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IRCT20190717044248N4 IRCT 2021-01-06 Rafsanjan University of Medical Sciences 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. 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. 2020-08-04 anticipated 100 Complete https://irct.ir/trial/48998 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Nornal vaginal delivery. Intervention 1: The first intervention group will receive two Prime rose capsules (oral,1000 mg, daily) made by Barich Essence Company, before induction. Intervention 2: The second intervention group will receive two Prime rose capsules (vaginal,1000 mg, daily) made by Barich Essence Company, before induction. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of information
public Mahdiyehsadat Hoseinipour
No. 37, 27th Alley, Mostafa Khomeini Ave., Rafsanjan
Rafsanjan Iran (Islamic Republic of) 7714646737 +98 34 3422 0393 shirinhoseinipour@yahoo.com Rafsanjan University of Medical Sciences scientific zahra saghafi
nursing and midwifry scool,sahely Blvd,Motahary Street
Rafsanjan Iran (Islamic Republic of) 7718145056 +98 34 2834 7100 zsaghafi@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 35 years Female 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 Treatment - Drugs Diagnosis The first intervention group will receive two Prime rose capsules (oral,1000 mg, daily) made by Barich Essence Company, before induction. The second intervention group will receive two Prime rose capsules (vaginal,1000 mg, daily) made by Barich Essence Company, before induction. 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. 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). Rafsanjan University of Medical Sciences Approved 2019-10-09 Ethics committee of Rafsanjan University of Medical Sciences Emam Ali Blvd, Rafsanjan رفسنجان Kerman Iran (Islamic Republic of)