Determining the effect of oral rose on bishop score and spontaneous onset of labor in nulliparous women referred to maternity hospitals in Zarand in 1400
Design
A clinical trial, with a control group, with parallel groups, without the possibility of blinding, on 120 patients, the rondomizer.org system is used for randomization.
Settings and conduct
Each mother in the intervention group is given a glass of rose water with a concentration of 24% of Zahra Rose Company and a measure of 10 ml to drink twice a day (morning and night) for 7 days. Bishop scores are measured before the intervention and on the seventh day and when you enter labor to give birth. In the control group, a glass of colorless and odorless water is given to mothers to consume twice a day (morning and night) for 7 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in the study, willingness to perform natural childbirth, choosing Zarand maternity hospitals as the place of delivery, being the first abdomen, not having uterine contractions, age 18-35 years, cephalic presentation, singleton pregnancy, gestational age 38 weeks Based on reliable first trimester ultrasound or IMP, no rupture of membranes, no placenta previa and intrauterine growth retardation
Exclusion criteria include: forgetting more than two uses of rose water, sensitivity to rose water and unwillingness to continue cooperation
Intervention groups
60 pregnant mothers first abdomen in 38-40 weeks of pregnancy
Main outcome variables
bishop score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181219042051N4
Registration date:2022-04-04, 1401/01/15
Registration timing:registered_while_recruiting
Last update:2022-04-04, 1401/01/15
Update count:0
Registration date
2022-04-04, 1401/01/15
Registrant information
Name
Zohreh Ghorashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
zghorashi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of oral rose-water on bishap score and spontaneous labour in primiparous women
Public title
Investigation the effect of oral rose-water on bishap score and spontaneous labour in primiparous women
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
All primiparous women aged 18 to 35 years
with singleton pregnancy
and gestational age 38 weeks
without uterine contractions
Exclusion criteria:
Forgetting more than two uses of rose water
sensitivity to rose water
and unwillingness to continue cooperation
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Computer Random Assignment: 120 numbers are given to randomizer.org to rank them randomly. Then the odd numbers would consider as the control group and the even numbers as the case group respectively. In this order, each woman who enters the study is placed in the case or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The rose is distributed by a midwife expert and the bishop score is measured before the intervention, on the 7th day and entering the labor by two midwives who are unaware of the intervention group (one blind)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Rafsanjan university of medical sciences
Street address
main office of Rafsanjan university of medical sciences. Rafsanjan. Iran
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2021-12-18, 1400/09/27
Ethics committee reference number
IR.RUMS.REC.1400.206
Health conditions studied
1
Description of health condition studied
low bishop score
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
bishop score
Timepoint
The modified bishop score is measured before the intervention, on the seventh day and when entering the labor
Method of measurement
Vaginal examination
Secondary outcomes
empty
Intervention groups
1
Description
Each of the mothers in the intervention group is given a glass of rose water with a concentration of 24% of Zahra rose water company and a measure with a capacity of 10 ml, which is taken twice a day (morning and night) for 7 days. Bishop scores are measured before the intervention and on the seventh day and when entering labor to give birth
Category
Treatment - Drugs
2
Description
Control group: there is no intervention in control group. Bishop scores are measured before the intervention and on the seventh day and when entering labor to give birth
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Maternity ward of Imam Ali Hospital in Zarand city
Full name of responsible person
Fereshteh Mokhtari
Street address
Kerman, Zarand, Jomhuri Eslami Blvd., Parstar St., Imam Ali Hospital
City
Zarand
Province
Kerman
Postal code
7761976551
Phone
+98 34 3342 5000
Fax
+98 34 3342 9515
Email
beazarand@yahoo.com
Web page address
http://emamali-zarand.tamin.ir/
2
Recruitment center
Name of recruitment center
Maternity ward of Sina Hospital in Zarand city
Full name of responsible person
Maryam Amiri
Street address
Jomhoori Eslami BLV. Sajadyeh roundabout. Zarand
City
Zarand
Province
Kerman
Postal code
7761819595
Phone
+98 34 3142 8000
Fax
+98 34 3142 8000
Email
sinazarand.hospital@yahoo.com
Web page address
https://zarandhcn.kmu.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza vazirinejad
Street address
Research deputy of Rafsanjan university of medical sciences
City
Rafsanjan
Province
Kerman
Postal code
7718696699
Phone
+98 34 3425 5900
Email
zghorashi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Zohreh Ghorashi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
parastar street. school of nursing midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718696699
Phone
003434255900
Email
zghorashi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Zohreh Ghorashi
Position
Rssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
parastar street. school of nursing midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718696699
Phone
+98 34 3425 5900
Email
zghorashi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Zohreh Ghorashi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Parastar street. school of nursing midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718696699
Phone
+98 34 3425 5900
Email
zghorashi@yahoo.com
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