A Comparative investigation of the effect of oral vening primrose oil capsules with vaginal form before induction on Bishop's score, the success of induction, and some outcomes of labor in women.
Determination and Comparative investigation of the effect of oral with vaginal form evening primrose oil capsules before induction on Bishop's score, the success of induction and some outcomes of labor in women referred to the Niknafs Maternity hospital of Rafsanjan city in 2019
Design
Randomized clinical trial, phase 3, 100 samples with two intervention groups, without control group, double blind
Settings and conduct
This study is a double blind randomized clinical trial based on Bishop's score and number of normal vaginal delivery. The first intervention group will receive two Prime rose capsules (oral,1000 mg, daily) and the second intervention group will receive two capsules (vaginal ,1000 mg) at the time of induction. The location of this study is NickNafs Rafsanjan maternity hospital
Participants/Inclusion and exclusion criteria
1.Willingness to participate in the study
2. Compete Inform consent
3.Mother age of 18-35 years
4.Normal amniotic cyst
5.Normal ECG in the fetus
6. Lack of labor contraction
7. Low-risk pregnancies such as lack of a (placenta previa, diabetes, preeclampsia, decreased fetal movement, reduced amniotic fluid ...)
8. Single-fetus with a cephalic presentation based on the latest ultrasound results
9. Bishop score less than 6
10. Negative past medical history of known chronic diseases
11. Persian Race
Exclusion criteria:
1. The need for emergency intervention for maternal or fetal reasons before induction
2.Birth weight less than 2500 and above 4000 grams
Intervention groups
The first intervention group will receive two 1000 mg oral rose capsules and the second intervention group will receive two 1000mg vaginal prime rose capsules at the same time with induction
Main outcome variables
The mean Bishop score, Success of labor induction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044248N4
Registration date:2021-01-06, 1399/10/17
Registration timing:registered_while_recruiting
Last update:2021-01-06, 1399/10/17
Update count:0
Registration date
2021-01-06, 1399/10/17
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
2020-08-04, 1399/05/14
Expected recruitment end date
2021-03-04, 1399/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative investigation of the effect of oral vening primrose oil capsules with vaginal form before induction on Bishop's score, the success of induction, and some outcomes of labor in women.
Public title
A Comparative investigation of the effect of oral vening primrose oil capsules with vaginal form before induction on Bishop's score, the success of induction, and some outcomes of labor.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness for participant in the study
Willingness to normal vaginal delive
Mother age between 18-35 years
Normal amniotic cyst
Normal ECG of fetus
No labor contraction
Low risk pregnancy
Single-fetus
Cephalic presentation based on the latest ultrasound results
Bishop score less than 6
Iranian race
Selection of Niknafs Maternity Center of Rafsanjan as the place of delivery
Exclusion criteria:
Contraindications of Gelax consumption
Sensitivity to Gelax capsules
known history of psychological illness
Delivery complications such as polyhydramnios, oligohydramnios, preeclampsia, eclampsia, vaginal bleeding
History of having confirmed psychological disorders
The need for emergency intervention for maternal or fetal reasons before induction
Birth weight less than 2500 and above 4000 grams
Having labor contractions
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random classification by minimization method:
Among those who refer to the maternity hospital to induce labor, people who have the inclusion criteria, Will be selected as a research sample. In order to allocate individuals to groups A or B, the first person in each of the quadrupled stratums will be randomly entered into the study by flip a coin. To allocate the next samples to groups A or B, the sum of the number of samples, ie the
number of pregnancies and the bishop score, is considered in the quadrupled stratums, and the next sample will belong to the class that has the least sum. If the samples are equal in stratums, the same routine flip a coin will be repeated.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to be blind in this study, the pharmacist will put the medicines of groups A and B in the same-shape (uniform) packages and the prescription will be placed inside each package. The researcher will not know the type of medicines in these two groups. At first, the participants will be given the necessary explanations for participation and informed consent will be obtained.
Blinding will be performed for the statistical analyzer. After completing the statistical analysis, the pharmacist will be asked about the type of medicines of groups A or B. The clinician will not know which medicine belongs to group A or B.Vaginal examination will be performed by a clinical caregiver and the bishop score will be determined and participants will be referred to another research colleague for medication. The medicine will be given to the participant according to the number of pregnancies and bishop score with the minimization method. In the next step, the clinical caregiver who does not know about the groups of the medicines will perform the examinations two and four hours later and will record it in the file. The other research colleague will complete the checklist according to the file.
Placebo
Not 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
رفسنجان
Province
Kerman
Postal code
77179335777
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.RUMS.REC.1398.122
Health conditions studied
1
Description of health condition studied
Nornal vaginal delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The mean of Bishop's score
Timepoint
Determination of Bishop score before induction, two and four hours after induction
Method of measurement
The Bishop score table, which has five criteria including dilatation, effacement, fetal head station, softness, and position of the cervix during a vaginal examination. for scoring each of the first three criteria, take a score of 3-0, and each of the next two criteria, take a score of 2. -0.
Secondary outcomes
1
Description
The duration of the first stage of labor
Timepoint
From the onset of the active phase of labor to the complete opening of the cervix (measurements were taken every hour).
Method of measurement
Use checklist (written in the checklist every hour).
Intervention groups
1
Description
The first intervention group will receive two Prime rose capsules (oral,1000 mg, daily) made by Barich Essence Company, before induction.
Category
Treatment - Drugs
2
Description
The second intervention group will receive two Prime rose capsules (vaginal,1000 mg, daily) made by Barich Essence Company, before induction.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Nik Nafs Maternity center of Rafsanjan
Full name of responsible person
Leila Norouzian
Street address
21th Bostan Alley, Panzdah-e-Khordad Ave.
City
Rafsanjan
Province
Kerman
Postal code
7715764581
Phone
+98 34 3422 5494
Email
azamfateh65@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Alishamsizadeh
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
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?