SPIRAL trial

JRCT ID: jRCT1062200001

Registered date:01/05/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Selective Ceasearian section
• Date of first enrollment: 01/05/2020
• Target sample size: 260
• Study type: Interventional
• Intervention(s): 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 standardized at all facilities. After the principal investigator goes to each facility and practices the procedure in advance, a procedure manual is created and the procedure is unified at each medical institution. Sutures may not be used for longer than 6 weeks and may not be used in areas where sutures need to be spliced or where long fusion times are required, such as fascia. The uterus does not fall in that location.

Outcome(s)

Primary Outcome

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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include 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.

Exclude 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)

Related Information

• Primary Sponsor: Maki Jota