone
+98 74 1223 4115
Fax
Email
sf.hekmatzadegh@yahoo.com; hekmatzadeh.f@yums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Hekmatzadeh
Position
Master of Science
Other areas of specialty/work
Street address
Next to Emam Sajad Hospital, Shahid Doctor Jalil street
City
Yasuj
Postal code
Phone
+98 74 1223 4115
Fax
Email
sf.hekmatzadeh@yahoo.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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