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Preconceptional transvaginal cervicoisthmic cerclage versus transvaginal cervicoisthmic cerclage in pregnancy for the prevention of preterm delivery in women with cervical insufficiency

Preconceptional transvaginal cervicoisthmic cerclage versus transvaginal cervicoisthmic cerclage in pregnancy for the prevention of preterm delivery in women with cervical insufficiency: a randomized controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13763635
Enrollment
200
Registered
2015-01-14
Start date
2015-01-01
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Cervical insufficiency Pregnancy and Childbirth

Interventions

The modified transvaginal cervicoisthmic cerclage was performed by the same surgeon, assisted with one or two physicians. The preconceptional cerclage was performed with general anesthesia, and the ce

Sponsors

Health Bureau of Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 04/03/2019: 1. A history of at least 1 previous late inevitable abortion or spontaneous preterm delivery 2. Previous conization of the cervix or cervical laceration by assisted vaginal delivery, and the residual cervix is less than 25mm 3. All patients should be >=18 years and younger than 35 years old 4. All patients are able to conceive Previous inclusion criteria: 1. A history of at least 2 previous late inevitable abortion or spontaneous preterm delivery 2. Previous conization of the cervix or cervical laceration by assisted vaginal delivery, and the residual cervix is less than 25mm 3. All patients should be >=18 years and younger than 35 years old 4. All patients are able to conceive

Exclusion criteria

Exclusion criteria: 1. Older than 35 years old 2. Patients with a successful or failed cerclage applied in a previous pregnancy 3. Patients with congenital uterine dysplasia: Mediastinum uterus, bicornuate uterus, rudimentary horn of uterus, et al. 4. Patients with protein C, protein S, or antithrombin III de?ciency 5. Patients who are pregnant

Design outcomes

Primary

MeasureTime frame
1. The perinatal survival rate 2. The delivery gestational age

Secondary

MeasureTime frame
1. Complications during pregnancy 2. The fetal weight

Countries

China

Outcome results

None listed

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