Single Versus Double-layer Closure of The Cesarean Scar In Niche Development: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 938
- 试验地点
- 2
- 主要终点
- The proportion of Niche at 24 months after cesarean delivery of Double-layer uterine closure group
研究概览
简要总结
Rationale: Cesarean delivery (CD) rates are increasing rapidly worldwide. The consequences of cesarean section not only affect the next pregnancies such as uterine rupture or malplacentation but also cause many gynecological complications or infertility due to the formation of cesarean scar defect (CSD) or Niche. One of the major factors for Niche formation is the techniques of hysterotomy closure at the time of cesarean delivery. Most common hysterotomy closures include single and double layers closure. However, there is limited literature to prove which technique decreases niche creation and associated gynecological complications.
Objective: To compare the effect of uterine closure techniques during CD on the formation of Niche evaluated on transvaginal ultrasound and gynecological complications.
Study design: a double-blinded, single-center, randomized clinical trial. Setting: Hanoi Obstetrics & Gynecology Hospital (HOGH), Viet Nam. Study population: All women at gestational age ≥ 37 0/7 weeks who undergo a primary CD (planned or unplanned).
Intervention: After informed consent, women will be randomized to either unlocked single layer closure or unlocked double-layer closures of cesarean uterine scar in a 1:1 ratio Primary outcome: The proportion of Niche over time (at 6, 12, 18, 24 months after CD) in the two groups.
Power calculation: A sample size of 389 women is needed for each group. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Both uterine closure methods followed by the Vietnam Ministry of Health (VN-MOH), transvaginal ultrasound is also not harmful. It is believed that there are no potential increased risks to patients taking part in this trial because of the standard care and management they receive.
详细描述
Pregnancies at term, indicated for cesarean delivery for the first time, will be fully consulted information related to this study before surgery. Written consent will be obtained from each eligible pregnant woman before randomization into the study.
After signing the informed consent form, eligible women will be randomly assigned in a 1:1 ratio to receive either single-layer closure or double-layer closure, using block randomization with a variable block size of 4, 6. The computer-generated random list will be prepared by an independent statistician who has no other involvement in the study. To ensure allocation concealment, opaque and sealed envelopes will be prepared and controlled by two administrative staff in the Clinical Trial Unit who have no involvement in clinical work. Whenever there is an eligible participant, these two staff will hand over the envelope in sequence to the clinician. As the result, surgeons will not be blinded, but participants and sonographers will be unaware of closure techniques. Apart from randomization, patients will be followed up and treated according to local protocol.
The cesarean section with two uterine scar closure techniques will be performed by well-trained obstetricians. Participants and sonographers will be blinded for the closure technique.
Intervention (double-layer closure) In both study groups, women will undergo a CD following a standard way with respect to the mode of hysterotomy, non-closure of the peritoneum. In the intervention group, double-layer closure of the uterus will be performed using unlocked multifilament continuous running sutures for both layers and the endometrial layer will be included in the first layer. The second layer is a continuous running suture that imbricates the first layer.
Control group (single-layer closure) The control group will receive a single-layer closure using unlocked continuous running multifilament sutures and the endometrial layer will be included.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who undergo a primary CD (planned or unplanned)
- •Age ≥ 18 years.
- •Gestational age ≥ 37 0/7 weeks
排除标准
- •Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection).
- •Women with abnormal menstrual bleeding (e.g. cervical dysplasia, communicating hydrosalpinx, uterine anomaly or endocrine disorders disturbing ovulation, drugs, polyps, fibroids, etc.).
- •Women with dysmenorrhea, dyspareunia, suprapubic pain.
- •Abnormal placenta: Placenta privia, Placenta percreta... in the current pregnancy.
结局指标
主要结局
The proportion of Niche at 24 months after cesarean delivery of Double-layer uterine closure group
时间窗: from delivery to 24 months from delivery
The proportion of Niche at 24 months after cesarean delivery of Double-layer uterine closure group.
The proportion of Niche at 18 months after cesarean delivery of Single-layer uterine closure group
时间窗: from delivery to 18 months from delivery
The proportion of Niche at 18 months after cesarean delivery of Single-layer uterine closure group.
The proportion of Niche at 6 months after cesarean delivery of Single-layer uterine closure group
时间窗: from delivery to 6 months from delivery
The proportion of Niche at 6 months after cesarean delivery of Single-layer uterine closure group.
The proportion of Niche at 12 months after cesarean delivery of Single-layer uterine closure group
时间窗: from delivery to 12 months from delivery
The proportion of Niche at 12 months after cesarean delivery of Single-layer uterine closure group.
The proportion of Niche at 24 months after cesarean delivery of Single-layer uterine closure group
时间窗: from delivery to 24 months from delivery
The proportion of Niche at 24 months after cesarean delivery of Single-layer uterine closure group.
The proportion of Niche at 18 months after cesarean delivery of Double-layer uterine closure group
时间窗: from delivery to 18 months from delivery
The proportion of Niche at 18 months after cesarean delivery of Double-layer uterine closure group.
The proportion of Niche at 6 months after cesarean delivery of Double-layer uterine closure group
时间窗: from delivery to 6 months from delivery)
The proportion of Niche at 6 months after cesarean delivery of Double-layer uterine closure group.
The proportion of Niche at 12 months after cesarean delivery of Double-layer uterine closure group
时间窗: from delivery to 12 months from delivery
The proportion of Niche at 12 months after cesarean delivery of Double-layer uterine closure group.
次要结局
- Number of participants with maternal infection(from delivery until maternal hospital discharge, assessed up to 28 days after delivery)
- Number of participants suffering from suprapubic pain in women with Niche(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Number of participants suffering from dyspareunia in women with Niche(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Number of participants with post-partum hemorrhage.(Within 24 hours from delivery)
- Dysmenorrhea severity in women with Niche(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Suprapubic pain severity in women with Niche(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Number of participants having postmenstrual spotting in women with Niche(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Niche length(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Residual myometrial thickness (RMT)(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Number of participants having uterine atony(During operation)
- Number of participants suffering from dysmenorrhea in women with Niche(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Ratio of residual myometrial thickness per adjacent myometrial thickness (RMT/AMT)(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Duration of postmenstrual spotting in women with Niche(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Niche depth(: from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Niche-external os distance(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Evaluating the correlation between Niche characteristics and gynecological symptoms(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Comparison between the rate of niche detection by regular TVUS and sonohysterography(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Dyspareunia severity in women with Niche(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Number of branches of Niche(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Niche-vesicovaginal fold distance(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
- Evaluating factors contributing to Niche development(from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery)
研究者
Nguyen Thi Thu Ha
Deputy Director
Hanoi Obstetrics and Gynecology Hospital