Comparison the effect of oral consumption of Date syrup with Honey Saffron syrup on progress of delivery in primiparous women admitted to the delivery ward of Besat Hospital in sanandaj, 2019
Design
This study is a randomized clinical trial.Number of sample will be180 and includes one control group and two intervention groups.
Settings and conduct
The study will be performd in the delivery department. professot of emirares is not aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to cooperate, cervical dilatation 4 cm when entering the study, age between18 to 35, single pregnancy, gestational age between 37 to 42 weeks, no indication of cesarean section, absence of fetal distress, no rupture of the membrane when entering the study, having physiological labor and delivery conditions
Exclusion criteria:unwillingness to continue collaborating in the study process, entering labor and nonphysiological conditions, precipitous labor, use of epidural anesthesia, fetus distress, meconium disposal, nausea and vomiting
Intervention groups
Group of date syrup: 6 milled dates with 150 ml of water which after clearing the filter are completely transparent and prepared in 150 cc jars.
Group of honey saffran syrup: 250 mg of saffron and 2/5 teaspoons of honey plus 150 ml of water are dissolved in 150 cc jars.
Control group: The usual care is given to the client and only plain water is provided if desired.
Main outcome variables
Duration of first, second and third of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190924044873N1
Registration date:2020-01-12, 1398/10/22
Registration timing:registered_while_recruiting
Last update:2020-01-12, 1398/10/22
Update count:0
Registration date
2020-01-12, 1398/10/22
Registrant information
Name
Hana Sohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4645
Email address
hana.sohrabi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-01, 1398/08/10
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of oral consumption of Date syrup with Honey Saffron syrup on progress of delivery in primiparous women
Public title
Comparison the effect of oral consumption of Date syrup with Honey Saffron syrup on progress of delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate
Cervical dilatation 4 cm when entering the study
Age between 18-35
Single pregnancy with cephalic presentation
Gestational age between 37-42 weeks
Estimated fetal weight between 2500-4000 gr
No indication of cesarean section
Absence of fetal distress
No rupture of the membrane when entering the study
Lack of known systemic diseases
No pregnancy complication such as preeclampsia, bleeding and infection
Having no history of infertility
Having physiological labor and delivery conditions
Have physical and mental health
No sensitivity to Dates, Honey and Saffron
Exclusion criteria:
Unwillingness to continue collaborating in the study process
Entering labor and nonphysiological conditions
Precipitous labor
Use of epidural anesthesia
Fetus distress
Meconium disposal
Nausea and vomiting
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Persons will be divided in to Honey Saffron syrup group, Palm syrup group and Control group according to simple randomization and envelopes. Participants will be given three envelopes in the package and selected by each of them to be placed in the respective group. It should be noted that it will be written in three envelopes of the group type ( Saffron syrup, Date palm syrup and Control group).
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 Kurdistan University of Medical Sciences.
Street address
Sanandaj.Pasdaran Street. Kurdistan University of Medical Sciences. School of Nursing and Midwifery.
City
Sanandaj
Province
Kurdistan
Postal code
6617913446
Approval date
2019-10-01, 1398/07/09
Ethics committee reference number
IR.MUK.REC.1398.149
Health conditions studied
1
Description of health condition studied
Progress of delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Progress of childbirth
Timepoint
Vaginal examinations will be done at baseline and then in the active phase of the first phase of the labor every 2 hours and in the second phase of the labor every 30 minutes. The recording of uterine contractions and fetal heart rate at baseline will be active every 30 minutes in the first phase of labor and every 15 minutes in the second phase.
Method of measurement
Partograph form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Honey saffron syrup group: Honey saffron syrup is made by Kurdistan Shafa medicine company. 250 ml of saffron and 2/5 teaspoons of honey from one of the prestigious factories ( for all sample of the same type) in 150 ml of maxed water are used. The syrup are made in opaque glass.The presentation of syrups at begining of the study (4 cm dilatation) and then every 30 to 60 minutes is extended once thr acrive phase of the first phase of labor is delivered as the patient wishes.
Category
Prevention
2
Description
Intervention group: Date syrup group: Date syrup is made by Kurdistan Shafa medicine company.Thus, to prepare it, 6 Bam black dates (same weight for all samples) after extracting the core in the blender thoroughly mix and then pass through the filter and completely smooth and without scrubbing mixed in 150.
Category
Prevention
3
Description
Control group: Routine care is done.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Roonak Shahoei
Street address
Sanandaj, Pasdaran Street, Kurdestan University of Medical Sciences.
City
Sanandaj
Province
Kurdistan
Postal code
6617913448
Phone
+98 87 3362 7636
Fax
+98 87 3366 0092
Email
Rshaho@yahoo.com
Web page address
http://muk.ac.ir/Page?pageId=33
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Sanandaj, Pasdaran Street, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617913448
Phone
+98 87 3362 7636
Fax
+98 87 3366 0092
Email
Rshaho@yahoo.com
Web page address
http://muk.ac.ir/Page?pageId=33
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Sanandaj, Psdaran Street, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617913448
Phone
0089 87 33627636
Fax
+98 87 3366 0092
Email
Rshaho@yahoo.com
Web page address
http://muk.ac.ir/Page?pageId=33
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Sanandaj, Pasdaran Street, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617913448
Phone
+98 87 3362 7636
Fax
+98 87 3366 0092
Email
Rshaho@yahoo.com
Web page address
http://muk.ac.ir/Page?pageId=33
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Sanandaj. Pasdaran Stesst. kurdistan University of Medical Sciences.
City
Sanandaj
Province
Kurdistan
Postal code
66135757
Phone
+98 87 3362 7636
Email
Rshaho@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is shared after anonymization.
When the data will become available and for how long
The access period beings 6 months after the results are published.
To whom data/document is available
Data will be available only to researchers working in academic and research institutions.
Under which criteria data/document could be used
Access to data requires compliance with professional ethics.
From where data/document is obtainable
Applicants can refer to the library of the School of Nutsing and Midwifery Kurdistan University of Medical Sciences or Dr. Roonak Shaoei for information.
Address:Kurdistan University of Medical Sciences.
Email:Rshaho@yahoo.com
tel:087-33627636
What processes are involved for a request to access data/document
The applicant can access the documents after the article is published.