Clinical Impact of Uterine Repair During Cesarean Section with Barbed Suture on the Incidence of Isthmocele and Its Ultrasound and Molecular Characteristics: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Rate of Isthmocele
研究概览
简要总结
Pregnant women, irrespective of their pregnancy risk, who undergo a cesarean section for any reason will be randomized to one of two suturing techniques: conventional suture or barbed suture for uterine repair after the cesarean section. Following surgery, these patients will be followed up for clinical outcomes, ultrasound evaluation of the uterine scar, and study of the hypoxic-inflammatory environment of the uterine cavity.
详细描述
A randomized controlled trial will be conducted among pregnant women, irrespective of their pregnancy risk, undergoing cesarean sections at a tertiary care hospital. Participants will be randomly assigned to one of two groups: the intervention group, which will receive barbed suture for myometrial repair following the cesarean section, or the control group, which will receive conventional smooth suture. This study aims to compare a range of outcomes related to clinical, ultrasonographic, and molecular parameters of the uterine scar and the development of isthmocele.
Main hypothesis: The use of barbed suture for hysterorrhaphy during cesarean section, compared to conventional smooth sutures, results in reduced ischemia and necrosis of the myometrial tissue, facilitating better healing. This is associated with a lower incidence of isthmocele at six months postpartum, and a decrease in its ultrasound dimensions, evaluated by transvaginal ultrasound with hysterosonography.
Secondary hypothesis:
- The use of barbed suture during cesarean delivery leads to a reduction in molecular biomarker levels of hypoxia and inflammation within the uterine cavity.
- The employment of barbed suture is associated with a decrease in the frequency of symptoms related to isthmocele in the short term, or a lower intensity of symptoms if they occur, compared to conventional suture.
- Patients who develop isthmocele after cesarean delivery present predisposing myometrial characteristics and additional risk factors compared to patients with normal healing.
- The study of myometrial texture patterns based on ultrasound images of the uterine wall in the postpartum period following cesarean delivery may provide predictive data regarding the risk of developing isthmocele at six months postpartum.
- The stiffness of the uterine scar measured by the strain ratio (SR) is lower among patients included in the barbed suture group than in patients in the conventional suture group.
- Uterine repair with barbed suture during the cesarean section leads to better perinatal outcomes in the subsequent pregnancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who deliver at Hospital Clinic of Barcelona by a planned, intrapartum or urgent cesarean section, irrespective of their pregnancy risk.
- •Had accepted to participate in the study during the third trimester of gestation.
- •Patients who accept a 6-month follow-up visit.
- •Minimal maternal age of 18 years old.
排除标准
- •Patients who end up delivering in another center.
- •Patients who deliver by vaginal route.
- •Patients diagnosed with isthmocele prior to the current pregnancy.
- •Need for histerectomy in the following 6 months after delivery.
- •Patients with known allergies to any of the components of the barbed suture.
研究组 & 干预措施
Study Group: Uterine repair with barbed suture
Uterine closure following cesarean section is carried out using an unlocked single-layer barbed suture with an endometrium-free technique.
干预措施: Barbed suture (Device)
Control Group: Uterine repair with conventional smooth suture
Uterine repair following cesarean section is performed using a conventional smooth polyglactin suture with a continuous single-layer, endometrium-free technique, in accordance with the standard procedure at our center.
干预措施: Conventional smooth suture (Device)
结局指标
主要结局
Rate of Isthmocele
时间窗: Six months after cesarean section.
Rate of isthmocele six months after cesarean section examined by transvaginal ultrasonography with hysterosonography.
Ultrasonographic Measurements of Isthmocele
时间窗: Six months after cesarean section.
Ultrasonographic characteristics of isthmocele measured by niche length, niche depth, niche width, residual myometrial thickness (RMT) and niche size (niche depth/niche depth+RMTx100\[%\]).
次要结局
- Intrauterine molecular markers of hypoxia and inflammation(Six months after cesarean section.)
- Symptoms(Six months after cesarean section.)
- Risk factors(Through study completion, an average of 2 years.)
- Ultrasonographic myometrial texture patterns(Six months after cesarean section.)
- Stiffness of the uterine scar(Six months after cesarean section.)
- Perinatal outcomes in following pregnancies(Through study completion, an average of 4 years.)
研究者
Cristina Mula Navarro
SPECIALIST IN OBSTETRIC AND GYNECOLOGY, MD
Hospital Clinic of Barcelona