Cervical pessary for the prevention of preterm delivery in pregnant women with a short cervix.
Not Applicable
- Conditions
- preterm delivery
- Registration Number
- JPRN-UMIN000015465
- Lead Sponsor
- agoya City University Medical School, Department of obstetrics and gynecology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 3
Inclusion Criteria
Not provided
Exclusion Criteria
1) Women with multiple pregnant 2) Cervical length id more than 26mm 3) Major fetal anomalies 4) Painful regular uterine contractions 5) Active vaginal bleeding 6) Ruptured membranes 7) Placenta previa 8) Cervical myoma 9) History of cone biopsy or cervical cerclage in situ 10) Other pregnant women when study doctors conclude that they are not eligible for study enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of term delivery is equal or higher compare to the conventional therapy for prevention of preterm delivery.
- Secondary Outcome Measures
Name Time Method A) Pregnancy outcome 1. Spontaneous delivery before 28 weeks 2. Spontaneous delivery before 37 weeks 3. Gestational age at delivery 4. Tocolytic treatment 5. Premature preterm rupture of membranes 6. Corticosteroid treatment for fetal maturation 7. Chorioamnionitis 8. Hospitalization 9. Vaginal discharge 10. Pessary withdrawal 11. Bleeding at delivery 12. Cervical laceration 13. Uterus rupture B) Perinatal outcome 1. Fetal death 2. Neonatal death 3. Birth weight 4. Adverse outcomes (Intraventricular hemorrhage, Respiratory distress syndrome, Retinopathy, Necrotising enterocolitis, Sepsis) 5. Hospitalization at NIC