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临床试验/NCT04891042
NCT04891042Unknown不适用

The Importance of Isthmocele Development Due to Primary Cesarean Section at The Latent or Active Phase of Labour

Zeynep Kamil Maternity and Pediatric Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
320
试验地点
1
主要终点
Isthmocele Development

研究概览

简要总结

The importance of isthmocele development due to primary cesarean section at the latent or active phase of labour

详细描述

The dates between February 2021 to December 2021 , primiparous (primigravida) and multiparous (multigravida) patients who were hospitalized for delivery between 32 and 41 weeks of gestation and who haven't received cesarean in their previous delivery will be included in the study in Zeynep Kamil Training and Research Hospital Hynecology and Obstetrics Clinic. These patients who will have indication for primary cesarean section will be divided into two groups as latent and active phase according to cervical opening and effacement.During cesarean section , tue uterine lower segment transverse incision will be continuously sutured with 1.0 vicryl( with no interlocking). Also the visceral peritoneum of the vesicle-uterine cavity will be sutured with 2.0 vicryl, This closure technique is to provide hemostasis in the incision. Also additional single interrupted sutures will be recorded(on the each side and /or in the middle of incision).Also If additional surgical interventions such as vessel ligation, uterine artery compression sutures ( such as B-Lynch) will be performed during the surgery, the will be recorded.In this study, If the patients with gestational age below 32, confirmed placenta previa or invasion anomaly and a history of previous cesarean section will not be included.All patient's age, gravid , parity, height, weight, gestational week, smoking history, chronic disease such as hypertension, diabetes mellitus, obstetric history such as oligo-polihidroamnios, abortus imminent,etc previous abdominal surgeries, drug use, use of dinoprost(process) for cervical effacement, cervical Foley catheter use, use of oxytocin, duration of labor, presence of early membrane rupture, time interval from the beginning of rupture membrane, presentation, indication for cesarean section, cervikal dilatation and effacement just before the cesarean section, duration of the operation, use of additional uterotonics during the surgery, additional sutures for hemostasis, presence of atony, additional surgical interventions( uterine artery and hypogastric artery ligation, uterine compression sutures), birth weight, preoperative and post hemogram, hematocrit, white blood cell count, platelet count, blood transfusion if it was given, discharge time, and endometriosis will be recorded. Patients will be called for control examination in the third( 3rd) month after operation. And patients will be asked about clinical findings such as prolonged menstrual bleeding, midsiklus bleeding, dysmenorrhea, pelvic pain. At the same time the presence of isthmuses, the depth and the shape of the istmosel pocket and the myometrial thickness will be measured and recorded with transvaginal ultrasound. Thus, the importance of isthmocele formation on patients who had caeserean section either on latent phase or active phase of labor will be investigated . In addition , other risk factors leading to isthmocele formation will be investigated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women with the gestational weeks between 32-41 primigravida or multigravida with no history of caesarean section

排除标准

  • Gestational age below 32 weeks
  • Confirmed Plasenta Previa and/or placental invasion anomalies
  • A history Caeserean Section

结局指标

主要结局

Isthmocele Development

时间窗: 10 months

ISTHMOCELE DEVELOPMENT ACCORDİNG TO CERVİCAL DİLATATİON AND EFFACEMENTS

次要结局

未报告次要终点

研究者

发起方
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Resul Karakuş

Specialist

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

研究点 (1)

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