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

Determining the mean Bishop's score and some delivery outcomes between intervention and control groups

Randomized Clinical Trial with two intervention groups and one control group; Three blindsides; Parallel groups. Randomization is done with a random numbers table.

In this randomized clinical trial, the statistical population Includes all nulliparous pregnant women. The sample size based on the statistical formula is thirty people in each group. The sampling is done by using the random numbers table. The study will include two intervention groups and one control group and it is triple-blind

Inclusion criteria: Willingness to normal vaginal delivery Selection of Niknafs Maternity Center of Rafsanjan as the place of delivery Mother age: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 Gelax Sensitivity to Gelax capsules Known history of psychological disorders Delivery complications such as polyhydramnios, oligohydramnios, preeclampsia, eclampsia, vaginal bleeding History of having confirmed psychological disorders

The intervention group consumes 6 Gelax capsules contains one gram of castor oil daily. The second intervention group consumes 3 Gelax capsules contains one gram of castor oil daily. The control group consumes three Placebo capsules "similar to Gelax capsules" and containing one gram of sunflower oil

Bishop's score and some delivery outcomes such as; The length of the first stage of delivery; The length of the second stage of childbirth; Frequency of NVD; Instrumental delivery; Meconium; The need to induction

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.

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.

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