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Double cerclage versus single cerclage in pregnant women with cervical dysfunction: a multicentre, randomized controlled trial

Double cerclage versus single cerclage in pregnant women with cervical dysfunction: a multicentre, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049822
Enrollment
Unknown
Registered
2021-08-10
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Pregnancy with cervical insufficiency

Interventions

Group 2:Single cervix clasp
Group 1:Double cervix clasp

Sponsors

Lanzhou University Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 40 years; 2. Pregnant women who meet the diagnostic criteria for cervical insufficiency: 3. Diagnosis based on medical history It is currently believed that even if it is 1 or 2 times of painless cervical dilation in the third trimester of pregnancy, followed by no uterine contractions in the second trimester, labor signs and bleeding, infection, membrane rupture and other clear pathological factors, pregnancy products are discharged. The typical medical history can be diagnosed; 4. Diagnosis based on ultrasound markers such as cervical length and cervical shortening in the second trimester. The critical value of cervical length is 25 mm, and cervical insufficiency is considered when the cervical length is less than 25 mm; 5. Trial diagnosis in non-pregnant period Including hysterosalpingography (HSG), luteal phase with cervical dilator 7 to assess cervical dilation method. 6. Pregnant women who have undergone transvaginal cervical cerclage; 7. Willingness to participate in this research.

Exclusion criteria

Exclusion criteria: 1. Fetal abnormalities; 2. Clinically significant maternal-fetal complications (such as fetal red blood cell alloimmunity, chronic hypertension, insulin-dependent diabetes mellitus, placenta previa, placental abruption); 3. Ultrasound and hysteroscopy found abnormal uterine structure (such as uterine malformation, uterine fibroids, etc.); 4. Unexplained vaginal bleeding; 5. Combined with the following diseases and the symptoms have not been controlled: asthma, type II diabetes, serious infection; 6. History of cervical cerclage in the past; 7. Patients with voluntary termination of pregnancy or medically directed delivery due to preeclampsia, intrauterine fetal death and/or uncertain fetal status before 35 weeks of gestation; 8. Refuse to participate in this researcher.

Design outcomes

Secondary

MeasureTime frame
Abortion;Incidence of obstetric complications;Birth weight;neonatal survival rate;Apgar scores at birth;The operation time;Average length of stay;Length of the cervix before and after suture;

Primary

MeasureTime frame
The rate is less than 34 weeks;

Countries

China

Contacts

Public ContactWang Fang

Lanzhou University Second Hospital

ery_fwang@lzu.edu.cn+86 13919302888

Outcome results

None listed

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