Protocol summary
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Study aim
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The effect of sweet almond oil vaginal suppository on the ripening of the cervix in primiparous women
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Ripening of the cervix
General information
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Reason for update
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recording of the actual patient recruitment start and end dates.
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Acronym
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IRCT registration information
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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
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Registration date
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2023-07-12, 1402/04/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-06-27, 1402/04/06
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Expected recruitment end date
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2024-07-21, 1403/04/31
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Actual recruitment start date
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2023-07-19, 1402/04/28
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Actual recruitment end date
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2024-01-30, 1402/11/10
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Trial completion date
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empty
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Scientific title
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The effect of sweet almond oil vaginal suppository on the ripening of the cervix in primiparous women
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Public title
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The effect of sweet almond oil vaginal suppository on the ripening of the cervix
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
66
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-06-06, 1402/03/16
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Ethics committee reference number
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IR.MUMS.NURSE.REC.1402.029
Health conditions studied
1
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Description of health condition studied
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Ripening of the cervix
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ICD-10 code
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O80.0
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ICD-10 code description
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Spontaneous vertex delivery
Primary outcomes
1
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Description
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Ripening of the cervix
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Timepoint
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Before intervention,3 days,1 week after intervation and at the time of hospitalization
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Method of measurement
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Examination
Secondary outcomes
1
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Description
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onset of labor
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Timepoint
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Before intervention,3 days,1 week after intervation and at the time of hospitalization
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Method of measurement
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Examination
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available