NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1042210069

Registered date:13/09/2021

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

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedcervical insufficiency
Date of first enrollment13/09/2021
Target sample size32
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)laparoscopic transabdominal cervical cerclarge

Outcome(s)

Primary OutcomeSurvival rate of newborn children discharged from hospital
Secondary OutcomeProduction 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
GenderFemale
Include criteriaCervical 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 criteria1) 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

Contact

Public contact
Name Masafumi Nii
Address 2-174,Edobashi, Tsu, Mie Mie Japan 514-8507
Telephone +81-9073141064
E-mail m-nii1984@med.mie-u.ac.jp
Affiliation Mie Univercity Hospital
Scientific contact
Name Tomoaki Ikeda
Address 2-174,Edobashi, Tsu, Mie Mie Japan 514-8507
Telephone +81-592321111
E-mail t-ikeda@clin.medic.mie-u.ac.jp
Affiliation Mie Univercity Hospital