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SPIRAL trial

Assesment of prevention with Spiral to the complications associated with cesarean section wounds -Randomized controlled trial with conventional suture thread- - Prevention of caesarean section scar syndrome using spiral thread

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1062200001
Enrollment
260
Registered
2020-05-01
Start date
2020-05-07
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

Selective Ceasearian section The presence of a cesarean scar defect and diverticulum, Selective Ceasearian section

Interventions

Transect the lower uterus about 10cm, and perform uterine suture using two vicrye threads or two spiral plus thread at the timing of uterine repair after delivery. Surgical procedures should be standa
D011248
The presence of a cesarean scar defect and diverticulum, Selective Ceasearian section

Sponsors

Maki Jota
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Compare the degree of thinning of the scar. The most important evaluation things are transvaginal ultrasonography 6-7 months after surgery, and the position of the uterus (forward or backward) and the thickness of the myometrial wound in the following 1 to 4 were measured and analyzed It. The evaluation of the degree of thinning is based on four measurements of the transvaginal ultrasonic sagittal slice and the thinned portion of the cross section 1 Head-to-caudal distance 2 Depth of recess 3 Thymus layer thickness left on the serosa from the most depressed recess 4 Left and right width of recess. The percentage of the remaining myometrium thickness 3 is calculated from the total myometrium thickness 2 and 3 , and the thinning rate is recorded. In addition, 1-4 will be compared between the two groups.

Secondary

MeasureTime frame
1 Comparison of operation time and required time (time from delivery to completion of uterine suture), bleeding, number of additional Z sutures to stop bleeding in addition to continuous suture, complications during surgery, postoperative infection,years of experience of surgeons 2 Child: Age, sex, birth weight, height, umbilical cord blood gas analysis (pH), infant umbilical cord blood test: PO2, PCO2, BE, HCO3-, glucose level, lactate, presence of newborn abnormality 3 Maternal: Age, maternal complications, number of weeks of delivery, opening of uterine ostium (cm), degree of spread (%) physique, BMI, weight gain, treatment content and perinatal period, 1 month postoperative examination Presence or absence of blood retention, the incidence of abnormalities during the treatment and perinatal period were as follows: at discharge, 1 month and 3 months after surgery, transvaginal ultrasonography, hematoma in front of the uterine wound (hematoma) The presence or absence of hematoma is judged to be hematoma if a hematoma is indicated by transluminal ultrasonography.) The incidence of postoperative fever (postoperative fever is a cause of Patients treated with antibiotics other than clinical path as suspected intraperitoneal infection are judged to have fever), presence of dysmenorrhea at 6 or 7 months, presence of chronic pelvic pain (confirmed by interview) 4 Safety ,presence or absence of serious adverse events.

Contacts

Public ContactJota Maki

Okayama University Hospital

jotajjjo@gmail.com+81-86-235-7320

Outcome results

None listed

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