cervical incompetence
Conditions
Interventions
Laparoscopic Cervico-isthmic Cerclage: LCIC
Sponsors
The department of obstetrics and gynecology, Showa University Northern Yokohama Hospital
Department of Obstetrics and Gynecology Showa University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)A pregnant patient with cervical incompetency. The clinical conditions listed below are the specific targets identified: 1.Patients with loss of the uterine cervix after uterine conization 2.Women with uterine cervix cleavage 3.Women with vaginal deformation due to laceration of the cervix 4.Women who had a premature delivery despite having undergone transvaginal cervical cerclage in the past 5.Women with cervical incompetency occurring in the first and/or second trimesters of pregnancy 6.Women with a history of premature delivery at a gestational age of <34 weeks or shortening of the cervical length (<25 mm) confirmed on transvaginal ultrasonography in the early pregnancy period. 7.A patient judged by the medical officer responsible for performing the treatment and the attending physician as requiring such treatment 2)A patient who is at least 16 years old but <55 years old at the time of giving her consent. 3)A patient who personally gives her written informed consent to participate in this study. In the event that the age of the patient is <20 years, a written informed consent must be obtained from the legally acceptable representative of the patient. 4)A patient who is eligible for this study is confirmed by several specialists and will be selected carefully once the safety of the patient is ensured.
Exclusion criteria
Exclusion criteria: 1) A pregnant woman for whom LCIC is judged to be impossible to perform because of intense intra-abdominal adhesion 2) A pregnant woman with intrauterine fetal death prior to LCIC 3) A pregnant woman judged to be in a state with a high possibility of the fetus aborting before LCIC 4) A pregnant woman with a coexisting malignant tumor 5) A pregnant woman judged by the principal investigator as not eligible to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prolonging pregnancy: especially prolonging pregnancy after 34 weeks of gestational age | — |
Secondary
| Measure | Time frame |
|---|---|
| Neonatal prognosis and neonatal information. For example, height, weight, Apgar score etc. | — |
Countries
Japan
Contacts
Public ContactKohei Seo
Showa University Northern Yokohama Hospital The department of obstetrics and gynecology
Outcome results
None listed