Preterm delivery. Preterm spontaneous labour with preterm delivery
Conditions
Interventions
Intervention 1: Intervention Group:
Cervical pessary inserted by an obstetrician, between 18-20 weeks of gestation, in an outpatient setting.A vaginal speculum examination was done to determine the ap
Treatment - Devices
Treatment - Drugs
Intervention Group:
Cervical pessary inserted by an obstetrician, between 18-20 weeks of gestation, in an outpatient setting.A vaginal speculum examination was done to determine the appropriate size.
Control Group:
Patients received 400 mg of vaginal progesterone once daily before going to bed until 37th week of gestation.
Sponsors
Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 18-40 years of age; singleton gestation; 18-22 gestational weeks; cervical length of less than 25 millimeters by transvaginal ultrasound; no cervical dilation; no history of any medical illness. Exclusion criteria: : any medical illness upon enrollment; having urogenital infection; major fetal abnormalities; painful regular uterine contractions; placenta previa; ruptured membranes; active vaginal bleeding; history of cone biopsy; refusing to provide informed consent to participate in the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preterm birth before 37 weeks of gestation. Timepoint: monthly, after the intervention, untill 37th week of gestational. Method of measurement: clinical delivery and the time is assessed based on ultrasound imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Low birth weight (LBW) delivery. Timepoint: After birth. Method of measurement: weighing scale.;Premature rupture of membranes. Timepoint: after the intervention. Method of measurement: clinical examination.;Chorioamnionitis. Timepoint: after the intervention. Method of measurement: diagnosed based on placental pathology after delivery.;Requirement for NICU admission. Timepoint: after the intervention. Method of measurement: clinical examination.;Fetal or neonatal death rate. Timepoint: after the intervention. Method of measurement: clinical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNiloofar Karbasian
Tehran University of Medical Scienses
Outcome results
None listed