Preterm Labor
Conditions
Interventions
Place cervical pessary for Women with short cervical length of 25mm or less, who is between 20+0 and 29+6 gestational weeks of pregnancy. Remove cervical pessary until 37+0 gestational weeks or meet
Sponsors
Ozaki Yasuhiko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Pregnant women after 20 weeks gestation, who is disgnosed threatened miscarriage or threatened premature labor. 2)Cervical length of 25mm or less. 3)Women with informed consent for participation in this trial.
Exclusion criteria
Exclusion criteria: 1)Women with multiple pregnant. 2)Majior fetal anomalies. 3)Painful regular uterine contractions. 4)Active vaginal bleeding. 5)Placenta previa. 6)Cervical myoma. 7)History of cone biopsy or cervical cerclage in situ. 8)Other pregnant women when study doctores conclude that they are not eligible for study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delivery less than 34 weeks gestation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Efficacy Delivery less than 37 weeks, Delivery less than 28 weeks, Rupture of membrane less than 34 weeks 2) Maternal background age, gestational weeks at enrollment, pregnancy history, previous medical history, hight, body weight(before pregnancy, at enrollment and delivery), smoking 3) Follow-up during pregnancy gestational weeks at check-up, Cervical length, Funneling, Sludge 4) Safety for mother Chorioamnionitis, Preterm rupture of membranes(PROM), Gestational weeks at PROM, Vaginitis, Increase of vaginal discharge, Way of delivery, Induction of delivery, Bleeding at delivery, Fever at delivery, check for Group B streptococcus, Cervical laceration, Uterus rupture 5) Treatment for mother Gestational weeks at start and stop using cervical pessary, Pessary withdrawal, Hospitalization(duration), Other treatment for threatened preterm labor(Ritodrine hydrochloride, Magnesium Sulfate Hydrate and Hydroxyprogesterone Caproate), Rest at home(duration), Corticosteroid treatment for fetal maturation, Vaginal irrigation 6) Background for baby Gestational weeks at birth, Body weight, Apgar score( 1 min / 5 min after birth), Evaluation of umbilical arterial blood gas(pH, BE) 7) Safety for baby Intrauterine fetal demise, Neonatal demise, Hospitalization at NICU, Adverse outcomes( Intraventricular hemorrhage, Respiratory distress syndrome, Retinopathy, Necrotising enterocolitis, Sepsis, Hyperbilirubinemia and others) 8) Treatment for baby Respiratory treatment, Photo therapy, Antibiotics, Blood transfurion | — |
Contacts
Public ContactKyoko Kumagai
Nagoya City University Hospital
Outcome results
None listed