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A Prospective Multicenter Randomized Controlled Trial Comparing the Impact of Early versus Delayed Rescue Cervical Cerclage on Maternal and Neonatal Outcomes in Singleton Pregnancies.

A Prospective Multicenter Randomized Controlled Trial Comparing the Impact of Early versus Delayed Rescue Cervical Cerclage on Maternal and Neonatal Outcomes in Singleton Pregnancies.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119856
Enrollment
Unknown
Registered
2026-03-04
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

None listed

Interventions

Experimental Group:Early emergency cervical cerclage
Control Group:Delayed emergency cervical cerclage

Sponsors

Fujian Maternity and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Singleton pregnant women in the mid-trimester (gestational age 14+0 to 27+6 weeks). 2. Painless cervical dilation >=1 cm, with or without membrane protrusion. 3. The pregnant woman and her family members are fully informed, voluntarily agree to participate in this study, and have signed the informed consent form. 4. Age >=18 years and <=45 years, with normal cognitive ability.

Exclusion criteria

Exclusion criteria: 1. Presence of contraindications for cervical cerclage: such as preterm premature rupture of membranes (PPROM) before the procedure, active vaginal bleeding, clinically diagnosed chorioamnionitis (body temperature >=38°C, fetal tachycardia, purulent vaginal discharge with elevated white blood cell count), fetus with severe congenital malformations or genetic diseases, or intrauterine fetal death. 2. Candidates for or recipients of Shirodkar cerclage or laparoscopic cerclage. 3. Poor compliance, unable to cooperate with postoperative follow-up. 4. Pregnant women who refuse tocolytic therapy. 5. Iatrogenic preterm birth. 6. Incomplete clinical data. 7. Coexisting severe medical or surgical diseases.

Design outcomes

Primary

MeasureTime frame
Preterm birth rate before 32 weeks;

Secondary

MeasureTime frame
Preterm birth rates at specified gestational ages (<28, <34, <37 weeks);Neonatal survival rate;Neonatal NICU admission rate;Neonatal birth weight (grams);Incidence of maternal complications (PPROM, chorioamnionitis, postpartum hemorrhage, etc.);Incidence of neonatal complications (NEC, IVH, sepsis, RDS, etc.);Prolongation of pregnancy (days);

Countries

China

Contacts

Public ContactMian Pan

Fujian Maternity and Child Health Hospital

panmian1973@126.com+86 591 88312052

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026