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

JRCT ID: jRCT1042210069

Registered date:13/09/2021

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: cervical insufficiency
• Date of first enrollment: 13/09/2021
• Target sample size: 32
• Study type: Interventional
• Intervention(s): laparoscopic transabdominal cervical cerclarge

Outcome(s)

• Primary Outcome: Survival rate of newborn children discharged from hospital
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 50age old
• Gender: Female

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ikeda Tomoaki