Protocol summary

Summary
The aims of this double blind trial are to examine the effect of saffron syrup on labor pain severity and intensity of anxiety (primary outcomes) and duration of labor phases, hemoglobin, hematocrit, delivery experience score, woman satisfaction, amount of oxytocin used, and newborn bilirubin (secondary outcomes) in primiparous women. Ninety six low- risk women with gestational age of 38 to 41 weeks, referring to the 29 Bahman hospital in Tabriz, will be randomized into one of three groups: each receiving 80 to 240 ml syrup; containing 250 to 750 mg saffron and palm sugar, 250 to 750 mg saffron and artificial sugar, or placebo; using block randomization with block sizes of 3, 6 and 9, determined with a computerized program. A person not involved in the recruitment and data collection will determine allocation sequence and will number bottles containing the syrups identical in terms of color, taste and smell. After getting written informed consent and gathering baseline data, participants will take 80 ml of the syrup (made by Yashil drug company, Aras) when cervical dilation is around 3 to 4 cm and there are at least three uterine contractions in 10 minutes lasting for 45 to 60 seconds. It will be repeated every two hours for maximum three doses considering pain intensity, uterine contraction, and pattern of fetal heart rate. Severity of pain will be assessed using pain visual analogue scale (VAS) and intensity of anxiety will be examined by the state Spielberger inventory and VAS.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201507073706N26
Registration date: 2016-02-03, 1394/11/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-03, 1394/11/14
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-02-01, 1394/11/12
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of saffron syrup on the labor pain intensity, anxiety and duration of labor in primiparous women: a randomized controlled trial
Public title
The effect of saffron syrup on the labor pain intensity, anxiety and duration of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged 18 to 35 years; nulliparous; gestational age of 38 to 41 weeks; spontaneous onset of labor; singleton pregnancy with estimated fetal weight of 2500 to 4000 grams and cephalic presentation; no use of any herbal and anti anxiety drugs in the past 12 hours; reactive non stress test; body mass index of 19.8 to 30 kg/m²; having 8 years education or higher. Exclusion criteria: history of surgery on the uterus, cervix or vagina; allergy to saffron; known chronic diseases including hypertension, diabetes, diseases of the respiratory, cardiovascular, endocrine, etc.; history of mental illnesses; speech, hearing, visual or mental problems; known indications for caesarean section; premature rupture of membranes for more than 12 hours; any known fetal abnormalities; known fetal growth retardation
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: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Research Deputy, 3rd floor, Centeral building No 2 , Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Postal code
Approval date
2015-12-07, 1394/09/16
Ethics committee reference number
TBZMED.REC.1394.780

Health conditions studied

1

Description of health condition studied
Normal labor and delivery
ICD-10 code
080.0
ICD-10 code description
Spontaneous vertex delivery

Primary outcomes

1

Description
Severity of labor pain
Timepoint
every one hour from about 3 cm cervical dilation to the end of the second stage of labor; one and 18 to 24 hours after delivery
Method of measurement
visual analogue scale (VAS) for pain

2

Description
Intensity of anxiety
Timepoint
at baseline, 3 to 4 hours after starting intervention, and 18 to 24 postpartum
Method of measurement
Spielberger state questionnaire and visual analogue scale for anexity

Secondary outcomes

1

Description
Duration of first stage of labor (active phase)
Timepoint
from 4 cm to 10 cm cervical dilatation
Method of measurement
Partogramm form

2

Description
Duration of second stage of labor
Timepoint
from 10 cm cervical dilation to delivery
Method of measurement
Partogramm form

3

Description
Duration of third stage of labor
Timepoint
immediately after birth to expultion of placenta and fetal membranes
Method of measurement
Partogramm form

4

Description
Hemoglobin
Timepoint
at baseline and 18 to 24 hours after birth
Method of measurement
labratory test

5

Description
Score of delivery experience
Timepoint
18 to 24 hour after delivery
Method of measurement
delivery experience questionnaire

6

Description
Woman satisfaction rate
Timepoint
18 to 24 hour after delivery
Method of measurement
one question with likert options

7

Description
Amount of oxytocin used
Timepoint
during the intervention
Method of measurement
observation

8

Description
Hematocrit
Timepoint
at baseline and 18 to 24 hours after birth
Method of measurement
labratory test

9

Description
Newborn bilirubin
Timepoint
18 to 24 hours after delivery
Method of measurement
Billi Check device

Intervention groups

1

Description
The first intervention group: 80 to 240 ml syrup (made by Yashil drug company, Aras)containing 750 mg saffron and 200 mg of sugar palms in 240 ml syrup. 80 ml of the syrup will be taken when cervical dilation is around 3 to 4 cm and there are at least 3 uterine contractions in 10 minutes lasting for 45 to 60 seconds. It will be repeated every two hours for maximum three doses considering pain intensity, uterine contraction, and pattern of fetal heart rate.
Category
Treatment - Drugs

2

Description
The second intervention group: 80 to 240 ml syrup (made by Yashil drug company, Aras) containing 750 mg saffron and artificial sugar (Isonalt) in 240 ml syrup. 80 ml of the syrup will be taken when cervical dilation is around 3 to 4 cm and there are at least 3 uterine contractions in 10 minutes lasting for 45 to 60 seconds. It will be repeated every two hours for maximum three doses considering pain intensity, uterine contraction, and pattern of fetal heart rate.
Category
Treatment - Drugs

3

Description
Control group: 80 to 240 ml syrup (made by Yashil drug company, Aras) containing placebo of saffron and artificial sugar (Isonalt) in 240 ml syrup (identical in color, smell and taste with the saffron syrups. 80 ml of the syrup will be taken when cervical dilation is around 3 to 4 cm and there are at least 3 uterine contractions in 10 minutes lasting for 45 to 60 seconds. It will be repeated every two hours for maximum three doses considering pain intensity, uterine contraction, and pattern of fetal heart.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
29 Bahman Hospital, Tabriz
Full name of responsible person
Roghayeh Mohammadie Rad
Street address
29 Bahman Hospital, 29 Bahman Blvd, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad-Reza Rashidi
Street address
Research Deputy, 3rd floor, Centeral building No 2 , Tabriz University of Medical Sciences, Golgasht st; Tabriz
City
Tabriz
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, Tabriz 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 & Midwifery Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Roghayeh mohammadie rad
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariatie Ave., Tabriz, Postal code: 5138947977
City
Tabriz
Postal code
Phone
+98 41 3479 6969
Fax
Email
rmradobs@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariatie Ave., Tabriz, Postal code: 5138947977
City
Tabriz
Postal code
Phone
+98 41 3479 6969
Fax
Email
alizades@tbzmed.ac.ir, mhammadalizadehs@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariatie Ave., Tabriz, Postal code: 5138947977
City
Tabriz
Postal code
Phone
+98 41 3477 2699
Fax
+98 41 3479 6969
Email
alizades@tbzmed.ac.ir
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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