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临床试验/NCT04681378
NCT04681378已完成不适用

A New Technique for Uterine Incision Closure at The Time of Cesarean Section: Does it Make a Difference

Menoufia University0 个研究点目标入组 120 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
主要终点
residual myometrial thickness

研究概览

简要总结

The purpose of this study was to compare the short term operative outcomes of three different surgical techniques for uterine incision closure during cesarean section (CS).

This trial enrolled 120 patients scheduled for primary cesarean delivery. Patients were randomized into either classical double layer uterine closure, purse string double layer uterine closure (Turan), or our new approach of uterine closure (double layer step up-step down technique). For short term comparison, transvaginal ultrasonography was planned for all patients 6 weeks after surgery. Compared to group II and Group III, residual myometrial thickness was significantly thinner in group I (P< 0.001). The number of patients with uterine niche was 10 (50% of all scar defects) in group I whereas it was 4 (20%) in group II and 6 (30%) in group III. Operative time was significantly longer in group II (P< 0.001). This led to our conclusion that Turan technique and our new approach are associated with thicker myometrial thickness and less frequency of uterine scar defect than classical double layer uterine incision closure; however, our approach takes less operative time.

详细描述

The investigators performed single site randomized clinical trial that was conducted at department of Obstetrics and Gynecology, Menoufia University Hospital, which is a large tertiary center in the Delta region in Egypt. The study population consisted of 120 eligible pregnant women with a singleton first-time cesarean delivery without preterm rupture of membranes, contractions or cervical dilatations that were recruited from the inward section one day before surgery from January 2017 to April 2019; only 114 cases remained for analysis. The study was approved by our hospital ethics committee and a written consent was obtained from each participant woman after full explanation of the study design. No important changes occurred to the trial design after it began, and the CONSORT guidelines was observed and completed.

Exclusion criteria were: pregnant women who refused to participate, women under age of 18 years, history of previous CS or any other uterine surgery ( Hystrotomy , myomectomy, perforation),placenta previa, abruptio placenta, fibroids located in the cervical or the cervico-corporal border, presence of maternal disease ( diabetes mellitus, anemia, connective tissue disorders, uterine malformations), reoperation following the CS, and presence of chorioamnionits. Secondary exclusion criteria were the need for more than three additional single sutures for hemostasis.

One author evaluated all obstetric patients who applied to the delivery room within the study period and selected eligible cases. After excluding patients who did not meet the inclusion criteria and patients who refused to participate, all remaining patients were equally randomized into either classical double layer uterine closure (group I), purse string double layer uterine closure (Turan technique, group II), or our technique of double layer step up- step down uterine closure (group III).

A computer-generated random numerical table (Randomization Generator Version 1.0) was used by our statistical department to prepare sealed opaque envelopes containing a group assignment. Three groups of envelopes-corresponding to the study groups were given to an anesthesia nurse. The nurse distributed envelopes to patients, alternating between groups during preanesthetic consultation. The patients were blinded the groups, and two authors performed the operations randomly. Another author who was blinded to the suturing technique performed all of the ultrasonographic examinations at 6 week follow up visit.

All cesarean deliveries were performed under spinal anesthesia. An abdominal opening was made through a slightly curved transverse incision that was placed 3-4 cm above the symphysis pubis (Pfannestiel incision). The subcutaneous tissue was left untouched apart from midline. The rectus sheath was separated along its fibers and the rectus muscles pulled apart. Stretching with index fingers opened the peritoneum and the uterus was opened by transverse lower segment incision (Kerr incision), then the hole was enlarged between the index finger of one hand and the thumb of the other hand.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

A computer-generated random numerical table (Randomization Generator Version 1.0) was used by our statistical department to prepare sealed opaque envelopes containing a group assignment. Three groups of envelopes-corresponding to the study groups were given to an anesthesia nurse. The nurse distributed envelopes to patients, alternating between groups during preanesthetic consultation. The patients were blinded the groups, and two authors performed the operations randomly. Another author who was blinded to the suturing technique performed all of the ultrasonographic examinations at 6 week follow up visit.

入排标准

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

入选标准

  • pregnant women with a singleton prior cesarean section
  • first-time cesarean delivery
  • without preterm rupture of membranes, contractions or cervical dilatations

排除标准

  • women under age of 18 years
  • history of previous CS or any other uterine surgery
  • placenta previa, abruptio placenta, fibroids located in the cervico-corporal border
  • Maternal disease ( diabetes mellitus, anemia, connective tissue disorders, uterine malformations).

结局指标

主要结局

residual myometrial thickness

时间窗: 6 weeks after surgery

The cesarean scar site was identified as a small triangular anechoic defect in the anterior wall of the uterus (uterine niche). In these patients RMT was measured from the top of niche to serosal surface. In patients without a scar defect RMT was measured from the delineation of the endometrium to the serosal surface at the level of CS scar and total myometrial thickness was measured at the myometrium adjacent to CS scar in all patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nabih Elkhouly

associate professor

Menoufia University

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