The Effect of Episiotomy on Advanced Perineal Tears and Other Maternal and Fetal Outcomes - Randomized Controlled Multicentric Trial (EPITRIAL)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 676
- 试验地点
- 1
- 主要终点
- Obstetric Anal Sphincter injury
研究概览
简要总结
This study is aimed to evaluate the influence of episiotomy on various maternal and neonatal outcomes. Half of the participants will undergo selective episiotomy (according to routine delivery management at the particular hospital), while the other half will not undergo epitiotomy at all.
Our hypothesis is that no differences in maternal and neonatal outcomes will be demonstrated between these two groups.
详细描述
Episiotomy is one of the most prevalent surgical interventions at the delivery room, ranging in frequency from about 10% and up to 75%. The presumed benefits of this procedure include prevention of advanced (3rd and 4th degree) perineal tears, facilitation of fetal distress, easier suturing compared to that of spontaneous perineal tears, decreased postpartum pelvic organ injury including reduced risk of urinary and anal incontinence, and facilitation of labor in cases of shoulder dystocia. However, the cumulative evidence in the recent decades strongly points to the lack of episiotomy efficiency. Moreover, many studies indicate that episiotomy may be associated with increased maternal morbidity in terms of postpartum bleeding and pain, urinary incontinence and severe perineal tears. Cochrane Collaboration meta-analysis of randomized controlled trials has shown that selective episiotomy significantly decreases the risk of advanced perineal tears (relative risk of 0.67) and the overall need for perineal suturing (relative risk of 0.71), compared to routine episiotomy use. In addition, there is no uniform definition for the indications for episiotomy performance.
In accordance with literature evidence, we hypothesized that avoidance of episiotomy is not associated with increased risk of maternal and neonatal complications, compared to selective episiotomy use. Thus, the objective of our study is to compare maternal and neonatal outcomes in the group with no episiotomy performed to selective episiotomy use.
This randomized controlled clinical trial will be conducted in seven Northern public Israeli Hospitals from February 2015 to February 2019.
The following study protocol was constructed using consultation with experienced epidemiologist and several senior obstetricians.
Women fitting the inclusion criteria will receive a detailed explanation about the trial from one of the approved investigators and will carefully read the relevant forms. In case of agreement for participation in the study, informed consent form will be signed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women in labor, or women scheduled for induction of labor, or women attending for a routine follow-up examination during third trimester of pregnancy.
- •First vaginal delivery
- •Singleton pregnancy above 34 gestational weeks
- •Vertex presentation
- •Women who are able to understand and sign the informed consent forms.
排除标准
- •Absolute contraindications for vaginal delivery (e.g. placenta previa, fetal macrosomia above 4.5 kg, genital herpes)
结局指标
主要结局
Obstetric Anal Sphincter injury
时间窗: From the delivery to one hour after delivery
Advanced (3rd and 4th degree) perineal tears, i.e. perineal lacerations involving the anal sphincter, diagnosed by a senior obstetrician
次要结局
- Postpartum hemorrhage(From delivery to one hour postpartum)
- Cord blood pH(From the delivery to first two minutes after delivery)
- Characteristics of suturing procedure (The duration of suturing procedure, number of suture packs used during the suturing, subjective grading of suturing difficulty and need for extended suturing in operative room)(During suturing (from the delivery to one hour after the delivery))
- Postpartum symptoms two days after the delivery (Perineal pain evaluation using 11 points (0-10) Verbal Numeric Scale, urinary retention, perineal infection, perineal hematoma requiring surgical drainage, symptoms of urinary/anal incontinence)(During the second day after the delivery)
- Phone-call evaluation two months after the delivery(Two months after the delivery)
- Admission to Neonatal Intensive Care Unit (NICU)(From the delivery to one hour after delivery)
- Phone-call evaluation one year after the delivery (Two questionnaires)(One year after the delivery)
- 1st and 2nd degree perineal tears(From the delivery to one hour after delivery)
- Neonatal Apgar score(From the delivery to five minutes after delivery)
- Episiotomy performance parameters (Indication for episiotomy performance)(During suturing (from the delivery to one hour after the delivery))
- Duration of the second stage of labor(From beginning of full dilatation to the delivery of the baby)
- Need of any neonatal resuscitation procedures(From the delivery to one hour after delivery)
- Shoulder dystocia(From the delivery of the head to the delivery of the shoulders or longer than 60 seconds interval between the delivery of the head to the delivery of the shoulders)
研究者
Lena Sagi-Dain
Senior Obstetrician, Department of Obstetrics and Gynecology
Carmel Medical Center