Comparison the effect of dill seeds and oxytocin infusion on the duration of labor and labor pain in primiparous women and pregnant women who experience second delivery : a clinical trial
The aim of this study is to compare the effects of infusion of oxytocin and oral brewed dill seeds on labor duration and intensity of labor pain. In this study, 100 primiparous women and pregnant women who experience second delivery and will attend the hospital due to labor pain will be entered. The randomization technique is as the following: cards in which the letters A and B are written on will be placed in a container and the samples are asked to pick one. If the card is labelled A, the participant will enter in the intervention group (dill seed), and if the card is labeled B, the participant will enter in the control group (oxytocin). The person who will conduct the test is unaware of the grouping. Participants in both groups are at the beginning of the active phase of labor and do not have regular pain. In the intervention group, 10 g dill seeds will add to 100 cc boiled water and will be stewed for 5 minutes and will be consumed orally by the women at the beginning of the active phase of the labor. In the control group, 10 units of oxytocin in 1000 ml of Ringer will be infused. The infusion will be start by 5 drops per minute and will increase until the beginning of regular uterine contractions and then the number of droplets will get fixed. Inclusion criteria: being at 37-40 weeks of gestational age; 5-3 cm cervical dilatation; cephalic presentation of fetus; absence of chronic diseases; intact membranes. The exclusion criteria: any contraindication for vaginal delivery; hemorrhage; indication for cesarean section. Fetal heart rate will be checked every quarter of an hour in all participants. 20-minute non-stress test will be done on patients during labor. Vaginal examination will be performed every hour. Pain intensity will be measured each hour using the pain scale. The main outcomes of the study: labor pain intensity and length of three delivery stages
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607177065N2
Registration date:2017-03-20, 1395/12/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-20, 1395/12/30
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
Vice chancellor for research, Yasuj University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of dill seeds and oxytocin infusion on the duration of labor and labor pain in primiparous women and pregnant women who experience second delivery : a clinical trial
Public title
Comparison the effects of oxytocin and dill seed on delivery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: being at 37-40 weeks of gestational age; 5-3 cm cervical dilatation; cephalic presentation of fetus; absence of chronic diseases; intact membranes. The exclusion criteria: any contraindication for vaginal delivery; hemorrhage; indication for cesarean section.
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:
100
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
Ethics committee of Yasuj University of Medical Sciences
Street address
Beside Imam Sajad Hospital, Shahid Doctor Jalil Street
City
Yasuj
Postal code
Approval date
2013-02-16, 1391/11/28
Ethics committee reference number
93.12.25.5
Health conditions studied
1
Description of health condition studied
delivery
ICD-10 code
080-084
ICD-10 code description
delivery
Primary outcomes
1
Description
Duration of first stage of labor
Timepoint
During labor
Method of measurement
Questionnaire
2
Description
Duration of second stage of labor
Timepoint
During labor
Method of measurement
Questionnaire
3
Description
Duration of third stage of labor
Timepoint
During labor
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Labor pain
Timepoint
During labor
Method of measurement
Visual Analog Scale (VAS)
Intervention groups
1
Description
Intervention group: 10 g dill seeds will add to 100 cc boiled water and will be stewed for 5 minutes and will be consumed orally by the women at the beginning of the active phase of the labor.
Category
Treatment - Drugs
2
Description
Control group: 10 units of oxytocin in 1000 ml of Ringer will be infused. The infusion will be start by 5 drops per minute and will increase until the beginning of regular uterine contractions and then the number of droplets will get fixed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Maternity ward of Imam Sajjad Haspital of Yasuj
Full name of responsible person
Seyedeh Fatemeh Hekmatzadeh
Street address
Yasuj Univesity of Medical Sciences, Nursing and Midwifery School.
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Yasuj University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Hekmatzadeh
Street address
Nursing And Midwifery School of Yasuj University of Medical Sciences ,
City
Yasuj
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 of 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
Nursing and Midwifery School, Yasuj University Medical of Scinces
Full name of responsible person
Seyedeh Fatemah Hekmatzadeh
Position
Master
Other areas of specialty/work
Street address
Beside Imam Sajad Hospital, Shahid Doctor Jalil Street
City
Yasuj
Postal code
Phone
+98 74 3323 4115
Fax
Email
sf.hekmatzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery, Yasuj University Medical of Scinces
Full name of responsible person
Seyedeh Fatemeh Hekmatzadeh
Position
Master
Other areas of specialty/work
Street address
Beside Imam Sajjad Hospital, Shahid Doctor Jalil Street
City
Yasuj
Postal code
Phone
+98 74 3323 4115
Fax
Email
sf.hekmatzadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery, Yasuj University Medical of Scinces
Full name of responsible person
Seyedeh Fatemeh Hekmatzadeh
Position
Master
Other areas of specialty/work
Street address
Beside Imam Sajad Hospital, Shahid Doctor Jalil Street
City
Yasuj
Postal code
Phone
+98 74 3323 4115
Fax
Email
sf.hekmatzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)