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IRCT20190717044248N5 IRCT 2021-04-18 Rafsanjan University of Medical Sciences A comparative study on the effect of oral with vaginal of primrose oil capsule on bishap score and some prenatal outcomes A comparative study on the effect of oral and vaginal of primrose oil capsule on bishap score and some prenatal outcomes in nulliparous women 2020-08-05 anticipated 105 Complete https://irct.ir/trial/44110 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals who will have the inclusion criteria will be selected with the Convenience Sampling method. The Permuted block randomization will be used to allocate people to three groups. In this study, seven blocks (every block has 15 paces) will be created, so that after determining Individuals who will have the inclusion criteria, the first 15 people who enter the study will be divided into three groups randomly (assigning 5 people to each group), then the next 15 people will be divided into three groups randomly in the same way, and this method will be continued until the last block. The output of the software will be English letters (A, B & C) and each letter will be the representative of one of the intervention or control groups, Blinding description: At first, participants will be justified about the study, and will be informed consent will be taken. For blinding, the pharmacist will be 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 would not know about the content of packages (medicine or placebo). The medicine is also will be 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. 3 Normal Vaginal Delivery. Intervention 1: The first intervention group: Two capsules contains one gram of oral Primrose oil, made by Barich Essence Company, which patients consume from night to night starts from 38 weeks to delivery time. If a person forgets to consume for two days, it will be removed from the study. Intervention 2: The second intervention group will receive two Prime rose capsules (vaginal ,1000 mg, daily) made by Barich Essence Company. Participants will consume from night to night starts from 38 weeks to delivery time. If a person forgets to consume for two days, it will be removed from the study. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of information
public Fareeba Payhdar
Nursing and midwifery school, Sahely Blvd, Motahari Street
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3425 5900 f.payedar73@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) Willingness for participant in the study Willingness to normal vaginal 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 primrose oil capsule Sensitivity to primrose oil capsule 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 The first intervention group: Two capsules contains one gram of oral Primrose oil, made by Barich Essence Company, which patients consume from night to night starts from 38 weeks to delivery time. If a person forgets to consume for two days, it will be removed from the study. The second intervention group will receive two Prime rose capsules (vaginal ,1000 mg, daily) made by Barich Essence Company. Participants will consume from night to night starts from 38 weeks to delivery time. If a person forgets to consume for two days, it will be removed from the study. 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. 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)