Evaluation of Crowning Time on the Incidence of Levator Ani Muscle Avulsion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Number of participants with complete and partial unilateral or bilateral avulsion of the levator ani muscles in the post-partum period
研究概览
简要总结
Levator ani muscle is one of the main components of perineal muscles and plays a crucial role in urinary continence and pelvic organ support. An avulsion, detachment from its insertion, of this muscle can occur during vaginal birth. It is well known that this major injury can cause many symptoms such as urinary incontinence and pelvic organ prolapses. Some risk factors of this important injury have been identified in the literature, such as the use of forceps. However, to date, no study has evaluated the impact of the crowning of the fetal head during labor on perineal muscles, specifically the levator ani muscle avulsion. Hence, the objectives of this study are to evaluate the association i) the time of the crowning of the fetal head during labor and levator ani muscle avulsion, ii) the time of the crowning of the fetal head and urogynecological symptoms, and iii) use of episiotomy and levator ani muscle avulsion. Postpartum primiparous women will undergo a 4D transperineal ultrasound to evaluate their pelvic muscles and complete questionnaires assessing urogynecological symptoms.
详细描述
This is a prospective cohort study evaluating the impact of the crowning time of the fetal head in the second stage of labor on the incidence of levator ani muscle avulsion. Levator ani muscle is hypothesized to avulse during the distension of the pelvic floor muscles, as during a forceps use, and most probably during the crowning of the fetal head. In the study center, the crowning of the fetal head is systematically calculated during labor by nurses and doctors. To eliminate some potential confounding factors, only primiparous women with spontaneous vaginal delivery of a vertex position baby will be recruited in the post-partum period. In order to evaluate the presence of levator ani muscle avulsion, they will be assessed with a 4D transperineal ultrasound by using a standard diagnosis protocol. The delivery hospital file will then be examined to collect potential confounding variables. Prior to data collection, all study participants will give their written informed consent. This study will add more literature to the prevention of the levator ani muscle avulsion and its long-term complications.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparous women GxT1 At term: ≥ 37+0 weeks of gestation (included) Spontaneous vaginal delivery (SVD) Cephalic presentation History of miscarriage before 20 weeks or with a fetal weight < 350g
排除标准
- •Contraindications to vaginal delivery Assisted vaginal delivery Age under 18 years Shoulder dystocia Extensive pelvic reconstructive surgery (e.g., bladder exstrophy repair) Term intrauterine fetal demise Twin or multifetal pregnancy
结局指标
主要结局
Number of participants with complete and partial unilateral or bilateral avulsion of the levator ani muscles in the post-partum period
时间窗: In the post-partum period, up to 1 year post-partum
Diagnostic established with standard levator-urethra gap measures assessed with a transperineal 4D ultrasound
Crowning time of the fetal head
时间窗: The data was obtained from the medical records of each participant during labor.
The time between the crowning of the fetal head and birth is systematically recorded during labor at the study center for all deliveries. Only participants who meet the inclusion criteria are considered for the study.
次要结局
- Rate and type of perineal tears(The data was obtained from the medical records of each participant during labor.)
- Use of episiotomy(The data was obtained from the medical records of each participant during labor.)
- Incidence and severity of urogynecological symptoms(In the post-partum period, up to 1 year post-partum)
研究者
Mélanie Morin
Clinical Professor
Université de Sherbrooke