A Comparative investigation of the effect of oral castor oil capsules and evening primrose oil 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

Determination and Comparative investigation of the effect of oral castor oil capsules and evening primrose oil 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

Randomized clinical trial, phase 3, 100 samples with two intervention groups, without control group, triple-blind.

This study is a triple-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 six Gylax capsules (oral,1000 mg) at the time of induction. The location of this study is NickNafs Rafsanjan maternity hospital.

Inclusion criteria: Willingness to participate in the study; Compete Inform consent ; Mother age of 18-35 years ; Normal amniotic cyst; Normal ECG in the fetus ; Lack of labor contraction; Low-risk pregnancies such as lack of a (placenta previa, diabetes, preeclampsia, decreased fetal movement, reduced amniotic fluid ...) ; Single-fetus with a cephalic presentation based on the latest ultrasound results; Bishop score less than 6; Negative past medical history of known chronic diseases; Persian Race Exclusion criteria: The need for emergency intervention for maternal or fetal reasons before induction; Birth weight less than 2500 and above 4000 grams

The first intervention group will receive two Prime rose capsules (oral,1000 mg, daily) and the second intervention group will receive six Gylax capsules (oral,1000 mg) at the time of induction.

The mean Bishop score, Success of labor induction

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.

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, but the participants will not know in which group (castor oil or evening primrose oil) they will be placed. The medicine will be given to participants as groups A or B. 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.

Confidentiality of informations