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Value of cervical cerclage after ultrasound indication in preventing preterm birth in singleton pregnancies: a multi-center pragmatic randomized controlled trial

Value of cervical cerclage after ultrasound indication in preventing preterm birth in singleton pregnancies: a multi-center pragmatic randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108152
Enrollment
Unknown
Registered
2025-08-26
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Interventions

Control group:Tocolysis + reduced activity
Experimental Group:Cervical cerclage was performed again

Sponsors

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

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

MeasureTime frame
Incidence of spontaneous preterm birth less than 34 weeks;

Secondary

MeasureTime 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

Public ContactHao Ying

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

stephenying_2011@163.com+86 21 20261211

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026