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IRCT138903121096N3 IRCT 2010-06-02 Vice chancellor for research -Guilan university of medical sciences Effect of sublingual Misoprostol versus vaginal Misoprostol in labor induction success. Comparison of Sublingual and vaginal Misoprostol for labor induction in primiparous women 2010-07-23 anticipated 126 Complete https://irct.ir/trial/118 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 labour induction. Intervention 1: Prescription of 25 microgram of sublingual Misoprostol plus vaginal placebo every four hours up to four times. Intervention 2: Prescription of 50 microgram of vaginal Misoprostol plus sublingual placebo every four hours up to four times.
public Dr.Seyede Hajar Sharami
Reproductive Health Research center , Department of Ob &Gyn, Alzahra Hospital, Guilan university of Medical Sciences , Namjo street
Rasht Iran (Islamic Republic of) +98 911 131 3242 Sharami@gums.ac.ir Guilan university of medical sciences scientific Dr.seyede Hajar Sharami
Reproductive Health Research center , Department of Ob &Gyn, Alzahra Hospital, Guilan university of Medical Sciences , Namjo street
Rasht Iran (Islamic Republic of) +98 13 1322 5624 sharami@gums.ac.ir Guilan University of Medical Scienes Iran (Islamic Republic of) Inclusion criteria: a) single pregnancy (between 36 to 42 weeks), b) vertex presentation, c) intact fetal membrane, d) bishop score equal or less than four e) absence of uterus spontaneous contractions f) fetal weight less than 4000gr j) normal fetal heart rate h) cephalopelvic proportion Exclusion criteria: a) sensitivity to PGs b) previous history of cesarean c) uterus wall scar d) preeclampsia or blood pressure more than 140/90 mmhg e) PROM f) vaginal bleeding 15 years 45 years Female O62.3 Precipitate labour Treatment - Drugs Treatment - Drugs Prescription of 25 microgram of sublingual Misoprostol plus vaginal placebo every four hours up to four times. Prescription of 50 microgram of vaginal Misoprostol plus sublingual placebo every four hours up to four times. Time interval from labour induction to delivery. Timepoint: After delivery. Method of measurement: Time recording of induction beginning and delivery in Questionnaire. Delivery type frequency. Timepoint: After delivery. Method of measurement: patient medical document. Dose amount. Timepoint: Four hours after last prescription of Misoprostol up to delivery time. Method of measurement: Patient medical document. Vaginal delivery frequency during first 12 hours. Timepoint: During 12 hours from induction beginning. Method of measurement: Patient medical document. Vaginal delivery frequency during first 12 to 24 hours. Timepoint: During 12 to 24 hours from induction beginning. Method of measurement: Patient medical document. Tachysystole incidence rate. Timepoint: Every 4 hours until entering in active phase. Method of measurement: Fetal heart monitoring device and recording of uterus contractions. Hyper stimulation incidence rate. Timepoint: Every 4 hours until entering in active phase. Method of measurement: Fetal heart monitoring device and recording of uterus contractions. Cesarean rate due to FHR disorder. Timepoint: After cesarean. Method of measurement: patient medical document. Cesarean section rate due to delivery failure. Timepoint: After cesarean section. Method of measurement: Patient medical document. Apgar score below 7 rate. Timepoint: After delivery. Method of measurement: Patient medical document. Meconium discharge rate. Timepoint: By presenting 3cm or more dilatation after rupture of membrance. Method of measurement: Clinical examination or patient medical document. NICU admission rate. Timepoint: After delivery. Method of measurement: Patient medical document. Bishop score alteration average after 4 hours. Timepoint: After 4 hours from beginning of induction. Method of measurement: Vaginal examination. Vice chancellor for research -Guilan university of medical sciences Approved Vice Chancellor for research , Guilan university of medical sciences Namjoo street, Vice Chancellor for research , Guilan university of medical sciences Rasht Iran (Islamic Republic of)