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IRCT20201115049389N1 IRCT 2021-01-16 Mashhad University of Medical Sciences Comparison of the effect of vaginal consumption of primrose oil on the preparation of cervix in term delivery at patient resort to educational hospitals of Medical Sciences Comparison of the effect of vaginal consumption of primrose oil on the preparation of cervix in term delivery at patient resort to educational hospitals of Medical Sciences 2020-11-09 anticipated 76 Complete https://irct.ir/trial/52326 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: 529 / 5000Translation resultsWe use the Bishop score to check the degree of softening of the cervix. We randomly divide the referring women into two groups, A and B, after completing the informed consent form. We measure demographic information, gestational age, bishop score, last period date, induction delivery interval, mode of delivery, 3rd stage blood loss, and fetomaternal outcome. In both groups, strip is done and one group of primrose oil is blinded on one side. We measure Bishop score, duration of labor, and postpartum hemorrhage, Apgar score 1 and 5 minutes, Randomization description: Since the two groups are supposed to have the same sample size, Patients eligible for inclusion will be divided into 2 groups using the Blocked Randomization method by one of the nurses of the relevant ward, who is not aware of the implementation of the study. Random sequences will be generated using the Random Generator program. Random allocation concealment will be done using sequentially numbered, sealed, opaque envelopes by an independent person who does not know the study process. 0 (exploratory trials) Pregnant mothers. Intervention 1: Intervention group: Evening primrose oil capsules will receive up to 6 doses vaginally every 4 to 6 hours a day. Intervention 2: Control group: They are just examined. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Marzieh Lotfalizadeh
Imam Reza hospital. Imam Reza square.
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3854 3031 lotfalizade@mums.ac.ir Mashhad University of Medical Sciences scientific Mahya Labbafchi
Imam Reza hospital. Imam Reza square.
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3854 3031 LabbafchiM961@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Low risk of pregnancy Bishop score less than 4 BMI between 19 and 25 Lack of systemic disease No drug addiction No vaginal bleeding Gain conscious satisfaction no limit no limit Female Patient non-cooperation Increased risks of delivery Use other methods of uterine preparation Diabetes and hypertension Chronic inflammatory disease Improper fetal presentation P03.8 Newborn (suspected to be) affected by other specified complications of labor and delivery Treatment - Drugs Treatment - Drugs Intervention group: Evening primrose oil capsules will receive up to 6 doses vaginally every 4 to 6 hours a day. Control group: They are just examined. Bishop score measured. Timepoint: Before interventional and 24 hours after intervention. Method of measurement: questionnaire. Mashhad University of Medical Sciences Approved 2020-11-09 Ethics committee of Mashhad University of Medical Sciences Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square Mashhad Razavi Khorasan Iran (Islamic Republic of)