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IRCT20200316046795N1 IRCT 2020-04-19 Sanandaj University of Medical Sciences Effect of oral evening primrose capsules on ripening of the cervix and progress of delivery Effect of oral evening primrose capsules on ripening of the cervix and progress of delivery in primiparous women 2020-05-21 anticipated 112 Complete https://irct.ir/trial/47008 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Individuals will be divided into intervention and control groups using the quadratic block formation method. A code to intervention (using capsules of evening primrose) and Code B to the control group (using placebo) will be allocated. The four blocks will then be sampled in six different modes (AABB, ABAB, ABBA, BBAA, BABA and BAAB), Blinding description: This research is a with the one-blind randomized trial method (participants will be unaware of the contents of the capsules). For this purpose to observe the ethical issues of the research, after the necessary explanations about the purpose and how to conduct the study to pregnant mothers, informed consent is obtained from them. Samples are divided into two equal groups of medicine and placebo with the randomized allocation method. Each of the participants will be given a bottle containing 14 1000mg oral evening primrose capsules (2 capsules per day, each 12 twelve hours for a week) or the placebo containing 14 placebo capsules containing canola oil. The color and shape of these capsules are similar to the intervention group. 3 Ripening of the cervix and progress of labor. Intervention 1: Intervention group: Capsule of evening primrose oil group: Evening primrose oil capsules are produced by pharmaceutical companies Barij. Providing a capsule in the beginning of the study, if the criteria for entry into the study. Each of the participants in the intervention group given to a bottle containing 14 1000mg oral evening primrose capsules (2 capsules per day, each 12 twelve hours for a week). Intervention 2: Control group: Placebo group: The capsules used for the control group are prepared by the researcher that the color and shape of these capsules are similar to the intervention group. Providing a capsule in the beginning of the study, if the criteria for entry into the study. Each of the participants in the control group given to a bottle containing 14 plasbo capsules containing canola oil (2 capsules per day, each 12 twelve hours for a week). Yes - There is a plan to make this available What will be shared: All data can be shared after persons have not been recognized. When: Data access is 6 months after publish the results. To whom: Data will only be available to researchers working at academic and scientific institutions. Conditions: Access to data requires observe of professional ethics fundamental. Where to obtain: Applicants can refer to the library of the Faculty of Nursing and Midwifery of Kurdistan University of Medical Sciences or Dr. Roonak Shahoei to receive the data. Address: Kurdistan University of Medical Sciences Email: Rshao@yahoo.com Phone:087- 33627636 How to obtain: The documents applicant can access that after the article is published. Comments:
public Roonak Shahoei
Sanandaj, Pasdaran Street, Kurdistan University of Medical Sciences, School of Nursing and Midwifery
Sanandaj Iran (Islamic Republic of) 6617913448 +98 87 3362 7636 Rshaho@yahoo.com Sanandaj University of Medical Sciences scientific Roonak Shahoei
Sanandaj, Pasdaran Street, Kurdistan University of Medical Sciences, School of Nursing and Midwifery
Sanandaj Iran (Islamic Republic of) 6617913448 +98 87 3362 7636 Rshaho@yahoo.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to participate in the study Being primiparous Literacy for reading and writing Age 18 to 35 years old Term pregnancy age (gestational age 39 weeks to 39 weeks and 6 days) based on first trimester ultrasound Single-pregnancy whit cephalic presentation live fetus Having a normal pelvis with a gynecologist's diagnosis The estimated weight of the fetus is between 4000-2500 grams Bishop score lower than or equal to 4 Intact membranes Healthy pregnant women (without known disease, surgery or pregnancy complications such as placental abruption, placenta previa or vasoprevia , preeclampsia or no fetal anomaly) No ban on the use of evening primrose oil (hemorrhagic disorders, consuming anticoagulants, individuals with a history of schizophrenia, epilepsy and consumer phenothiazine) No structural cervical anomalies Height above 150 cm Lack of alcohol and opioids Avoid using laxatives and any herbal medication prior to study 18 years 35 years Female Mother's unwillingness to continue cooperation in the research Consumption of less than two capsules per day (problems with checklist of oral capsules) Use of epidural anesthesia Cesarean delivery Prevention Placebo Intervention group: Capsule of evening primrose oil group: Evening primrose oil capsules are produced by pharmaceutical companies Barij. Providing a capsule in the beginning of the study, if the criteria for entry into the study. Each of the participants in the intervention group given to a bottle containing 14 1000mg oral evening primrose capsules (2 capsules per day, each 12 twelve hours for a week). Control group: Placebo group: The capsules used for the control group are prepared by the researcher that the color and shape of these capsules are similar to the intervention group. Providing a capsule in the beginning of the study, if the criteria for entry into the study. Each of the participants in the control group given to a bottle containing 14 plasbo capsules containing canola oil (2 capsules per day, each 12 twelve hours for a week). Ripening of the cervix. Timepoint: Bishop score is recorded at the beginning of the study and then, if there are no labor symptoms, the Bishop score is measured again after one week. Method of measurement: The second part of the questionnaire:Midwifery Specifications (Bishap Score). Labor progress. Timepoint: Registration of vaginal examinations at the beginning of the study and then in the active phase of the first stage of labor will be done every 2 hours and in the second stage of labor every 30 minutes. The registration of uterine contractions and fetal heart rate at the beginning of the study will be once every 30 minutes in the active phase of the first stage of labor and once every 15 minutes in the second stage of labor. Method of measurement: The third part of the questionnaire (delivery details). Sanandaj University of Medical Sciences Approved 2020-03-15 Ethics Committee of Kurdistan University of Medical Sciences Sanandaj, Pasdaran Street, Kurdistan University of Medical Sciences, School of Nursing and Midwifery Sanandaj Kurdistan Iran (Islamic Republic of)