1. Home
  2. Approved trials
  3. » فارسی

Comparision between the effects of castor oil and evening primrose oil on cervical ripening of Nuli Par women

Protocol summary

Study aim
Comparative determination of the effect of evening primrose and castor oil on cervical readiness in Noli Par women
Design
The research is a parallel quasi-experimental clinical trial. In this study, the information is in three groups, in group A (60 cc of castor oil), group B (1000 mg vaginal capsule of evening primrose) and in group C (control). No intervention is performed. Therefore, the present study is a study of three, with a test plan before and after.
Settings and conduct
The researcher, all mothers of 38 weeks of Noli Par, under the supervision of the doctor in question, are referred to the midwifery triage unit of Afshar Hospital for evaluation of inclusion and exclusion criteria. And evaluates the exit and determines the bishop score and asks the mothers to come again on the day of EDC (40th week of pregnancy). the samples are selected and then by the table of random numbers the samples are placed in three groups A, B and C In group A, 60 cc of castor oil is produced, in group B, 1000 mg vaginal evening primrose capsule is produced, and in group C, which is controlled.There is no intervention other than routine treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Iranian citizen Single twin BiShop scorebelow four Tendency to have a normal delivery Having a low-risk pregnancy Exclusion criteria: Use of any drugs or herbal medicines Any vaginal bleeding Having contractions Having a private midwife
Intervention groups
The samples are in groups A, B and C. In group A: 60 cc of castor oil, in group B: evening primrose (1000 mg vaginal evening primrose capsule) and in group C, which is controlled, no intervention other than routine care. It does not happen
Main outcome variables
Cervical ripening

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160809029281N3
Registration date: 2022-12-16, 1401/09/25
Registration timing: retrospective

Last update: 2022-12-16, 1401/09/25
Update count: 0
Registration date
2022-12-16, 1401/09/25
Registrant information
Name
Fateme Moshirenia
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3521 9358
Email address
f.moshirenia@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-13, 1400/09/22
Expected recruitment end date
2022-01-12, 1400/10/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision between the effects of castor oil and evening primrose oil on cervical ripening of Nuli Par women
Public title
Evaluation of the effect of castor oil and evening primrose on cervical ripening
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian citizenship Single twin BiShop score below four4 Tend to have a normal delivery a low-risk pregnancy (no diabetes, no preeclampsia, bleeding, etc.) Age 18-35 years Having h eight shorter than 150 cm Water bag closed Fetal weight according to sono2500-4000 No bleeding diseases Head displayFetal health according to sono Fetal health according to sono No known or systemic chronic diseases in the mother
Exclusion criteria:
Use of any narcotics or herbal medicines Any vaginal bleeding Having a midwife with a private
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected by easy sampling method and then they will be randomly divided into three groups: intervention 1 (60 cc of castor oil), intervention 2 (1000 cc of evening primrose vaginal capsule) and group 3 (control). And then the random allocation of samples will be such that 114 envelopes will be prepared and named equally with code 1, 2, and 3. The codes will be inside the envelopes and will be closed in the envelopes. Those who choose envelopes with code 1 will be in intervention group 1, those who choose envelopes with code 2 will be in intervention group 2, and those who will choose envelopes with code 3 will be in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants do not know how to intervene.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research Infertility Research Center - Shahid Sadoughi University of Medical Sci
Street address
Timsar fallahi Ave.,yazd Town
City
yazd
Province
Yazd
Postal code
8943163589
Approval date
2021-10-31, 1400/08/09
Ethics committee reference number
IR.SSU.RSI.REC.1400.015

Health conditions studied

1

Description of health condition studied
cervix ripening
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cervical ripening
Timepoint
40 weeks of pregnancy, 48 hours after intervention
Method of measurement
Determine the B-score score, which includes five characteristics: dilatation, effusion, fetal position, consistency, and cervical condition. The most common scoring system is to predict the success or failure of induction of labor.

Secondary outcomes

empty

Intervention groups

1

Description
After taking a stress-free test, the researcher is given group A 60 cc of castor oil (produced by Dineh Aromatic Company). Avoid other traditional methods to start labor and danger signs are taught according to the national protocol. The researcher provides the follow-up form to the samples. The subjects in each group are rejected up to 48 hours after the intervention in such a way that every 6-8 hours during the telephone call, the onset of contractions is asked in case of contractions (length one). At least 8 hours of contractions) refer to the desired hospitals and if the contractions do not start within 48 hours after the intervention, the research units in all three groups refer to selected hospitals for hospitalization.
Category
Treatment - Other

2

Description
Group B is given 1000 mg vaginal evening primrose capsule (Amin Iran Pharmaceutical Company). The dose of drugs is determined according to the studies performed by the pharmaceutical specialists of Amin Pharmaceutical Company and Dineh Iran Industrial Complex. Traditional abstinence to begin childbirth and danger signs are taught according to national protocol. The researcher provides the follow-up form to the samples. The subjects in each group are rejected up to 48 hours after the intervention in such a way that every 6-8 hours during the telephone call, the onset of contractions is asked in case of contractions (length one). At least 8 hours of contractions) refer to the desired hospitals and if the contractions do not start within 48 hours after the intervention, the research units in all three groups refer to selected hospitals for hospitalization.
Category
Treatment - Other

3

Description
Control group: group C does not involve any intervention other than routine treatment. Research units are instructed to avoid enema, laxatives, herbal or chemical drugs, or other traditional methods of initiating labor during this period, and danger signs are taught according to the national protocol. The researcher provides the follow-up form to the samples. The subjects in each group are rejected up to 48 hours after the intervention in such a way that every 6-8 hours during the telephone call, the onset of contractions is asked in case of contractions (length one). At least 8 hours of contractions) refer to the desired hospitals and if the contractions do not start within 48 hours after the intervention, the research units in all three groups refer to selected hospitals for hospitalization
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Afshar Hospital
Full name of responsible person
Fateme Moshirenia
Street address
Gomhori Blvd., YazdTown
City
Yazd
Province
Yazd
Postal code
8943163589
Phone
+98 35 3525 5011
Email
f.moshirenia@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behnaz Enjezab
Street address
Timsar Falahi Ave., yazd Town
City
yazd
Province
Yazd
Postal code
8943163589
Phone
+98 35 3824 1752
Email
f.moshirenia@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fateme Moshirenia
Position
Professor
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Timsar Fallahi Ave.yazd Town
City
yazd
Province
Yazd
Postal code
8943163589
Phone
+98 35 3521 1698
Email
f.moshirenia@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme Moshirenia
Position
Professor
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Timsar Fallahi Ave.,yazd Town
City
yazd
Province
Yazd
Postal code
8943163589
Phone
+98 35 3521 1698
Email
f.moshirenia@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme Moshirenia
Position
Professor
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Timsar Fallahi Ave.,yazd Town
City
yazd
Province
Yazd
Postal code
8943163589
Phone
+98 913 526 4607
Email
f.moshirenia@gmail.com

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
Loading...