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IRCT20200118046180N1 IRCT 2020-07-23 Tehran University of Medical Sciences effect of evening primrose oil on cervical ripening Comparing effect of oral and vaginal evening primrose oil on cervical ripening in pregnant women 2020-02-04 anticipated 120 Complete https://irct.ir/trial/45239 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be conducted in the form of Block Randomization. The first intervention group will be marked with the letter A, the second intervention group will be marked with the letter B, and the control group will be marked with the letter C. In the next step, six similar cards will be prepared and on each card, different rows of ABC letters (ABC, ACB, BCA,...) will be written, Each time a card is randomly selected, and after noting the order, it will be added again to the other cards. This process will continue until the sample size is completed. 3 Cervical ripening. Intervention 1: First intervention group: In the first group, a bottle containing 1000 mg of evening primrose oil capsule made by Barij Essence Company will be given to mothers to use vaginally every week for 12 weeks from 39 weeks of pregnancy and then until the onset of labor pains once a day. If labor pains do not start or there are few contractions at the time of hospitalization, 10 oxytocin units will be induced. Intervention 2: second intervention group: In the second group, a bottle containing 1000 mg of evening primrose oil capsule made by Barij Essence Company will be given to mothers to use orally every week for 12 weeks from 39 weeks of pregnancy and then until the onset of labor pains once a day. If labor pains do not start or there are few contractions at the time of hospitalization, 10 oxytocin units will be induced. Intervention 3: Control group: In this group, no action will be taken before hospitalization for delivery, in case of non-onset of labor pains or low contractions of labor delivery, 10 units of oxytocin will be administered. 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 No more information
public Parisa Heydari
No.15, Shahid Tafakori Ave. Shohada Town
Bafgh Iran (Islamic Republic of) 8971717479 +98 35 3242 6594 parisa.heydary@yahoo.com Tehran University of Medical Sciences scientific Parisa Heydari
No.15, Shahid tafakori Ave. Shohada Town
Bafgh Iran (Islamic Republic of) 8971717479 +98 35 3242 6594 parisa.heydary@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Primiparous and low-risk pregnant women Gestational age 39 weeks Cephalic presentation bishop score of 4 or less Single pregnancy 18 years 35 years Female A history of uterine surgery Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group: In the first group, a bottle containing 1000 mg of evening primrose oil capsule made by Barij Essence Company will be given to mothers to use vaginally every week for 12 weeks from 39 weeks of pregnancy and then until the onset of labor pains once a day. If labor pains do not start or there are few contractions at the time of hospitalization, 10 oxytocin units will be induced. second intervention group: In the second group, a bottle containing 1000 mg of evening primrose oil capsule made by Barij Essence Company will be given to mothers to use orally every week for 12 weeks from 39 weeks of pregnancy and then until the onset of labor pains once a day. If labor pains do not start or there are few contractions at the time of hospitalization, 10 oxytocin units will be induced. Control group: In this group, no action will be taken before hospitalization for delivery, in case of non-onset of labor pains or low contractions of labor delivery, 10 units of oxytocin will be administered. Cervical Preparation. Timepoint: Before the intervention and at the time of hospitalization for delivery. Method of measurement: Bishop's score measurement. Duration of hospitalization to delivery. Timepoint: Duration of hospitalization to delivery. Method of measurement: questionnaire. Newborn Agar score. Timepoint: The first minute and Fifth minutes after birth. Method of measurement: questionnaire. Type of delivery. Timepoint: End of intervention. Method of measurement: questionnaire. Need to induction. Timepoint: hospitalization until delivery. Method of measurement: questionnaire. Tehran University of Medical Sciences Approved 2019-10-15 Ethics committee of Tehran University of Medical Sciences No.15, Shahid Tafakori Ave. Shohada Town Bafq Yazd Iran (Islamic Republic of)