VocalizationTechnique During the Second Period of Labor Versus Usual Care for Prevention of Perineal Trauma: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- PERINEAL LACERATION Primary outcome: 1. Perineal laceration - present or absent
研究概览
简要总结
A randomized open-label trial will be conducted to evaluate the effect of vocalization as a perineal protection maneuver during the second period of labor. The study will be carried out in the "Espaço Aconchego" sector of the IMIP, which has a team of obstetrical nurses, medical coordination and physiotherapeutic support. The study population will consist of low-risk parturients, with no prior cesarean indication, admitted to the sector. Those parturients who meet the inclusion criteria, after signing the Informed Consent Term, will be allocated to two groups: Group A (experimental) and Group B (control). Group A will be stimulated to keep the glottis minimally open during spontaneous pushing and to emit sounds when exhaling (vocalization), and Group B will undergo usual routine. Study outcomes will be evaluated by assistents immediately after delivery. After 24 hours of delivery, the conditions of the perineum will be assessed by inspection and palpation of the region,evaluating the presence of edema or other abnormality.
详细描述
SAMPLE SIZE As there are no studies to perform an adequate sample calculation, the present study will consist of 40 women, randomly randomized to use or not the vocalization technique, 20 in each group ( pilot exploratory study).
SAMPLING Sampling shall be obtained for convenience, consecutively.
Low-risk pregnant women admitted to the "Espaço Aconchego" sector who meet the eligibility criteria, will be questioned by the researcher about the interest in participating in the study in question. The objective of the vocalization technique will be explained to the pregnant woman, with the main aim being the prevention of perineal laceration and the probable prevention of postpartum complaints. In the case of parturients above 18 years, the Free and Informed Consent Form will be given and will be read and explained aloud, and only those who freely agree to participate, signing the term, will be included in the survey. In the case of under-age parturients, the legal guardians will sign the Informed Consent.
VARIABLE DEFINITIONS
Perineal laceration: categorical variable, involving two categories:
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Low risk patients in active labor admitted to the IMIP; Gestational age between 37 and 42 weeks;
- •Cephalic fetus;
- •Cervical dilatation up to 8 cm at the time of inclusion in the study.
排除标准
- •Indication of cesarean section at the time of the approach;
- •Inability to understand and / or perform vocalization maneuvers.
- •Patients with Dysphonia
- •Deaf and mute patients
- •Use of Oxytocin prior to randomization
研究组 & 干预措施
CONTROL
In this group parturients will be attended in standardized manner, which in our hospital means a humanized approach with choice of position in socond stage and without routine episiotomy.
VOCALIZATION
In this group parturients will besides being be attended with our standar care, will receive training to vocalize during second stage.
干预措施: vocalization (Other)
结局指标
主要结局
PERINEAL LACERATION Primary outcome: 1. Perineal laceration - present or absent
时间窗: 1 hour postpartum
Presence of perineal lacerations observed by the attending staff
次要结局
- Maternal satisfaction with the management of the second period(24 hours)
- Perineal pain(24 hours)
- DURATION OF SECOND STAGE(5 hours)
- DURATION OF ACTIVE SECOND STAGE(5 hours)
- instrumental delivery(5 hours)
- laceration degree(1 hour)
- oxytocin use(5 hours)
- episiotomy(5 hours)
- Perineal edema(24 hours)
- Neonatal ICU admission(24 hour)
- Suture need(4 hours)
- Need of ressuscitation(24 hours)
- Apgar scores(5 minutes)
研究者
Leila Katz
Principal Investigator
Instituto Materno Infantil Prof. Fernando Figueira