SPIRAL trial

Phase 1

• Conditions: Selective Ceasearian section; D011248; The presence of a cesarean scar defect and diverticulum, Selective Ceasearian section

• Registration Number: JPRN-jRCT1062200001
• Lead Sponsor: Maki Jota

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

For those that meet all the following criteria.
(1) A person who is 20 years of age or older when obtaining consent.
(2) The person that a document agreement was provided after enough understanding and have been received enough explanation on participating of this study.
(3) Patients who are scheduled to undergo selective cesarean section who are hospitalized or admitted to a research institution including Okayama University Hospital Obstetrics and Gynecology on March 31, 2022 after approval of jRCT. An initial cesarean section is a patient who undergoes a cesarean section for the first time because of a breech (pelvic position), fetal bad condition, maternal bad condition,prolonged delivery.
(4) Person who can approve that the researcher obtains information on the infant from the medical record.

Exclusion Criteria

For those that meet one of the following exclusion criteria.
1 She is a changing hospital planned patient on the way
2 Patient of the following pregnancy
A case to Patients with the following combined pregnancy, to pregnancy with blood disorders,
to pregnancy with coagulopathy, to multiple pregnancy,
to mental illness complications,
to incision other than lower uterine transection,
to pre-placental case,
to postpartum hemoreage (bleeding more than 2000ml),
to emergency cesarean section after full opening of the uterine ostium,
to anterior adenomyosis of the anterior wall,
to have myoma within the incision.
3 Patients who are hypersensitive to constituent metals such as stainless steel or chromium and nickel or triclo-asid.
4 In addition, Patients who were judged by the investigator to be inappropriate as study subjects (understood poor understanding / objection of study)

Study & Design

• Study Type: Interventional
• Study Design: Not specified