Determining the effect of vaginal Evening Primrose capsule on Bishop score in nulliparous women.
Design
Clinical trial with a control group, community-based and pragmatic, with parallel groups, double-blind, randomized
Settings and conduct
Study population contains all the pregnant women who would refer to the health centers of Rafsanjan. So 86 women, with regard to the inclusion and exclusion criteria, would be enrolled in the study using convenient method and then would be allocated into two groups of control and intervention using simple randomization. Training about the method of placing the Primrose capsule and placebo in the posterior fornix would be conducted using a replica in the intervention and control groups, and they would be advised to use one Primrose capsule or placebo every night before sleeping from the 38th week of pregnancy until the birth symptoms occur. The participants and the individuals in charge of distributing the capsules would not be aware of the control and intervention groups’ allocation. Information about the Bishop score would be extracted from the delivery file of women and related forms would be completed.
Participants/Inclusion and exclusion criteria
The inclusion criteria: willingness to participate in the study, willingness to have vaginal delivery and being 18-35 years old
The exclusion criteria: not taking two consecutive capsules of Evening Primrose.
Intervention groups
Intervention group: Daily vaginal use of 1 capsule of prime Rose every night before bedtime from the 38th week of pregnancy until the time of delivery
Control group: Using placebo in the same manner as the intervention group
Main outcome variables
Bishop score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160308026971N4
Registration date:2018-06-10, 1397/03/20
Registration timing:registered_while_recruiting
Last update:2018-06-10, 1397/03/20
Update count:0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Marzeyeh Loripoor
Name of organization / entity
Rafsanjan University Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 4950
Email address
m.loripoor@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Rafsanjan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the Effect of vaginal Evening Primrose capsule on cervix preparation in nulliparous Women
Public title
Investigation the Effect of vaginal Evening Primrose capsule on cervical preparation for childbirth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclination to participate in the study
Tendency to normal delivery
Selection of Niknafs hospital for delivery
Mother’s age is 18-35 years
Gestational age 38 weeks based on first trimester Ultrasonography or reliable IMP
Single fetus with cephalic presentation The basis of the results of the last ultrasound
Nulliparality
the integrity of the embryonic membranes
Exclusion criteria:
Non-use of two successive capsules of Primrose
Primrose capsule susceptibility
Emergency intervention for maternal or embryonic reasons
Unwillingness of the research unit to continue cooperation
Vaginal bleeding
Presence of contraindications for use of Evening Primrose capsule (diseases associated with disorders Hemorrhagic agents, anticoagulant drugs, Patients with history of psychiatric disorders in the phenothiazine category, and epilepsy patients)
History of known chronic disease
Pregnancy complications such as Hydromenosis, Oligohydroamenia, Pre-eclampsia, Eclampsia
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randpm allocation in this study is simple randomization and its tool is a random number table. At first, the researcher referred to the public health centers of Rafsanjan (Nos. 1, 4, and 5). She chose all the eligible pregnant women in the apple system and, after telephone conversation with each of the women, explained the research, if Their willingness to participate in the study, each of them assigned a number, and then the random numbers table is used to select the members of the intervention and control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the research units and the clinical caregiver are unaware of any sample in which of the control and intervention groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University Medical Science
Street address
Imam Ali street, cenral department of Rafsanjan University Medical Science
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Approval date
2017-08-05, 1396/05/14
Ethics committee reference number
IR.RUMS.REC.1396.89
Health conditions studied
1
Description of health condition studied
Bishop Score
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bishop score
Timepoint
After intervention
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
The drug used in this study is soft Barich EPO capsule or Evening Primrose Oil capsule produced by Barich Essence Company. Each soft capsule contains 1000 mg of Evening Primrose Oil and 140-70 mg gamma linolenic acid (GLA). Each study unit in the intervention group is given 21 units. From the beginning of the 38th week of gestation until the day of delivery, one capsule of Evening Primrose Oil embeds in the posterior fornix.
Category
Treatment - Drugs
2
Description
Twenty-one placebos are presented to the control group in the same way as Evening Primrose Oil capsule, manufactured by the Barich Essence pharmaceutical company, From the beginning of the 38th week of gestation until the day of delivery, one placebo of Evening Primrose capsule embeds in the posterior fornix.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center No.1
Full name of responsible person
Motahare Najafi
Street address
Health Center No. 1, Imam Khomeini Street, Ghods Square
City
Rafsanjan
Province
Kerman
Postal code
7717653548
Phone
+98 34 3429 4081
Email
ava.man623@yahoo.com
2
Recruitment center
Name of recruitment center
Health center No.4
Full name of responsible person
Motahare Najafi
Street address
Health Center No. 4, West Amir Kabir Street, facing the children's park
City
Rafsanjan
Province
Kerman
Postal code
7718663316
Phone
+98 34 3432 5911
Email
marzeyehloripoor@yahoo.com
3
Recruitment center
Name of recruitment center
Health center No.5
Full name of responsible person
Motahare Najafi
Street address
Health Center No. 5, Kargar Street
City
Rafsanjan
Province
Kerman
Postal code
7716676788
Phone
+98 34 3425 3035
Email
1372najafi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Shamsizadeh
Street address
Imam Ali Blvd., Dept. of Research & Technology,Central Office of Rafsanjan University of Medical Sciences,
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Fax
+98 34 3428 0097
Email
alishamsy@gmail.com
Web page address
http://vcrt.rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Faculty of Nursing and Midwifery
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery University, Nursing Street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 5900
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 5900
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Marzeyeh Loripoor
Position
PHD Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com
Web page address
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