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IRCT20180819040830N3 IRCT 2020-04-29 Shahid Beheshti University of Medical Sciences Role of Cervical Pessary in Prevention of Preterm Labor - Comparison of Efficacy and Safety of Cervical Pessary with Routine Management in Decreasing the Preterm Labor Rate in Nulliparous Symptomatic Pregnant Women with Short Cervix: A Randomized Clinical Trial 2020-05-01 anticipated 100 Complete https://irct.ir/trial/45855 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: --, Randomization description: Computer generated blocks of 4 in block randomization method. N/A preterm labor. Intervention 1: Intervention group: insertion of a cervical pessary (Milex® Pessary, CooperSurgical co, NewYork, USA) with proper size. Intervention 2: Control group: routin care. No - There is not a plan to make this available Justification or reason for not sharing IPD is "There is no further information"
public Zahra Naeiji
Shishe gar Khaneh St., Fadayian Eslam blv., Shossh Sq.
Tehran Iran (Islamic Republic of) 1445663693 +98 21 5506 2628 zahranaeiji1398@yahoo.com Shahid Beheshti University of Medical Sciences scientific Zahra Naeiji
Mahdiye hospital, Shishegar Khaaneh St., Fadayian Eslam Blv.
Tehran Iran (Islamic Republic of) 1445763693 +98 21 5506 2628 zahrabahman77@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Gestational age between 24 weeks and 0 days to 34 weeks and 0 days Shortened cervical length (defined as cervical length ≤25 mm measured by trans-vaginal ultrasound scan in second trimester) 18 years no limit Female Major fetal abnormalities Fever or any other clinical findings in favor of chorioamnionitis and Placenta previa Women with normal cervical length Women who had not responded to the routine standard treatments of preterm labor and were experiencing continued signs and symptoms of preterm labor after 48 hours of admission Vaginal bleeding Signs of ruptured membranes. Treatment - Devices Treatment - Devices Intervention group: insertion of a cervical pessary (Milex® Pessary, CooperSurgical co, NewYork, USA) with proper size Control group: routin care Giving birth after 37 weeks of gestation. Timepoint: At delivery time. Method of measurement: Number of weeks and days between first day of the last menstrual period and day of delivery. Possible side effects of pessary (including vaginal discharge, pessary descent, urinary tract infection, severe pelvic pain or discomfort). Timepoint: From pessary insertion to delivery. Method of measurement: history taking and physical examination. Delivery before 34 weeks of gestation. Timepoint: At labor. Method of measurement: Number of weeks and days between first day of last menstrual period and day of delivery. Shahid Beheshti University of Medical Sciences Approved 2017-09-21 Ethics committee, Shahid Beheshti University of Medical Sciences Mahdiye hospital, Shishegar Khaaneh St., Fadayian Eslam Blv. Tehran Tehran Iran (Islamic Republic of)