A comparative the effect of primrose oral and vaginal capsule on Bishop score and some delivery outcomes in primiparous women referring to the NiknafsRafsajan maternity hospital
Design
Randomized Clinical Trial with two intervention groups and one control group; Three blindsides; Parallel groups; Permuted block randomization
Settings and conduct
The statistical population of the research; Includes all nulliparous pregnant women referring to Comprehensive health service centers in Rafsanjan. The sample size will be estimated based on the statistical formula (35 people in each group). This research will be a triple-blind study. In order to blinding, the pharmacist will be asked to define the medicines and placebo with group A_B_C and will put the prescription of them inside each package. Blinding will be done for the researcher, samples, clinical caregiver, and analyzer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to normal vaginal delivery; Mother age:18-35 years; Pregnancy age: 38 weeks based on reliable first-trimester ultrasound; Single-fetal with a cephalic presentation based on the latest ultrasound results.
Exclusion criteria: oligohydramnios; preeclampsia; eclampsia; vaginal bleeding.
Intervention groups
The first intervention group consumes two oral capsules contains one gram of Primrose oil daily.
The second intervention group consumes two vaginal capsules contains one gram of Primrose oil daily.
The control group consumes two Placebo capsules "similar" and containing one gram of sunflower oil
Main outcome variables
Bishop's score; The length of the first stage of delivery; The length of the second stage of childbirth; Frequency of
normal vaginal delivery; Instrumental delivery; Meconium aspiration; Need to induction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044248N5
Registration date:2021-04-18, 1400/01/29
Registration timing:retrospective
Last update:2021-04-18, 1400/01/29
Update count:0
Registration date
2021-04-18, 1400/01/29
Registrant information
Name
Zahra Saghafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
z.saghafi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of oral and vaginal of primrose oil capsule on bishap score and some prenatal outcomes in nulliparous women
Public title
A comparative study on the effect of oral with vaginal of primrose oil capsule on bishap score and some prenatal outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness for participant in the study
Willingness to normal vaginal delivery
Mother age between 18-35 years
Pregnancy age: 38 weeks based on reliable first-trimester ultrasound or last menstrual period
Single-fetal with a cephalic presentation based on the latest ultrasound results
Exclusion criteria:
Contraindications of primrose oil capsule
Sensitivity to primrose oil capsule
known history of psychological illness
Delivery complications such as polyhydramnios, oligohydramnios, preeclampsia, eclampsia, vaginal bleeding
History of having confirmed phsycological disorders
Having any psychological disorders in the time of participation
Having epilepsy
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals who will have the inclusion criteria will be selected with the Convenience Sampling method.
The Permuted block randomization will be used to allocate people to three groups.
In this study, seven blocks (every block has 15 paces) will be created, so that after determining Individuals who will have the inclusion criteria, the first 15 people who enter the study will be divided into three groups randomly (assigning 5 people to each group), then the next 15 people will be divided into three groups randomly in the same way, and this method will be continued until the last block.
The output of the software will be English letters (A, B & C) and each letter will be the representative of one of the intervention or control groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
At first, participants will be justified about the study, and will be informed consent will be taken.
For blinding, the pharmacist will be asked to identify the medicine and placebo
with the A_B_C group and the prescription in each package will be placed. So that the researcher would not know about the content of packages (medicine or placebo). The medicine is also will be given to participants as A or B or C, and participants will not be informed of the content of packages (medicine or placebo).
This blinding will also be available for the analyzer, and after finishing the statistical analysis the content of packages (medicine or placebo) will be asked from pharmacists.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Emam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
77179335777
Approval date
2019-06-17, 1398/03/27
Ethics committee reference number
IR.RUMS.REC.1398.052
Health conditions studied
1
Description of health condition studied
Normal Vaginal Delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean Bishop score
Timepoint
It will be measured in active phase of delivery time.
Method of measurement
Bishop score is obtained by scoring the five criteria of dilatation, effacement, fetal head station, softness, and cervical position during vaginal examination. Accordingly, each of the first three criteria is given a score of 0-3 and each of the following two criteria is given a score of 0-2.
2
Description
The frequency of spontaneous onset of labor
Timepoint
Time of delivery
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: Two capsules contains one gram of oral Primrose oil, made by Barich Essence Company, which patients consume from night to night starts from 38 weeks to delivery time. If a person forgets to consume for two days, it will be removed from the study.
Category
Treatment - Drugs
2
Description
The second intervention group will receive two Prime rose capsules (vaginal ,1000 mg, daily) made by Barich Essence Company. Participants will consume from night to night starts from 38 weeks to delivery time. If a person forgets to consume for two days, it will be removed from the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Niknafs maternity center of Rafsanjan
Full name of responsible person
Zahra Hajbagheri
Street address
No. 54, 16th Alley, South Meraj Ave.
City
Rafsanjan
Province
Kerman
Postal code
7719655585
Phone
+98 34 3422 2321
Email
azamsharifi.967@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Deputy of research and technology, Building Num 3, Central Organization of University of Medical Sciences, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718146890
Phone
+98 34 2834 7200
Email
vcrt@rums.ac.ir
Grant name
Rafsanjan University of Medical Sciences
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Fareeba Payhdar
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and midwifery school, Sahely Blvd, Motahari Street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
f.payedar73@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Zahra Saghafi
Position
Totur
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing and midwifery school, Sahely Blvd, Motahari Street