]>
IRCT20190717044248N1 IRCT 2020-06-29 Rafsanjan University of Medical Sciences The effect of different doses of castor oil capsule (Gelax) on Bishop's score and some delivery outcomes A comparative study on the effect of various doses of castor oil capsule (Gelax) on bishap score and some prenatal outcomes in nulliparous women refer to Niknafs Rafsanjan maternity hospital in 2020-01-05 anticipated 90 Complete https://irct.ir/trial/44109 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random sampling; Random numbers table First, four centers from eight comprehensive health-care services centers in Rafsanjan will be selected as research units by a simple random method. Then, through the SIB system, the list of nulliparous pregnant women will be determined and will call with them, and among them who have inclusion criteria and willing to participate in the study will be determined as the final list. Then people will be classified into two intervention groups and one control group (A or B or C) based on the random numbers table, Blinding description: For blinding, the pharmacist is 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 does not know about the content of packages (medicine or placebo). The medicine is also 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. At first, participants are justified about the study, and informed consent will be taken, but they are unaware of the content of packages (medicine or placebo). The clinical caregiver is also unaware of which A_B_C group contains each medicine. The researcher re-evaluated the 35-week pregnant mothers who have inclusion criteria and at 37 weeks for obtaining castor oil referred them to the distributor of Gelax packages, who were unaware of the contents of the A-B-C packages and according to random number table, one of the ABC groups is assigned to each participant. Another subcontractor is following up on the medical use plan of participants, and after the delivery, the other coworker will write the items research variables on the checklist based on the contents of the delivery file medical history. After completing the statistical analysis, the content of packages (medicine or placebo) will be asked from pharmacists. 3 Bishop's score, Maternal and Neonatal outcomes. Intervention 1: The first intervention group of use Six Gelax capsules contains one gram or one thousand milligrams of castor oil, made by Barich Essence Company, which they consume from noon to noon ant starts from 38 weeks to delivery time. If a person forgets to consume for two days, it will be removed from the study.The reason for using Gelax instead of castor oil is its better taste, which is better for eating. Intervention 2: The second intervention group of use three Gelax capsules contains one gram or one thousand milligrams of castor oil, made by Barich Essence Company, which they consume from noon to noon ant starts from 38 weeks to delivery time. If a person forgets to consume for two days, it will be removed from the study.The reason for using Gelax instead of castor oil is its better taste, which is better for eating. Intervention 3: The control group of use three Gelax capsules contains one gram or one thousand milligrams of sunflower oil, made by Barich Essence Company, which they consume from noon to noon ant starts from 38 weeks to delivery time. If a person forgets to consume for two days, it will be removed from the study.The reason for using Gelax instead of castor oil is its better taste, which is better for eating. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of information
public Azam Fatehzadeh
6th Alley, Keshavarz Ave, Bahraman
Rafsanjan Iran (Islamic Republic of) 5967377441 +98 34 3425 5897 azamfateh65@gmail.com Rafsanjan University of Medical Sciences scientific Zahra Saghafi
Nursing and midwifery school, Sahely Blvd, Motahari Street
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3425 5900 saghafiz@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Inform consent for participant in the study Willingness to normal vaginal delivery Selection of Niknafs Maternity Center of Rafsanjan as the place of 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 18 years 35 years Female Contraindications of Gelax Sensitivity to Gelax capsules 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 Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group of use Six Gelax capsules contains one gram or one thousand milligrams of castor oil, made by Barich Essence Company, which they consume from noon to noon ant starts from 38 weeks to delivery time. If a person forgets to consume for two days, it will be removed from the study.The reason for using Gelax instead of castor oil is its better taste, which is better for eating. The second intervention group of use three Gelax capsules contains one gram or one thousand milligrams of castor oil, made by Barich Essence Company, which they consume from noon to noon ant starts from 38 weeks to delivery time. If a person forgets to consume for two days, it will be removed from the study.The reason for using Gelax instead of castor oil is its better taste, which is better for eating. The control group of use three Gelax capsules contains one gram or one thousand milligrams of sunflower oil, made by Barich Essence Company, which they consume from noon to noon ant starts from 38 weeks to delivery time. If a person forgets to consume for two days, it will be removed from the study.The reason for using Gelax instead of castor oil is its better taste, which is better for eating. 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. The frequency of spontaneous onset of labor. Timepoint: Time of delivery. Method of measurement: Check list. Comparomisation the frequency of spontaneous labor onset. Timepoint: Delivery duration. Method of measurement: Using checklist. 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. Method of measurement: Checklist. Rafsanjan University of Medical Sciences Approved 2019-06-17 Ethics committee of Rafsanjan University of Medical Sciences Emam Ali Blvd, Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)