]>
IRCT20170513033941N39 IRCT 2018-10-21 Kashan University of Medical Sciences Comparison of intravaginal misoprostol, seaweed Laminaria and Foley catheter in pregnant women Comparison of intravaginal misoprostol, seaweed Laminaria and Foley catheter for cervical ripening and induction of labor in term pregnant women 2018-05-29 anticipated 195 Complete https://irct.ir/trial/33983 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease potential confounding effects, all participants will have stratified randomization according to age and other characteristics. Then, participants in each block will be randomly allocated into three intervention groups. Randomization will be done by the use of computer software, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shabihkhani clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants into three groups. 3 Pregnant state. Intervention 1: Intervention group: Intravaginal misoprostol 25 mcg (Cytotec, searle, England) will be put in posterior Culdusac for cervical ripening (n=65). Intervention 2: Intervention group: seaweed Laminaria (Dilateria™, Tasnimbehboud company, Tehran, Iran) will be used for cervical ripening (n=65). Intervention 3: Intervention group: An intra-cervical Foley catheter (size of 22) will be put intra-cervix with sterile condition for cervical ripening and it will be fixed by 15 ml liquid (n=65). 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 Undecided - It is not yet known if there will be a plan to make this available
public Dr. Zohreh Tabassi
Shahid Beheshti Avenue, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 4446 0180 tabasi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Dr. Zohreh Tabassi
Shahid Beheshti Avenue, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 4446 0180 tabasi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Pregnant women aged 18 to 45 years with with unripe cervix Gestational age ≥ 37 ََAmniotic Fluid Index ≥ 5 Bishop Score < 5 18 years 45 years Female Pregnant women with labor pain patients develop chorioamnionitis fever hemorrhage Z33 Pregnant state Treatment - Drugs Treatment - Drugs Treatment - Devices Intervention group: Intravaginal misoprostol 25 mcg (Cytotec, searle, England) will be put in posterior Culdusac for cervical ripening (n=65) Intervention group: seaweed Laminaria (Dilateria™, Tasnimbehboud company, Tehran, Iran) will be used for cervical ripening (n=65) Intervention group: An intra-cervical Foley catheter (size of 22) will be put intra-cervix with sterile condition for cervical ripening and it will be fixed by 15 ml liquid (n=65) Bishop Scores. Timepoint: six hours after the intervention. Method of measurement: Physical Examination. Cervical dilatation. Timepoint: six hours after the intervention. Method of measurement: Physical Examination. Induction time to active phase of labor. Timepoint: after the intervention. Method of measurement: time measrement (hours). Induction time to delivery time. Timepoint: after the intervention. Method of measurement: time measrement (hours). Cesarean frequency rate. Timepoint: after the intervention. Method of measurement: checklist. Intrapartum complications (Placental Abruption, atonia, and etc). Timepoint: after the intervention. Method of measurement: physical examination. Kashan University of Medical Sciences Approved 2018-05-28 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)