To determine the effectiveness of vaginal evening primrose capsules on ripening of the cervix of nulliparous pregnant women
Design
Clinical trials with drug and placebo control group, treatment-based, with parallel groups, blind, randomized by block method on 200 nuliparous pregnant women, enrolled between October 2018 and January 2020
Settings and conduct
This is a clinical trial study on nuliparous women attending to labor ward of Khaleej-e-fars hospital in Bandar Abbas. Participants will be randomly divided into two groups. One group will receive evening primrose oil vaginally and the other group will receive placebo. All participants will be blind to type of treatment. In order to blind the allocation, the pills will be divided into the opaque A and B packets and numbered. Participant, clinical caregiver, researcher, and outcome evaluator will be unaware of the type of intervention.The Bishop score of participants will be recorded before and 6 hours after the administration of drug and placebo.
Participants/Inclusion and exclusion criteria
Healthy low risk pregnant women with gestational age of 41 weeks attending to labor ward of Khaleej-e-fars hospital in Bandar Abbas
Intervention groups
Intervention group: Single dose of vaginal evening primrose oil capsule 1000 milligram
Control group: Single dose of vaginal placebo
Main outcome variables
Bishop score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181107041585N3
Registration date:2020-04-07, 1399/01/19
Registration timing:retrospective
Last update:2020-04-07, 1399/01/19
Update count:0
Registration date
2020-04-07, 1399/01/19
Registrant information
Name
Fatemeh Darsareh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3355 4515
Email address
famadarsareh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vaginal evening primrose capsules on ripening of the cervix of nulliparous pregnant women
Public title
Effect of vaginal evening primrose capsules on ripening of the cervix
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nuliparity
18-35 years old
BMI 18.5-24.9 Kg/m2
Singleton pregnancy
Gestational age of 41 weeks according to valid menstrual period or reliable first trimester pregnancy
Alive fetus
Cephalic presentation
Intact amniotic fluid sac
Reassure base non stress test
Bishop score less than 4
No regular uterine contractions
Exclusion criteria:
Abnormal fetal heart changes in labor
Abnormal maternal vital signs in labor
Mecounial amniotic fluid
Abnormal vaginal bleeding in labor
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple Random unit: Individual Randomization Tool: Sealed Envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the allocation, the pills will be divided into the opaque A and B packets and numbered. Participant, clinical caregiver, researcher, and outcome evaluator will be unaware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Shafa Ave
City
Bandar abbas
Province
Hormozgan
Postal code
7918796758
Approval date
2020-03-19, 1398/12/29
Ethics committee reference number
IR.HUMS.REC.1398.487
Health conditions studied
1
Description of health condition studied
Post term pregnancy
ICD-10 code
O48.0
ICD-10 code description
Post-term pregnancy
Primary outcomes
1
Description
Bishop score is the sum score of the place, dilation, effecment, position, and station of cervix to prognoses the ability of cervix for delivery
Timepoint
Before the administration of drugs and 6 hours after the administration of drug
Method of measurement
Bishop scoring scale
Secondary outcomes
1
Description
Method of delivery
Timepoint
After delivery
Method of measurement
Patients record
Intervention groups
1
Description
Intervention group: Administration of single dose of 1000 mg evening primrose oil capsule made by Natural-weber Canada company vaginally immediately after admission and after primery evaluation
Category
Treatment - Drugs
2
Description
Control group: Administration of single dose of placebo vaginally immediately after admission and after primary evaluation
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khaleeh fars hospital
Full name of responsible person
Fatemeh Darsareh
Street address
Pardis Blvd
City
Bandar abbas
Province
Hormozgan
Postal code
7919783141
Phone
+98 76 3367 0285
Email
famadarsareh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teymoor Aghamolaeie
Street address
Shafa Blvd
City
Bandar abbas
Province
Hormozgan
Postal code
7919783141
Phone
+98 76 3367 0285
Email
taghamolaeie@yahoo.com
Grant name
Technology and research vice-chancelory of Hormozgan University of Medical Sciences
Grant code / Reference number
970190
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Fatemeh Darsareh
Position
Midwife
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Pardis Blvd
City
Bandar abbas
Province
Hormozgan
Postal code
7919783141
Phone
+98 76 3367 0285
Email
famadarsareh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Fatemeh Darsareh
Position
Midwife
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Pardis Blvd
City
Bandar abbas
Province
Hormozgan
Postal code
7919783141
Phone
+98 76 3367 0285
Email
famadarsareh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Fatemeh Darsareh
Position
Midwife
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Pardis Blvd
City
Bandar abbas
Province
Hormozgan
Postal code
7919783141
Phone
+98 76 3367 0285
Email
famadarsareh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality
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