Preterm Birth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Pregnant women were 18 years old <= age <= 45 years old; 2.Singleton pregnancies with gestational age < 13 weeks and planned delivery at our center; 3.Cervical cerclage was performed based on ultrasound indications at 14+ 0-23 +6 weeks of gestation; 4.After the cerclage, follow-up showed that the amniotic sac was convex before 27 weeks of gestation; 5.Subjects were fully informed about the study process and signed an informed consent form; 6.Participants could follow up as planned.
Exclusion criteria
Exclusion criteria: 1.Twin or multiple births; 2.Severe medical and surgical diseases (including cancer, liver disease, kidney disease, immune diseases, etc.); 3.Fetal malformation was found during pregnancy; 4.Selective fetal reduction was performed during pregnancy; 5.Severely Infected patients; 6.There are other surgical/treatment plans that may affect the compliance of the subjects to this study; 7.The subjects were enrolled in other clinical studies and had not yet reached the study endpoint; 8.It was known that the intended study follow-up could not be completed for any reason; 9.Informed consent was refused.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of spontaneous preterm birth less than 34 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Pregnancy ;Length of Stay in the NICU;NICU Admission Rate;Newborn birth weight;Gestational age at delivery;Incidence of premature rupture of membranes;Incidence of preterm birth at other gestational weeks: at 26,28,30,32, 36, and 37 weeks;Neonatal COMPOSITE OUTCOME;Incidence of cervical laceration; | — |
Countries
China
Contacts
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine