Comparing effect of oral and vaginal evening primrose oil on cervical ripening in pregnant women
Design
The clinical trial consists of 3 groups of 40 people, with control group with parallel groups and random allocation as block.
Settings and conduct
Women visited by the maternity ward of Hazrat-e-Valiasr hospital with criteria to enter the study, will be tested by bishop score.
if they have a Bishop score less than 4 or equal to it, they will be considered as intervention group. Then the intervention group will be divided into two groups. The first group will receive the medication for one week every 12 hours and then, once a day, until the onset of labor pains orally and the second one will receive the capsule vaginally. The control group will receive no intervention. Eventually after the intervention, once again the Bishop score will be tested and compared.
Participants/Inclusion and exclusion criteria
Entry requirements:
1- Low-risk primiparous women
2-Bishop score less than or equal to 4 at the time of drug administration
3-Cephalic presentation of the fetus
4. Single pregnancy
5. Gestational age 39 weeks
6. Normal test of fetal health assessment within the last 48 hours
Exclusion criteria:
A history of uterine surgery
Intervention groups
In intervention groups from 39 week of pregnancy, both groups will take the evening primrose oil capsules every 12 hours for one week, and after that once a day, until the onset of labor pains.
One of these groups will take the evening primrose oil capsules orally and the other group will take it vaginally. The control group will not receive any intervention.
Main outcome variables
Prepare cervix; improve labor; reduce duration of labor.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200118046180N1
Registration date:2020-07-23, 1399/05/02
Registration timing:retrospective
Last update:2020-07-23, 1399/05/02
Update count:0
Registration date
2020-07-23, 1399/05/02
Registrant information
Name
Parisa Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3242 6594
Email address
parisa.heydary@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of oral and vaginal evening primrose oil on cervical ripening in pregnant women
Public title
effect of evening primrose oil on cervical ripening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous and low-risk pregnant women
Gestational age 39 weeks
Cephalic presentation
bishop score of 4 or less
Single pregnancy
Exclusion criteria:
A history of uterine surgery
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:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be conducted in the form of Block Randomization. The first intervention group will be marked with the letter A, the second intervention group will be marked with the letter B, and the control group will be marked with the letter C. In the next step, six similar cards will be prepared and on each card, different rows of ABC letters (ABC, ACB, BCA,...) will be written, Each time a card is randomly selected, and after noting the order, it will be added again to the other cards. This process will continue until the sample size is completed.
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
Ethics committee of Tehran University of Medical Sciences
Street address
No.15, Shahid Tafakori Ave. Shohada Town
City
Bafq
Province
Yazd
Postal code
8971717479
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
IR.TUMS.FNM.REC.1398.134
Health conditions studied
1
Description of health condition studied
Cervical ripening
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cervical Preparation
Timepoint
Before the intervention and at the time of hospitalization for delivery
Method of measurement
Bishop's score measurement
Secondary outcomes
1
Description
Duration of hospitalization to delivery
Timepoint
Duration of hospitalization to delivery
Method of measurement
questionnaire
2
Description
Newborn Agar score
Timepoint
The first minute and Fifth minutes after birth
Method of measurement
questionnaire
3
Description
type of delivery
Timepoint
End of intervention
Method of measurement
questionnaire
4
Description
Need to induction
Timepoint
hospitalization until delivery
Method of measurement
questionnaire
Intervention groups
1
Description
First intervention group: In the first group, a bottle containing 1000 mg of evening primrose oil capsule made by Barij Essence Company will be given to mothers to use vaginally every week for 12 weeks from 39 weeks of pregnancy and then until the onset of labor pains once a day. If labor pains do not start or there are few contractions at the time of hospitalization, 10 oxytocin units will be induced.
Category
Treatment - Drugs
2
Description
second intervention group: In the second group, a bottle containing 1000 mg of evening primrose oil capsule made by Barij Essence Company will be given to mothers to use orally every week for 12 weeks from 39 weeks of pregnancy and then until the onset of labor pains once a day. If labor pains do not start or there are few contractions at the time of hospitalization, 10 oxytocin units will be induced.
Category
Treatment - Drugs
3
Description
Control group: In this group, no action will be taken before hospitalization for delivery, in case of non-onset of labor pains or low contractions of labor delivery, 10 units of oxytocin will be administered.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Valiasr Hospital
Full name of responsible person
Parisa Heydari Babdehooi
Street address
Bafq. valiasr Town
City
Bafq
Province
Yazd
Postal code
8971717479
Phone
+98 35 3317 2236
Email
parisa.heydary@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr MohamadAli Sahraiyan
Street address
Tohid Town, Doctor Mirkhani Ave
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
parisa.heydari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Parisa Heydari
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.15, Shahid Tafakori Ave. Shohada Town
City
Bafgh
Province
Yazd
Postal code
8971717479
Phone
+98 35 3242 6594
Fax
Email
parisa.heydary@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parisa Heydari
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.15, Shahid tafakori Ave. Shohada Town
City
Bafgh
Province
Yazd
Postal code
8971717479
Phone
+98 35 3242 6594
Fax
Email
parisa.heydary@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parisa Heydari
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.15, Shahid tafakori Ave. Shohada Town
City
Bafgh
Province
Yazd
Postal code
8971717479
Phone
+98 35 3242 6594
Fax
Email
parisa.heydary@yahoo.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