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General information
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2023-07-19, 1402/04/28
2023-07-19 00:00:00
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2024-01-30, 1402/11/10
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recording of the actual patient recruitment start and end dates.
recording of the actual patient recruitment start and end dates.
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Recruitment centers
#1
Name of recruitment center - English: Omolbanin hospital
Name of recruitment center - Persian: بیمارستان ام البنین
Full name of responsible person - English: Doctor Masoumeh Mirteymouri
Full name of responsible person - Persian: دکتر معصومه میرتیموری
Street address - English: Omolbanin hospital, Ayatollah Bahjat 16, Ayatollah Bahjat Ave.
Street address - Persian: مشهد ، چهارراه زرینه، خیابان آیت الله بهجت، نبش آیت الله بهجت 16
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177899191
Phone: +98 51 3223 1061
Fax: +98 51 3223 1444
Email: MirteimouriM@mums.ac.ir
Web page address: https://woman.mums.ac.ir/
Name of recruitment center - English: Omolbanin hospital
Name of recruitment center - Persian: بیمارستان ام البنین
Full name of responsible person - English: Doctor Masoumeh Mirteymouri
Full name of responsible person - Persian: دکتر معصومه میرتیموری
Street address - English: Omolbanin hospital,16th Bahjat street, Ayatollah Bahjat avenue, Mashhad, Iran
Street address - Persian: مشهد ، چهارراه زرینه، خیابان آیت الله بهجت، نبش آیت الله بهجت 16
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177899191
Phone: +98 51 3223 1061
Fax: +98 51 3223 1444
Email: MirteimouriM@mums.ac.ir
Web page address: https://woman.mums.ac.ir/
Name of recruitment center - English: Omolbanin hospital Name of recruitment center - Persian: بیمارستان ام البنین Full name of responsible person - English: Doctor Masoumeh Mirteymouri Full name of responsible person - Persian: دکتر معصومه میرتیموری Street address - English: Omolbanin hospitalhospital,16th Bahjat street, Ayatollah Bahjat 16avenue, Ayatollah Bahjat Ave.Mashhad, Iran Street address - Persian: مشهد ، چهارراه زرینه، خیابان آیت الله بهجت، نبش آیت الله بهجت 16 City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9177899191 Phone: +98 51 3223 1061 Fax: +98 51 3223 1444 Email: MirteimouriM@mums.ac.ir Web page address: https://woman.mums.ac.ir/
Protocol summary
Study aim
The effect of sweet almond oil vaginal suppository on the ripening of the cervix in primiparous women
Design
The clinical trial has a control group, three blind strains with parallel and randomized groups. 66 mothers with 40 weeks of pregnancy are selected as primary and available samples and are placed in two intervention and control groups using simple random allocation on the web by the sequence created on the website www.randomizer.org.
Settings and conduct
The units will be selected among the mothers referring to the obstetric clinic of Umm al-Binin Hospital (S) and Shahid Hashminejad Hospital of Mashhad. According to the intervention or control group, the units use one vaginal suppository sweet almond oil 20% or placebo for 7 nights before going to bed. Both groups will be advised to visit the clinic 72 hours and one week after the start of the study in order to control and determine the Bishop's score if labor pains do not start. If labor pains do not start at the beginning of the 41st week, they will be admitted to the maternity hospital to terminate the pregnancy. People's codes are kept in closed envelopes for confidentiality.
Participants/Inclusion and exclusion criteria
conditions for entering : primiparous, maternal age between 18-35, gestational age 40 weeks, singleton pregnancy, cephalic fetal presentation, non-drug dependence, maternal body mass index in the range of18.5_30, Bishop's score of 6 or less, non-reactive stress test, impact water bag. conditions of not entering the study before randomization: allergy to sweet almond oil, medical and obstetric problems.
Intervention groups
The units of the intervention group use a vaginal suppository of sweet almond oil for 7 nights, and the units of the control group use a placebo for 7 nights. The consumption of these suppositories in both groups starts from 40 weeks of pregnancy.
Main outcome variables
Ripening of the cervix
General information
Reason for update
recording of the actual patient recruitment start and end dates.
Acronym
IRCT registration information
IRCT registration number:IRCT20230526058296N1
Registration date:2023-07-12, 1402/04/21
Registration timing:prospective
Last update:2026-06-06, 1405/03/16
Update count:1
Registration date
2023-07-12, 1402/04/21
Registrant information
Name
Parisa Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 903 832 2464
Email address
hoseinibp4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-27, 1402/04/06
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
2023-07-19, 1402/04/28
Actual recruitment end date
2024-01-30, 1402/11/10
Trial completion date
empty
Scientific title
The effect of sweet almond oil vaginal suppository on the ripening of the cervix in primiparous women
Public title
The effect of sweet almond oil vaginal suppository on the ripening of the cervix
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
primiparous women
18 to 35 years
Gestational age 40 weeks
Singleton pregnancy
Cephalic presentation
Body mass index 18.5 to 30
Intact fetal membranes
no drug addiction
Bishop score 6 or less
Reactive non-stress test
Exclusion criteria:
Sensitivity to sweet almond oil
Medical and obstetric problems
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
66
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The cases are selected as available and the allocation of eligible pregnant women to the intervention and control groups will be done randomly and with a random sequence created by the website www.randomizer.org. These sequences are produced as quadruple blocks with equal number of A and B (coded by A and B).
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug and placebo are blinded by the pharmacist. The researcher and the participants will not know the contents of the package. The desired suppositories will be prepared in the same size and color with a weight of 3 grams, and the coding on the envelopes (A and B) will be done by the pharmacist consultant. 33 participants in each group will randomly receive suppositories A or B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Assistance of Research and Technology of Mashhad University of Medical Sciences, Qurashi building, Daneshgah avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2023-06-06, 1402/03/16
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.029
Health conditions studied
1
Description of health condition studied
Ripening of the cervix
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
Ripening of the cervix
Timepoint
Before intervention,3 days,1 week after intervation and at the time of hospitalization
Method of measurement
Examination
Secondary outcomes
1
Description
onset of labor
Timepoint
Before intervention,3 days,1 week after intervation and at the time of hospitalization
Method of measurement
Examination
Intervention groups
1
Description
Intervention group: The intervention group uses one 20% sweet almond oil vaginal suppository every night before going to bed for 7 days after determining Bishop's score from the 40th week of pregnancy. If labor does not start, refer three days and one week later to determine Bishop's score and perform a non-stress test (NST). If the labor does not start until the 41st week, the mother will be referred to the maternity hospital to terminate the pregnancy.
Category
Other
2
Description
Control group: The control group uses a placebo every night before going to bed for 7 days after determining Bishop's score from the 40th week of pregnancy. If labor does not start, refer three days and one week later to determine Bishop's score and perform a non-stress test (NST). If the labor does not start until the 41st week, the mother will be referred to the maternity hospital to terminate the pregnancy.