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Effect of honey saffron syrup on the progress of labor in nulliparous women admitted to childbirth ward of Imam Khomeini Hospital of Divandarreh in 2018

Protocol summary

Study aim
Determination of the effect of honey saffron syrup on the development of labor in primiparous women of Imam Khomeini Hospital of Divandareh in 2018
Design
Clinical trials; 90 specimens; Randomization; intervention groups 1 and 2; control group; using closed packages; Double blind
Settings and conduct
Researcher and research units are blind; Maternity ward of Imam Khomeini hospital
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 18-35 years; nulliparous; Gestational age 38-41 weeks; Spontaneous labor; Estimated fetal weight 2500 - 4000 grams; Cephalic presentation; Singleton; BMI 19.8 - 30 kg / m2; Reactive non-stress test; no use of oral glucose lowering drugs and insulin; anti-coagulants; nonsteroidal anti-inflammatory drugs; hypotensive drugs; benzodiazepines; barbiturates; narcotics; antidepressants and alcohol. like to participate in the study. Exclusion Criteria: History of uterus, cervix and vagina surgery; indications for cesarean section (abrupt; lack of progress; meconium aspiration; narrow pelvis; fetal distress); any abnormality in fetus; growth restriction and cardiovascular disease in fetus; Saffron sensitivity; History of mental illness; speech; hearing; visual and mental problems, mother's involvement in chronic and systemic diseases including increased blood pressure; diabetes; respiratory; cardiovascular; liver and endocrine diseases; crossing more than 12 hours of rupture of membranes; Unwilling to continue participation in the study
Intervention groups
First intervention group: Syrup prepared as a solution of 750 mg of saffron and 75 g of honey plus 450 ml of water Second intervention group: Syrup prepared as a combination of 750 mg of saffron and artificial sugar (15 g saccharin) with 450 ml of water Control group: Placebo syrup
Main outcome variables
Reduce the duration of the first, second and third stage of labor

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171210037807N1
Registration date: 2018-04-27, 1397/02/07
Registration timing: registered_while_recruiting

Last update: 2018-04-27, 1397/02/07
Update count: 0
Registration date
2018-04-27, 1397/02/07
Registrant information
Name
sheno ghaderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 7228
Email address
ghaderi.sheno@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2018-09-05, 1397/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of honey saffron syrup on the progress of labor in nulliparous women admitted to childbirth ward of Imam Khomeini Hospital of Divandarreh in 2018
Public title
Effect of honey saffron syrup on the progress of labor in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 35-18 years nulliparous Gestational age 38-41 weeks Spontaneous labor Estimated estimated fetal weight by the examiner or ultrasound of 2500 - 4000 grams Cephalic presentation Singleton The body mass index is 19.8 - 30 kg / m2 Reactive non-stress test The mother did not use oral and insulin glucose lowering drugs, anti-coagulants, nonsteroidal anti-inflammatory drugs, hypotensive drugs and drugs, benzodiazepines, barbiturates, narcotics, antidepressants, and alcohol. Willing to participate in the study
Exclusion criteria:
History of surgery on the uterus, cervix and delivery duct There are indications for cesarean section (abrupt, lack of progress, meconium, narrow pelvis, fetal distress) Fetus to any abnormalities, growth restriction and cardiovascular disease (fetus) Saffron sensitivity History of or mental illness, speech, hearing, visual and mental problems, mother's involvement in chronic and systemic diseases including increased blood pressure, diabetes, respiratory, cardiovascular, liver and endocrine diseases rupture of membranes more than 12 hours mother not willing to contine the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Using envelopes in the package will be allocated to three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Syrups will be shed in dishes of similar shape and color and the color of the syrups is the same in the three groups and encoded by the pharmacist. The codes will be provided to the supervisor only so the researcher and the research units will be unaware of the codes.
Placebo
Used
Assignment
Other
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
Pasdaran street
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
IR.MUK.REC.1396.368

Health conditions studied

1

Description of health condition studied
Childbirth
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
First stage of labor
Timepoint
The length of the first stage of labor, from 4 cm to 10 cm dilatation
Method of measurement
Timer

2

Description
Second stage of labor
Timepoint
The length of the second stage of labor from 10 cm dilatation to the exit of the embryo head
Method of measurement
timer

3

Description
Third stage of labor
Timepoint
Third stage of labor from exit of newborn to exit of placenta
Method of measurement
timer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Syrup prepared as a solution of 750 mg of saffron and 75 g of honey plus 450 ml of water
Category
Treatment - Drugs

2

Description
Intervention group: Syrup prepared as a combination of 750 mg of saffron and artificial sugar (15 g sodium saccharin) with 450 ml of water
Category
Treatment - Drugs

3

Description
Control group: Syrup with the same color as intervention wedges and no calories
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Sheno Ghaderi
Street address
Imam Khomeini Street
City
Divandareh
Province
Kurdistan
Postal code
6648456485
Phone
+98 87 3872 2930
Fax
Email
ghaderi.sheno1366sg@gmail.com
Web page address
http://www.muk.ac.ir/Muk/Hospitals/Imam_Divandare.aspx

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Roonak Shahooie
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
6654564555
Phone
+98 87 3323 2930
Email
ghaderi.sheno1366sg@gmail.com
Web page address
http://www.muk.ac.ir/Muk.aspx
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 shahoie
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3366 4664
Fax
+98 87 3366 4643
Email
rshaho@gmail.cpm
Web page address
http://muk.ac.ir/Muk.aspx

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Roonak Shahoie
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3366 4664
Fax
+98 87 3366 4643
Email
rshaho@gmail.com
Web page address
http://muk.ac.ir/Muk.aspx

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Roonak Rhahoie
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
6654564552
Phone
+98 87 3366 4664
Fax
+98 87 3366 4643
Email
rshaho@gmail.com
Web page address
http://www.muk.ac.ir/Muk.aspx

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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