The purpose of this randomized clinical trial study is to determine the effect of rosewater on cervical ripening in nulliparous women.
Design
A clinical trial study, with a control group, randomized allocation of 60 eligible pregnant women.
Settings and conduct
The participants were nulliparous pregnant women referring to Sayed Mostafa Khomeini Hospital, Tabas and eligible for inclusion in the study. The study lasts for 1 week from the gestational age 40 weeks, which is assessed before, three days and seven days after the start of the intervention, the bishop score and the risk symptoms.
Participants/Inclusion and exclusion criteria
The study population included 60 nulliparous women, 18 to 35 years old with a gestational age of 40 weeks, a Bishop score of 4 or less, and a low-risk pregnancy.
Intervention groups
Study in two groups: 1- Rosewater, which for one week after 40 weeks of gestation, daily consumes 5 ml of rose water. 2- Control group (routine care).
Main outcome variables
Cervical ripening
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180904040952N1
Registration date:2018-12-12, 1397/09/21
Registration timing:prospective
Last update:2018-12-12, 1397/09/21
Update count:0
Registration date
2018-12-12, 1397/09/21
Registrant information
Name
Reihaneh Jarrahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3283 1661
Email address
jarrahir951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rosewater on cervical ripening in nulliparous women
Public title
The effect of rosewater on cervical ripening
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Residence in Tabas city
Age between 18 to 35 years
Nulliparous women with 40 weeks gestational age
Singleton pregnancy with cephalic presentation
Bishop score less than or equal 4
Intact amniotic sac
Normal pattern of fetal heart rate
The natural number of fetal movements or reactive non-stress test
Estimated fetal weight between 2500 to 4000
Exclusion criteria:
The presence of medical and obstetric problems in the present pregnancy
Patients with previous cesarean section or hysterotomy
Placenta previa and history of third trimester hemorrhage
Pelvic examination, intercourse and stimulation of the nipple during the last 24 hours or during the study
Laxatives, herbal, chemical, or traditional methods to start a labor within the last 24 hours or during the study
Irregular consumption or non-use of rose water during one week of study
Delivery in a central location other than Tabas Hospital
Patient intolerance
Regular uterine contractions
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the samples are selected based on the target, then they will be assigned to the intervention and control groups using the permutation blocks method. This allocation will occur with the use of software and without the involvement of human factors( Random Allocation software).
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
The Ethics Committee of the Mashhad Medical Science University
Street address
Qureishi building, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-951
Approval date
2018-12-02, 1397/09/11
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.057
Health conditions studied
1
Description of health condition studied
Cervical ripening
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cervical ripening measurement
Timepoint
Before the intervention, three days and seven days after the beginning intervention
Method of measurement
Cervical Bishop score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For 7 days, once a day, the amount of 5 ml of rose water of Kashan (with 24% of the essential oil of Damask rose) drink at a specified hour of the day. The first examination and check of contraction is when entering the study. Then, on the third and seventh day after the intervention, will be performed. Also, three days after the start of the intervention, the NST is done.
Category
N/A
2
Description
Control group: In the control group, routine care is performed. The first examination and check of contraction is when entering the study. Then, on the third and seventh day after the intervention, will be performed. Also, three days after the start of the intervention, the NST is done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Seyyed Mostafa Khomeini Hospital
Full name of responsible person
Dr. Elham Esform
Street address
Shahid Seyyed Mostafa Khomeini Hospital, Motahari Blvd, Tabas Golshan
City
Tabas
Province
South Khorasan
Postal code
9791652871
Phone
+98 56 3283 1661
Email
jarrahir951@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Qureishi building, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-951
Phone
+98 51 3859 1511
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Reihaneh Jarrahi
Position
Master of science student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Bahonar Alley 6, Shahid Bahonar Blvd, Golshan Tabas
City
Tabas
Province
South Khorasan
Postal code
9791737979
Phone
+98 56 3283 1661
Email
jarrahir951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
BiBi Sedigheh Shariat Moghani
Position
Faculty of member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ebne Sina St, Daneshgah Ave, Mashhad
City
Mashhad
Province
South Khorasan
Postal code
991319739
Phone
+98 51 3859 1511
Fax
Email
shariatmoghanis@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reihaneh Jarrahi
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
6 Shahid Bahonar Ave., Shahid Bahonar Blvd.,Tabas(Golshan) Town
City
Tabas
Province
South Khorasan
Postal code
9791737979
Phone
+98 56 3283 1661
Fax
Email
jarrahir951@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available