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IRCT20180819040830N1 IRCT 2018-11-24 Shahid Beheshti University of Medical Sciences Evaluation of the effect of oral hyoscine on the rate of cervical opening in term pregnancy Evaluation of the effect of oral hyoscine on cervix status (Bishop score) in term pregnancy 2017-09-23 anticipated 100 Complete https://irct.ir/trial/34250 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A 10-by-10 table, which is randomly generated by the computer and contains numbers from 1 to 100, is used. Selecting a sample starts at the first cell from top and left of the table and goes left to right and up to down. Odds numbers are assigned to the control group and even numbers are assigned to the Hyoscine group. 3 Pregnancy. Intervention 1: Intervention group: taking oral hyoscine 10 mg twice daily for one week and then once a day in the second week since entering the study (39-40 weeks). Intervention 2: Control group: Expected Treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is No need for publication
public Zahra Naeiji
Shush squar,Tehran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 z.naeigi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Zahra Naeiji
Shush squar,Tehran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 z.naeigi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age older than 18 years Primiparous Gestational age of 39 weeks and 0 days to 40 weeks and 0 days Spontaneous pregnancy Singleton pregnancy Cephalic presentation Bishop score equal to or less than 5 18 years no limit Female The existence of a placenta previa or placenta detachment (decollement) Fetal distress The presence of IUGR or macrosomal infant (embryo weighing more than 4000 gr) The presence of underlying illness, such as diabetes or pre-pregnancy or pre-pregnancy hypertension History of cervix trauma Hyoscine susceptibility History of cervical or uterine surgery Using narcotic drugs or analgesics The presence of glaucoma The presence of cardiovascular disease or tachycardia more than 100 beats per minute Treatment - Drugs Other Intervention group: taking oral hyoscine 10 mg twice daily for one week and then once a day in the second week since entering the study (39-40 weeks) Control group: Expected Treatment Cervix status. Timepoint: At the time of entering the design, 24 hours later, and then every 72 hours until delivery and at the time of delivery. Method of measurement: The Bishop Score gives points to 5 measurements of the pelvic examination dilation, effacement of the cervix, station of the fetus, consistency of the cervix, and position of the cervix and its rage is 0 to 13. Gestational age at delivery time. Timepoint: At delivery time. Method of measurement: Ask the patient. Delivery type. Timepoint: At delivery. Method of measurement: Normal vaginal delivery (NVD), Cesarean section (C/S). Shahid Beheshti University of Medical Sciences Approved 2018-09-02 Ethics committee of Shahid Beheshti University of Medical Sciences Next to Taleghani hospital, Shahid Arabi Ave, Yemen St., Chamran highway Tehran Tehran Iran (Islamic Republic of)