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Clinical trial of double and single tranvaginal cervical cligation in the treatment of cervical insufficiency

A prospective randomized, parallel controlled trial comparing the treatment of cervical insufficiency with double and single tranvaginal cervical cligation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058540
Enrollment
Unknown
Registered
2022-04-10
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Preterm birth

Interventions

experimental group:transvaginal two stiches cervical cerclage
control group:transvaginal one stich cervical cerclage

Sponsors

Maternal and Child Health Hospital of Fujian Province
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant patients who received regular birth examination in Fujian Maternal and Child Health Hospital and delivered in our hospital; 2. Single pregnancy; 3. Sign informed consent; 4. Patients with a history of unexplained abortion and premature delivery during pregnancy; 5. Cervical insufficiency confirmed by cervical examination before pregnancy; 6. During the physical examination during pregnancy, painless dilation of the cervix and protrusion of fetal sac at the external cervix were found; 7. In the second trimester, ultrasound found that the length of the cervix was shortened and the inner cervix was dilated; 8. Good follow-up compliance.

Exclusion criteria

Exclusion criteria: 1. Iatrogenic preterm birth factors; 2. Systemic and reproductive tract infections; 3. Fetal chromosome abnormalities or congenital malformations; 4. Fetal growth restriction; 5. Genital tract malformation; 6. Abnormal placenta position; 7. Pregnancy complications: hypertensive diseases during pregnancy, ICP, stillbirth, etc.; 8. Pregnancy complications: obesity, diabetes, hypertension, autoimmune diseases, embolism, digestive diseases, malignant tumors, etc.; History of gastrointestinal surgery.

Design outcomes

Primary

MeasureTime frame
Gestational age at delivery;Live birth rate;

Secondary

MeasureTime frame
Cervical height after cerclage;Prolonged pregnancy period;Fetal weight;Neonatal morbidity;NICU admission rate;

Countries

China

Contacts

Public ContactPan Mian

Fujian Maternal and Child Health Care Hospital Affiliated to Fujian Medical University

panmian1973@126.com+86 13178031273

Outcome results

None listed

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