preterm labor.
Conditions
Interventions
Intervention 1: Intervention group: insertion of a cervical pessary (Milex® Pessary, CooperSurgical co, NewYork, USA) with proper size. Intervention 2: Control group: routin care.
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Naeiji
Shahid Beheshti University of Medical Sciences
Outcome results
None listed