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Safety and efficacy evaluation of laparoscopic abdominal cerclage in patients with cervical insufficiency

Safety and efficacy evaluation of laparoscopic abdominal cerclage in patients with cervical insufficiency

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042210069
Enrollment
32
Registered
2021-09-13
Start date
2021-09-13
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

cervical insufficiency

Interventions

laparoscopic transabdominal cervical cerclarge

Sponsors

Ikeda Tomoaki
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Cervical insufficiency and its high-risk cases between 16 and 50 years old females 1) Patients who underwent transvaginal cervical cerclarge but suffered a premature miscarriage 2) Cases with a shortened cervix that is anatomically difficult to treat with transvaginal cervical cerclarge 3) Cases deemed necessary by the principal investigator and sub-investigators

Exclusion criteria

Exclusion criteria: 1) Cases with suspected intrauterine infection 2) Patients who are expected to have difficulty in surgery due to enlargement of the uterus caused by pregnancy 3) Patients with serious complications that may interfere with general anesthesia or insufflation 4) Patients who do not wish to have a baby 5) Patients who are pregnant and do not wish to continue the pregnancy 6) Cases of intrauterine fetal death 7) Cases of concomitant malignancy 8) Cases in which participation in the research is judged to be difficult by the principal investigator or sub-investigator

Design outcomes

Primary

MeasureTime frame
Survival rate of newborn children discharged from hospital

Secondary

MeasureTime frame
Production rate after 34 weeks gestation, prolonged weeks gestation, second trimester miscarriage rate, intraoperative and early postoperative complications (frequency of complications within 2 weeks and operative time and blood loss), postoperative quality of life (EQ-5D-5L)

Contacts

Public ContactMasafumi Nii

Mie Univercity Hospital

m-nii1984@med.mie-u.ac.jp+81-9073141064

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026